Nasal Cannula Dislodgement During Sleep in Veterans Receiving Long-term Oxygen Therapy for Hypoxemic Chronic Respiratory Failure

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The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table_1.png

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure.png

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table_3.png
table_2.png

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

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Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein (irubinst@uic.edu)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

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Author and Disclosure Information

Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein (irubinst@uic.edu)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

Author and Disclosure Information

Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein (irubinst@uic.edu)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

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Article PDF

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table_1.png

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure.png

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table_3.png
table_2.png

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table_1.png

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure.png

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table_3.png
table_2.png

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0424 FED O2 Therapy</fileName> <TBEID>0C02F3C0.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F3C0</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240408T155151</firstPublished> <LastPublished>20240408T155151</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240408T155151</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher </metaDescription> <articlePDF/> <teaserImage/> <title>Nasal Cannula Dislodgement During Sleep in Veterans Receiving Long-term Oxygen Therapy for Hypoxemic Chronic Respiratory Failure</title> <deck/> <eyebrow>Original Study</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>April</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>4</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>2951</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>April 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Feature | 2951<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">104</term> </sections> <topics> <term canonical="true">284</term> <term>27442</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Nasal Cannula Dislodgement During Sleep in Veterans Receiving Long-term Oxygen Therapy for Hypoxemic Chronic Respiratory Failure</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>B</b><b>ackground: </b>Chronic obstructive pulmonary disease (COPD) is highly prevalent in male veterans. Long-term oxygen therapy (LTOT) can effectively reduce all-cause mortality in these patients, but the effects of nasal cannula dislodgement (NCD) during sleep have not been well studied. <hl name="33679"/><br/><br/><b>Methods: </b>This study sought<b> </b>to determine whether veterans receiving LTOT for hypoxemic chronic respiratory failure (CRF) due to COPD reported NCD while they slept and, if so, its impact on hospitalizations for COPD exacerbations. Electronic health records were reviewed of veterans with hypoxemic CRF due to COPD who received LTOT and were followed in the pulmonary clinic at the Jesse Brown Veterans Affairs Medical Center between February 1, 2022, and December 31, 2022. Overall hospital cost was calculated for each hospitalized veteran with diagnosed COPD exacerbation. Veterans reported whether they experienced NCD during sleep and, if so, its frequency. <br/><br/><b>Results<hl name="33680"/>:</b> <hl name="33681"/>Interviews were conducted with 66 veterans with a mean age of 71 years. Twenty-two veterans (33%) reported NCD ≥ 1 weekly (median, 4). There were no statistically significant differences in demographics, supplemental oxygen flow rate, duration of LTOT, and pulmonary function tests between patients with and without NCD. Ten patients (45%) with NCD and 9 patients (20%) without NCD were hospitalized for ≥ 1 COPD exacerbation (<i>P</i> = .045). Three patients (14%) with NCD were admitted to the medical intensive care unit. Overall hospital costs were 25% higher in the NCD group compared with the no NCD group.<br/><br/><b>Conclusions<hl name="33682"/>:</b> Veterans receiving LTOT for hypoxemic CRF due to COPD who report frequent NCD during sleep have higher hospitalization rates for COPD exacerbation and higher hospital costs.</p> <p><span class="Drop">T</span>he prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.<sup>1</sup> Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).<sup>2-5</sup> It has been well established that LTOT reduces all-cause mortality in patients with COPD and <hl name="33683"/>resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.<sup>6-8</sup> </p> <p>Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. <hl name="7"/>Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.<sup>8,9</sup> Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.<sup>10-13</sup>The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on <hl name="8"/>their hospitalizations for COPD exacerbations. </p> <h2>METHODS</h2> <p>We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed <hl name="9"/>in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.<sup>14</sup> A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence. </p> <p>Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.<sup>15</sup> We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.</p> <h3>Data Analysis</h3> <p>Data were reported as mean (SD) where appropriate. The<i> t</i> test and Fisher exact test were used as indicated. <i>P</i> &lt; .05 was considered statistically significant.<b> </b>The study protocol <hl name="10"/>was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).</p> <h2>RESULTS</h2> <p>During the study period, <hl name="11"/><hl name="12"/>75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.</p> <p>Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2). <br/><br/>Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (<i>P</i> = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.</p> <h2>DISCUSSION</h2> <p>There are 3 new findings in this study. <hl name="13"/><hl name="14"/>First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with <hl name="15"/>hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups. </p> <p>Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.<sup>16</sup> Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.<sup>11,13</sup> Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.<sup>10,12</sup> The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.<br/><br/>To the best of our knowledge, NCD during sleep has not been previously reported in patients <hl name="16"/>with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.<sup>17-20</sup> Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.</p> <h3>Limitations</h3> <p>This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare &amp; Medicaid Services or commercial carrier data may be different.<sup>15,21</sup> Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.<sup>14</sup> This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD. </p> <h2>CONCLUSIONS</h2> <p><hl name="17"/>Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.</p> <p class="isub">Acknowledgments</p> <p> <em>We thank Yolanda Davis, RRT, and George Adam for their assistance with this project. </em> </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois<br/><br/><sup>b</sup>University of Illinois Chicago College of Pharmacy</em> </p> <p class="isub">Author roles</p> <p> <em>All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript. </em> </p> <p class="isub">Disclosures</p> <p> <em>This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).</em> </p> <h2><hl name="18"/>References</h2> <p class="reference"> 1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. <i>Natl Health Stat Report</i>. 2021;(153):1-13. doi:10.15620/cdc:101659<br/><br/> 2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. <i>Int J Chron Obstruct Pulmon Dis</i>. 2010;5:125-132. doi:10.2147/copd.s8047<br/><br/> 3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. <i>Chronic Obstr Pulm Dis</i>. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201<br/><br/> 4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. <i>Cost Eff Resour Alloc</i>. 2013;11:13. doi:10.1186/1478-7547-11-13<br/><br/> 5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. <i>Int J Chron Obstruct Pulmon Dis</i>. 2022;17:1269-1283. doi:10.2147/COPD.S339323<br/><br/> 6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. <i>Cochrane Database Syst Rev</i>. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2<br/><br/> 7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. <i>Am J Respir Crit Care Med</i>. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI<br/><br/> 8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. <i>Am J Respir Crit Care Med</i>. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST<br/><br/> 9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision &amp; update. <i>Respir Care</i>. 2007;52(8):1063-1068. <br/><br/>10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. <i>PLoS One.</i> 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618<br/><br/>11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. <i>Am J Respir Crit Care Med</i>. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC<br/><br/>12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. <i>COPD</i>. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357<br/><br/>13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. <i>Respir Res</i>. 2022;23(1):213. doi:10.1186/s12931-022-02123-5<br/><br/>14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947<br/><br/>15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&amp;D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf<br/><br/>16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. <i>Eur Respir Rev</i>. 2011;20(121):183-194. doi:10.1183/09059180.00004311<br/><br/>17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. <i>Am J Respir Crit Care Med</i>. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS<br/><br/>18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. <i>Expert Rev Clin Pharmacol</i>. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457<br/><br/>19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. <i>Respir Care</i>. 2019;64(12):1574-1585. doi:10.4187/respcare.07135<br/><br/>20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. <i>Ann Am Thorac Soc</i>. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC<br/><br/>21. US Centers for Medicare &amp; Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169</p> </itemContent> </newsItem> </itemSet></root>
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Battlefield Acupuncture vs Ketorolac for Treating Pain in the Emergency Department

Article Type
Changed
Wed, 04/12/2023 - 09:05

Acute pain is a primary symptom for many patients who present to the emergency department (ED). The ED team is challenged with relieving pain while limiting harm from medications.1 A 2017 National Health Interview Survey showed that compared with nonveterans, more veterans reported pain in the previous 3 months, and the rate of severe pain was 40% higher in the veteran group especially among those who served during the era of wars in Afghanistan and Iraq.2

The American College of Emergency Physicians guidelines pain management guidelines recommend patient-centered shared decision making that includes patient education about treatment goals and expectations, and short- and long-term risks, as well as a preference toward pharmacologic treatment with nonopioid analgesics except for patients with severe pain or pain refractory to other drug and treatment modalities.3 There is a lack of evidence regarding superior efficacy of either opioid or nonopioid analgesics; therefore, the use of nonopioid analgesics, such as oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs) or central analgesics, such as acetaminophen, is preferred for treating acute pain to mitigate adverse effects (AEs) and risks associated with opioid use.1,3,4 The US Department of Veterans Affairs (VA) and Department of Defense (DoD) guideline on managing opioid therapy for chronic pain, updated in 2017 and 2022, similarly recommends alternatives to opioids for mild-to-moderate acute pain and encourages multimodal pain care.5 However, use of other pharmacologic treatments, such as NSAIDs, is limited by AE profiles, patient contraindications, and severity of acute pain etiologies. There is a need for the expanded use of nonpharmacologic treatments for addressing pain in the veteran population.

The American College of Emergency Physicians guidelines recommend nonpharmacologic modalities, such as applying heat or cold, physical therapy, cognitive behavioral therapy, and acupuncture.3 A 2014 study reported that 37% to 46% of active duty and reserve military personnel use complementary and alternative medicine (CAM) for a variety of ailments, and there is increasing interest in the use of CAM as adjuncts to traditional therapies.6 According to one study, some CAM therapies are used significantly more by military personnel than used by civilians.7 However, the percentage of the veteran population using acupuncture in this study was small, and more information is needed to assess its use.

Auricular acupuncture originated in traditional Chinese medicine.8 Contemporary auricular acupuncture experts view this modality as a self-contained microsystem mapping portions of the ear to specific parts of the body and internal organs. The analgesic effects may be mediated through the central nervous system by local release of endorphins through nerve fiber activation and neurotransmitters—including serotonin, dopamine, and norepinephrine—leading to pre- and postsynaptic suppression of pain transmission.

Battlefield acupuncture (BFA) uses 5 set points anatomically located on each ear.9 Practitioners use small semipermanent, dartlike acupuncture needles. Patients could experience pain relief in a few minutes, which can last minutes, hours, days, weeks, or months depending on the pathology of the pain. This procedure developed in 2001 has been studied for different pain types and has shown benefit when used for postsurgical pain, chronic spinal cord injury−related neuropathic pain, and general chronic pain, as well as for other indications, such as insomnia, depression, and weight loss.8,10-13 In 2018, a randomized controlled trial compared postintervention numeric rating scale (NRS) pain scores in patients presenting to the ED with acute or acute-on-chronic lower back pain who received BFA as an adjunct to standard care vs standard care alone.14 Patients receiving BFA as an adjunct to standard care were found to have mean postintervention pain scores 1.7 points lower than those receiving standard care alone. This study demonstrated that BFA was feasible and well tolerated for lower back pain in the ED as an adjunct to standard care. The study was limited by the adjunct use of BFA rather than as monotherapy and by the practitioners’ discretion regarding standard care, which was not defined by the study’s authors.

 

 


The Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, offers several CAM modalities, such as exercise/movement therapy, chiropractic, art/music therapy, and relaxation workshops, which are widely used by veterans. Recent evidence suggests BFA could reduce pain scores as an adjunct or an alternative to pharmacologic therapy. We are interested in how CAM therapies, such as BFA, can help avoid AEs associated with opioid or NSAID therapy.

At the JBVAMC ED, ketorolac 15 mg is the preferred first-line treatment of acute, noncancer pain, based on the results of previous studies. In 2018 BFA was offered first to veterans presenting with acute or acute-on-chronic pain to the ED; however, its effectiveness for pain reduction vs ketorolac has not been evaluated in this patient population. Limited literature is available on BFA and its use in the ED. To our knowledge, this was the first observational study assessing the difference between a single session of BFA vs a single dose of ketorolac in treating noncancer acute or acute-on-chronic pain in the ED.

Methods

This study was a retrospective chart review of patients who presented to the JBVAMC ED with acute pain or acute-on-chronic pain, who received ketorolac or BFA. The study population was generated from a list of all IV and intramuscular (IM) ketorolac unit dose orders verified from June 1, 2018, through August 30, 2019, and a list of all BFA procedure notes signed from June 1, 2018, through August 30, 2019. Patients were included in the study if they had documented administration of IV or IM ketorolac or BFA between June 1, 2018, and August 30, 2019. Patients who received ketorolac doses other than 15 mg, the intervention was administered outside of the ED, received adjunct treatment in addition to the treatment intervention in the ED, had no baseline NRS pain score documented before the intervention, had an NRS pain score of < 4, had no postintervention NRS pain score documented within 6 hours, had a treatment indication other than pain, or had active cancer were excluded. As in previous JBVAMC studies, we used NRS pain score cutoffs (mild, moderate, severe, and very severe) based on Woo and colleagues’ meta-analysis and excluded scores < 4.15

Endpoints

The primary endpoint was the mean difference in NRS pain score before and after the intervention, determined by comparing the NRS pain score documented at triage to the ED with the first documented NRS pain score at least 30 minutes to 6 hours after treatment administration. The secondary endpoints included the number of patients prescribed pain medication at discharge, the number of patients who were discharged with no medications, and the number of patients admitted to the hospital. The safety endpoint included any AEs of the intervention. Subgroup analyses were performed comparing the mean difference in NRS pain score among subgroups classified by severity of baseline NRS pain score and pain location.

Statistical Analysis

Baseline characteristics and endpoints were analyzed using descriptive statistics. Categorical data were analyzed using Fisher exact test and z test for proportions, and continuous data were compared using t test and paired t test. An 80% power calculation determined that 84 patients per group were needed to detect a statistically significant difference in pain score reduction of 1.3 at a type-1 error rate of 0.05. The sample size was based on a calculation performed in a previously published study that compared IV ketorolac at 3 single-dose regimens for treating acute pain in the ED.16 The 1.3 pain score reduction is considered the minimum clinically significant difference in pain that could be detected with the NRS.17

 

 

Results

Sixty-one patients received BFA during the study period: 31 were excluded (26 received adjunct treatment in the ED, 2 had active cancer documented, 2 had an indication other than pain, and 1 received BFA outside of the ED), leaving 30 patients in the BFA cohort. During the study period, 1299 patients received ketorolac. These patients were selected using a random number generator and then screened to determine inclusion or exclusion in the study. We continued to randomly select patients for the ketorolac group until we had a similar number in each treatment group. Of these 148 patients who were randomly selected to be reviewed, 116 were excluded: 48 received adjunct treatment in the ED, 24 had no postintervention NRS pain score documented within 6 hours, 18 received ketorolac doses other than 15 mg, 12 received ketorolac outside the ED, 9 had no baseline NRS pain score documented, 3 presented with a NRS pain score of ≤ 3, and 2 had active cancer documented. The ketorolac cohort comprised 31 patients.

Baseline characteristics were similar between the 2 groups except for the average baseline NRS pain score, which was statistically significantly higher in the BFA vs ketorolac group (8.7 vs 7.7, respectively; P = .02). The mean age was 51 years in the BFA group and 48 years in the ketorolac group. Most patients in each cohort were male: 80% in the BFA group and 71% in the ketorolac group. The most common types of pain documented as the chief ED presentation included back, lower extremity, and head.

table_1.png
Ten patients in the BFA group and 3 in the ketorolac group presented with lower extremity pain (P = .02) (Table 1).

Endpoints

The mean difference in NRS pain score was 3.9 for the BFA group and 5.1 for the ketorolac group. Both were clinically and statistically significant reductions (P = .03 and P < .01), but the difference between the intervention groups in NRS score reduction was not statistically significant (P = .07).

For the secondary endpoint of outpatient prescriptions written at discharge, there was no significant difference between the groups except for oral NSAIDs, which were more likely to be prescribed to patients who received ketorolac (P = .01).

table_2.png
Patients who received BFA were more likely to receive oral muscle relaxants or topical analgesics, but the difference between the groups was not statistically significant (Table 2). There was no difference in the number of patients who received no prescriptions at ED discharge. Patients who received ketorolac were more likely to be admitted to the hospital (P = .049) (Table 3).
table_3.png
 No AEs were observed in either treatment group during the study.

Subgroup Analysis

An analysis was performed for subgroups classified by baseline NRS pain score (mild: 4; moderate, 5 - 6; severe, 7 - 9; and very severe, 10). Data for mild pain was limited because a small number of patients received interventions. For moderate pain, the mean difference in NRS pain score for BFA and ketorolac was 3.5 and 3.8, respectively; for severe pain, 3.4 and 5.3; and for very severe pain, 4.6 and 6.4. There was a larger difference in the preintervention and postintervention NRS pain scores within severe pain and very severe pain groups.

figure.png
The mean difference in NRS pain score reduction between the intervention groups was not statistically significant for any subgroup (Figure).
table_4.png
A subgroup analysis also was performed comparing pain locations, although no statistically significant difference was found among the subgroups (Table 4).

Discussion

Both interventions resulted in a significant reduction in the mean NRS pain score of about 4 to 5 points within their group, and BFA resulted in a similar NRS pain score reduction compared with ketorolac 15 mg. Because the baseline NRS pain scores were significantly different between the BFA and ketorolac groups, a subgroup analysis revealed that BFA reduced mean NRS pain score in patients with severe and very severe pain but appears to be less beneficial for moderate pain, unlike the ketorolac results that showed a large reduction in all pain groups except for the small sample of patients with mild pain.

 

 

In this study, more patients in the BFA group presented to the ED with lower extremity pain, such as gout or neuropathy, compared with the ketorolac group; however, BFA did not result in a significantly different pain score reduction in this subgroup compared with ketorolac. Patients receiving BFA were more likely to receive topical analgesics or muscle relaxants at discharge; whereas those receiving ketorolac were significantly more likely to receive oral NSAIDs. Patients in this study also were more likely to be admitted to the hospital if they received ketorolac; however, for these patients, pain was secondary to their chief presentation, and the admitting physician’s familiarity with ketorolac might have been the reason for choosing this intervention. Reasons for the admissions were surgical observation, psychiatric stabilization, kidney/gallstones, rule out of acute coronary syndrome, pneumonia, and proctitis in the ketorolac group, and suicidal ideations in the BFA group.

Limitations

As a limited number of patients received BFA at JBVAMC, the study was not sufficiently powered to detect a difference in the primary outcome. Because BFA required a consultation to be entered in the electronic health record, in addition to time needed to perform the procedure, practitioners might have preferred IV/IM ketorolac during busy times in the ED, potentially leading to underrepresentation in the BFA group. Prescribing preferences might have differed among the rotating physicians, timing of the documentation of the NRS pain score could have differed based on the treatment intervention, and the investigators were unable to control or accurately assess whether patients had taken an analgesic medication before presenting to the ED. Because pain and the treating physician are subjective, patients who reported a higher baseline pain severity might have been more likely to be discharged with topical analgesics or muscle relaxants. One way to correct for this subjectivity would be to conduct a larger prospective trial with a single treating physician. Finally, ED encounters in this study were short, and there was no follow-up permitting identification of AEs.

Conclusions

NRS pain score reduction with BFA did not differ compared with ketorolac 15 mg for treating acute and acute-on-chronic pain in the ED. Although this study was underpowered, these results add to the limited existing literature, suggesting that both interventions could result in clinically significant pain score reductions for patients presenting to the ED with severe and very severe pain, making BFA a viable nonpharmacologic option. Future studies could include investigating the benefit of BFA in the veteran population by studying larger samples in the ED, surveying patients after their interventions to identify rates AEs, and exploring the use of BFA for chronic pain in the outpatient setting.

References

1. Cantrill SV, Brown MD, Carlisle RJ, et al. Clinical policy: critical issues in the prescribing of opioids for adult patients in the emergency department. Ann Emerg Med. 2012;60(4):499-525. doi:10.1016/j.annemergmed.2012.06.013

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Motov S, Strayer R, Hayes BD, et al. The treatment of acute pain in the emergency department: a white paper position statement prepared for the American Academy of Emergency Medicine. J Emerg Med. 2018;54(5):731-736. doi:10.1016/j.jemermed.2018.01.020

4. Samcam I, Papa L. Acute pain management in the emergency department. In: Prostran M, ed. Pain Management. IntechOpen; 2016. doi:10.5772/62861

5. Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the use of opioids in the management of chronic pain. Accessed February 15, 2023. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf

6. Davis MT, Mulvaney-Day N, Larson MJ, Hoover R, Mauch D. Complementary and alternative medicine among veterans and military personnel: a synthesis of population surveys. Med Care. 2014;52(12 suppl 5):S83-590. doi:10.1097/MLR.0000000000000227

7. Goertz C, Marriott BP, Finch FD, et al. Military report more complementary and alternative medicine use than civilians. J Altern Complement Med. 2013;19(6):509-517. doi:10.1089/acm.2012.0108

8. King HC, Hickey AH, Connelly C. Auricular acupuncture: a brief introduction for military providers. Mil Med. 2013;178(8):867-874. doi:10.7205/MILMED-D-13-00075

9. Niemtzow RC. Battlefield acupuncture. Medical Acupunct. 2007;19(4):225-228. doi:10.1089/acu.2007.0603

10. Collinsworth KM, Goss DL. Battlefield acupuncture and physical therapy versus physical therapy alone after shoulder surgery. Med Acupunct. 2019;31(4):228-238. doi:10.1089/acu.2019.1372

11. Estores I, Chen K, Jackson B, Lao L, Gorman PH. Auricular acupuncture for spinal cord injury related neuropathic pain: a pilot controlled clinical trial. J Spinal Cord Med. 2017;40(4):432-438. doi:10.1080/10790268.2016.1141489

12. Federman DG, Radhakrishnan K, Gabriel L, Poulin LM, Kravetz JD. Group battlefield acupuncture in primary care for veterans with pain. South Med J. 2018;111(10):619-624. doi:10.14423/SMJ.0000000000000877

13. Garner BK, Hopkinson SG, Ketz AK, Landis CA, Trego LL. Auricular acupuncture for chronic pain and insomnia: a randomized clinical trial. Med Acupunct. 2018;30(5):262-272. doi:10.1089/acu.2018.1294

14. Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018; 36:1045-1048. doi:10.1016/j.ajem.2018.02.038

15. Woo A, Lechner B, Fu T, et al. Cut points for mild, moderate, and severe pain among cancer and non-cancer patients: a literature review. Ann Palliat Med. 2015;4(4):176-183. doi:10.3978/j.issn.2224-5820.2015.09.04

16. Motov S, Yasavolian M, Likourezos A, et al. Comparison of intravenous ketorolac at three single-dose regimens for treating acute pain in the emergency department: a randomized controlled trial. Ann Emerg Med. 2017;70(2):177-184. doi:10.1016/j.annemergmed.2016.10.014

17. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003;10:390-392. doi:10.1111/j.1553-2712.2003.tb01355.

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Correspondence: Zane Elfessi (zane.elfessi@va.gov)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois at Chicago College of Pharmacy

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.<--pagebreak-->

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This study was approved by the Jesse Brown Veterans Affairs Medical Center Institutional Review Board in Chicago, Illinois.

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Correspondence: Zane Elfessi (zane.elfessi@va.gov)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois at Chicago College of Pharmacy

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.<--pagebreak-->

Ethics and consent

This study was approved by the Jesse Brown Veterans Affairs Medical Center Institutional Review Board in Chicago, Illinois.

Author and Disclosure Information

Eva Galka, PharmDa; Zane Elfessi, PharmD, BCPS, BCCCPa,b; Tulika Singh, MDa; Erica Liu, PharmDa; Caitlin Turnbull, PharmD, BCPSa

Correspondence: Zane Elfessi (zane.elfessi@va.gov)

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois at Chicago College of Pharmacy

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.<--pagebreak-->

Ethics and consent

This study was approved by the Jesse Brown Veterans Affairs Medical Center Institutional Review Board in Chicago, Illinois.

Article PDF
Article PDF

Acute pain is a primary symptom for many patients who present to the emergency department (ED). The ED team is challenged with relieving pain while limiting harm from medications.1 A 2017 National Health Interview Survey showed that compared with nonveterans, more veterans reported pain in the previous 3 months, and the rate of severe pain was 40% higher in the veteran group especially among those who served during the era of wars in Afghanistan and Iraq.2

The American College of Emergency Physicians guidelines pain management guidelines recommend patient-centered shared decision making that includes patient education about treatment goals and expectations, and short- and long-term risks, as well as a preference toward pharmacologic treatment with nonopioid analgesics except for patients with severe pain or pain refractory to other drug and treatment modalities.3 There is a lack of evidence regarding superior efficacy of either opioid or nonopioid analgesics; therefore, the use of nonopioid analgesics, such as oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs) or central analgesics, such as acetaminophen, is preferred for treating acute pain to mitigate adverse effects (AEs) and risks associated with opioid use.1,3,4 The US Department of Veterans Affairs (VA) and Department of Defense (DoD) guideline on managing opioid therapy for chronic pain, updated in 2017 and 2022, similarly recommends alternatives to opioids for mild-to-moderate acute pain and encourages multimodal pain care.5 However, use of other pharmacologic treatments, such as NSAIDs, is limited by AE profiles, patient contraindications, and severity of acute pain etiologies. There is a need for the expanded use of nonpharmacologic treatments for addressing pain in the veteran population.

The American College of Emergency Physicians guidelines recommend nonpharmacologic modalities, such as applying heat or cold, physical therapy, cognitive behavioral therapy, and acupuncture.3 A 2014 study reported that 37% to 46% of active duty and reserve military personnel use complementary and alternative medicine (CAM) for a variety of ailments, and there is increasing interest in the use of CAM as adjuncts to traditional therapies.6 According to one study, some CAM therapies are used significantly more by military personnel than used by civilians.7 However, the percentage of the veteran population using acupuncture in this study was small, and more information is needed to assess its use.

Auricular acupuncture originated in traditional Chinese medicine.8 Contemporary auricular acupuncture experts view this modality as a self-contained microsystem mapping portions of the ear to specific parts of the body and internal organs. The analgesic effects may be mediated through the central nervous system by local release of endorphins through nerve fiber activation and neurotransmitters—including serotonin, dopamine, and norepinephrine—leading to pre- and postsynaptic suppression of pain transmission.

Battlefield acupuncture (BFA) uses 5 set points anatomically located on each ear.9 Practitioners use small semipermanent, dartlike acupuncture needles. Patients could experience pain relief in a few minutes, which can last minutes, hours, days, weeks, or months depending on the pathology of the pain. This procedure developed in 2001 has been studied for different pain types and has shown benefit when used for postsurgical pain, chronic spinal cord injury−related neuropathic pain, and general chronic pain, as well as for other indications, such as insomnia, depression, and weight loss.8,10-13 In 2018, a randomized controlled trial compared postintervention numeric rating scale (NRS) pain scores in patients presenting to the ED with acute or acute-on-chronic lower back pain who received BFA as an adjunct to standard care vs standard care alone.14 Patients receiving BFA as an adjunct to standard care were found to have mean postintervention pain scores 1.7 points lower than those receiving standard care alone. This study demonstrated that BFA was feasible and well tolerated for lower back pain in the ED as an adjunct to standard care. The study was limited by the adjunct use of BFA rather than as monotherapy and by the practitioners’ discretion regarding standard care, which was not defined by the study’s authors.

 

 


The Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, offers several CAM modalities, such as exercise/movement therapy, chiropractic, art/music therapy, and relaxation workshops, which are widely used by veterans. Recent evidence suggests BFA could reduce pain scores as an adjunct or an alternative to pharmacologic therapy. We are interested in how CAM therapies, such as BFA, can help avoid AEs associated with opioid or NSAID therapy.

At the JBVAMC ED, ketorolac 15 mg is the preferred first-line treatment of acute, noncancer pain, based on the results of previous studies. In 2018 BFA was offered first to veterans presenting with acute or acute-on-chronic pain to the ED; however, its effectiveness for pain reduction vs ketorolac has not been evaluated in this patient population. Limited literature is available on BFA and its use in the ED. To our knowledge, this was the first observational study assessing the difference between a single session of BFA vs a single dose of ketorolac in treating noncancer acute or acute-on-chronic pain in the ED.

Methods

This study was a retrospective chart review of patients who presented to the JBVAMC ED with acute pain or acute-on-chronic pain, who received ketorolac or BFA. The study population was generated from a list of all IV and intramuscular (IM) ketorolac unit dose orders verified from June 1, 2018, through August 30, 2019, and a list of all BFA procedure notes signed from June 1, 2018, through August 30, 2019. Patients were included in the study if they had documented administration of IV or IM ketorolac or BFA between June 1, 2018, and August 30, 2019. Patients who received ketorolac doses other than 15 mg, the intervention was administered outside of the ED, received adjunct treatment in addition to the treatment intervention in the ED, had no baseline NRS pain score documented before the intervention, had an NRS pain score of < 4, had no postintervention NRS pain score documented within 6 hours, had a treatment indication other than pain, or had active cancer were excluded. As in previous JBVAMC studies, we used NRS pain score cutoffs (mild, moderate, severe, and very severe) based on Woo and colleagues’ meta-analysis and excluded scores < 4.15

Endpoints

The primary endpoint was the mean difference in NRS pain score before and after the intervention, determined by comparing the NRS pain score documented at triage to the ED with the first documented NRS pain score at least 30 minutes to 6 hours after treatment administration. The secondary endpoints included the number of patients prescribed pain medication at discharge, the number of patients who were discharged with no medications, and the number of patients admitted to the hospital. The safety endpoint included any AEs of the intervention. Subgroup analyses were performed comparing the mean difference in NRS pain score among subgroups classified by severity of baseline NRS pain score and pain location.

Statistical Analysis

Baseline characteristics and endpoints were analyzed using descriptive statistics. Categorical data were analyzed using Fisher exact test and z test for proportions, and continuous data were compared using t test and paired t test. An 80% power calculation determined that 84 patients per group were needed to detect a statistically significant difference in pain score reduction of 1.3 at a type-1 error rate of 0.05. The sample size was based on a calculation performed in a previously published study that compared IV ketorolac at 3 single-dose regimens for treating acute pain in the ED.16 The 1.3 pain score reduction is considered the minimum clinically significant difference in pain that could be detected with the NRS.17

 

 

Results

Sixty-one patients received BFA during the study period: 31 were excluded (26 received adjunct treatment in the ED, 2 had active cancer documented, 2 had an indication other than pain, and 1 received BFA outside of the ED), leaving 30 patients in the BFA cohort. During the study period, 1299 patients received ketorolac. These patients were selected using a random number generator and then screened to determine inclusion or exclusion in the study. We continued to randomly select patients for the ketorolac group until we had a similar number in each treatment group. Of these 148 patients who were randomly selected to be reviewed, 116 were excluded: 48 received adjunct treatment in the ED, 24 had no postintervention NRS pain score documented within 6 hours, 18 received ketorolac doses other than 15 mg, 12 received ketorolac outside the ED, 9 had no baseline NRS pain score documented, 3 presented with a NRS pain score of ≤ 3, and 2 had active cancer documented. The ketorolac cohort comprised 31 patients.

Baseline characteristics were similar between the 2 groups except for the average baseline NRS pain score, which was statistically significantly higher in the BFA vs ketorolac group (8.7 vs 7.7, respectively; P = .02). The mean age was 51 years in the BFA group and 48 years in the ketorolac group. Most patients in each cohort were male: 80% in the BFA group and 71% in the ketorolac group. The most common types of pain documented as the chief ED presentation included back, lower extremity, and head.

table_1.png
Ten patients in the BFA group and 3 in the ketorolac group presented with lower extremity pain (P = .02) (Table 1).

Endpoints

The mean difference in NRS pain score was 3.9 for the BFA group and 5.1 for the ketorolac group. Both were clinically and statistically significant reductions (P = .03 and P < .01), but the difference between the intervention groups in NRS score reduction was not statistically significant (P = .07).

For the secondary endpoint of outpatient prescriptions written at discharge, there was no significant difference between the groups except for oral NSAIDs, which were more likely to be prescribed to patients who received ketorolac (P = .01).

table_2.png
Patients who received BFA were more likely to receive oral muscle relaxants or topical analgesics, but the difference between the groups was not statistically significant (Table 2). There was no difference in the number of patients who received no prescriptions at ED discharge. Patients who received ketorolac were more likely to be admitted to the hospital (P = .049) (Table 3).
table_3.png
 No AEs were observed in either treatment group during the study.

Subgroup Analysis

An analysis was performed for subgroups classified by baseline NRS pain score (mild: 4; moderate, 5 - 6; severe, 7 - 9; and very severe, 10). Data for mild pain was limited because a small number of patients received interventions. For moderate pain, the mean difference in NRS pain score for BFA and ketorolac was 3.5 and 3.8, respectively; for severe pain, 3.4 and 5.3; and for very severe pain, 4.6 and 6.4. There was a larger difference in the preintervention and postintervention NRS pain scores within severe pain and very severe pain groups.

figure.png
The mean difference in NRS pain score reduction between the intervention groups was not statistically significant for any subgroup (Figure).
table_4.png
A subgroup analysis also was performed comparing pain locations, although no statistically significant difference was found among the subgroups (Table 4).

Discussion

Both interventions resulted in a significant reduction in the mean NRS pain score of about 4 to 5 points within their group, and BFA resulted in a similar NRS pain score reduction compared with ketorolac 15 mg. Because the baseline NRS pain scores were significantly different between the BFA and ketorolac groups, a subgroup analysis revealed that BFA reduced mean NRS pain score in patients with severe and very severe pain but appears to be less beneficial for moderate pain, unlike the ketorolac results that showed a large reduction in all pain groups except for the small sample of patients with mild pain.

 

 

In this study, more patients in the BFA group presented to the ED with lower extremity pain, such as gout or neuropathy, compared with the ketorolac group; however, BFA did not result in a significantly different pain score reduction in this subgroup compared with ketorolac. Patients receiving BFA were more likely to receive topical analgesics or muscle relaxants at discharge; whereas those receiving ketorolac were significantly more likely to receive oral NSAIDs. Patients in this study also were more likely to be admitted to the hospital if they received ketorolac; however, for these patients, pain was secondary to their chief presentation, and the admitting physician’s familiarity with ketorolac might have been the reason for choosing this intervention. Reasons for the admissions were surgical observation, psychiatric stabilization, kidney/gallstones, rule out of acute coronary syndrome, pneumonia, and proctitis in the ketorolac group, and suicidal ideations in the BFA group.

Limitations

As a limited number of patients received BFA at JBVAMC, the study was not sufficiently powered to detect a difference in the primary outcome. Because BFA required a consultation to be entered in the electronic health record, in addition to time needed to perform the procedure, practitioners might have preferred IV/IM ketorolac during busy times in the ED, potentially leading to underrepresentation in the BFA group. Prescribing preferences might have differed among the rotating physicians, timing of the documentation of the NRS pain score could have differed based on the treatment intervention, and the investigators were unable to control or accurately assess whether patients had taken an analgesic medication before presenting to the ED. Because pain and the treating physician are subjective, patients who reported a higher baseline pain severity might have been more likely to be discharged with topical analgesics or muscle relaxants. One way to correct for this subjectivity would be to conduct a larger prospective trial with a single treating physician. Finally, ED encounters in this study were short, and there was no follow-up permitting identification of AEs.

Conclusions

NRS pain score reduction with BFA did not differ compared with ketorolac 15 mg for treating acute and acute-on-chronic pain in the ED. Although this study was underpowered, these results add to the limited existing literature, suggesting that both interventions could result in clinically significant pain score reductions for patients presenting to the ED with severe and very severe pain, making BFA a viable nonpharmacologic option. Future studies could include investigating the benefit of BFA in the veteran population by studying larger samples in the ED, surveying patients after their interventions to identify rates AEs, and exploring the use of BFA for chronic pain in the outpatient setting.

Acute pain is a primary symptom for many patients who present to the emergency department (ED). The ED team is challenged with relieving pain while limiting harm from medications.1 A 2017 National Health Interview Survey showed that compared with nonveterans, more veterans reported pain in the previous 3 months, and the rate of severe pain was 40% higher in the veteran group especially among those who served during the era of wars in Afghanistan and Iraq.2

The American College of Emergency Physicians guidelines pain management guidelines recommend patient-centered shared decision making that includes patient education about treatment goals and expectations, and short- and long-term risks, as well as a preference toward pharmacologic treatment with nonopioid analgesics except for patients with severe pain or pain refractory to other drug and treatment modalities.3 There is a lack of evidence regarding superior efficacy of either opioid or nonopioid analgesics; therefore, the use of nonopioid analgesics, such as oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs) or central analgesics, such as acetaminophen, is preferred for treating acute pain to mitigate adverse effects (AEs) and risks associated with opioid use.1,3,4 The US Department of Veterans Affairs (VA) and Department of Defense (DoD) guideline on managing opioid therapy for chronic pain, updated in 2017 and 2022, similarly recommends alternatives to opioids for mild-to-moderate acute pain and encourages multimodal pain care.5 However, use of other pharmacologic treatments, such as NSAIDs, is limited by AE profiles, patient contraindications, and severity of acute pain etiologies. There is a need for the expanded use of nonpharmacologic treatments for addressing pain in the veteran population.

The American College of Emergency Physicians guidelines recommend nonpharmacologic modalities, such as applying heat or cold, physical therapy, cognitive behavioral therapy, and acupuncture.3 A 2014 study reported that 37% to 46% of active duty and reserve military personnel use complementary and alternative medicine (CAM) for a variety of ailments, and there is increasing interest in the use of CAM as adjuncts to traditional therapies.6 According to one study, some CAM therapies are used significantly more by military personnel than used by civilians.7 However, the percentage of the veteran population using acupuncture in this study was small, and more information is needed to assess its use.

Auricular acupuncture originated in traditional Chinese medicine.8 Contemporary auricular acupuncture experts view this modality as a self-contained microsystem mapping portions of the ear to specific parts of the body and internal organs. The analgesic effects may be mediated through the central nervous system by local release of endorphins through nerve fiber activation and neurotransmitters—including serotonin, dopamine, and norepinephrine—leading to pre- and postsynaptic suppression of pain transmission.

Battlefield acupuncture (BFA) uses 5 set points anatomically located on each ear.9 Practitioners use small semipermanent, dartlike acupuncture needles. Patients could experience pain relief in a few minutes, which can last minutes, hours, days, weeks, or months depending on the pathology of the pain. This procedure developed in 2001 has been studied for different pain types and has shown benefit when used for postsurgical pain, chronic spinal cord injury−related neuropathic pain, and general chronic pain, as well as for other indications, such as insomnia, depression, and weight loss.8,10-13 In 2018, a randomized controlled trial compared postintervention numeric rating scale (NRS) pain scores in patients presenting to the ED with acute or acute-on-chronic lower back pain who received BFA as an adjunct to standard care vs standard care alone.14 Patients receiving BFA as an adjunct to standard care were found to have mean postintervention pain scores 1.7 points lower than those receiving standard care alone. This study demonstrated that BFA was feasible and well tolerated for lower back pain in the ED as an adjunct to standard care. The study was limited by the adjunct use of BFA rather than as monotherapy and by the practitioners’ discretion regarding standard care, which was not defined by the study’s authors.

 

 


The Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, offers several CAM modalities, such as exercise/movement therapy, chiropractic, art/music therapy, and relaxation workshops, which are widely used by veterans. Recent evidence suggests BFA could reduce pain scores as an adjunct or an alternative to pharmacologic therapy. We are interested in how CAM therapies, such as BFA, can help avoid AEs associated with opioid or NSAID therapy.

At the JBVAMC ED, ketorolac 15 mg is the preferred first-line treatment of acute, noncancer pain, based on the results of previous studies. In 2018 BFA was offered first to veterans presenting with acute or acute-on-chronic pain to the ED; however, its effectiveness for pain reduction vs ketorolac has not been evaluated in this patient population. Limited literature is available on BFA and its use in the ED. To our knowledge, this was the first observational study assessing the difference between a single session of BFA vs a single dose of ketorolac in treating noncancer acute or acute-on-chronic pain in the ED.

Methods

This study was a retrospective chart review of patients who presented to the JBVAMC ED with acute pain or acute-on-chronic pain, who received ketorolac or BFA. The study population was generated from a list of all IV and intramuscular (IM) ketorolac unit dose orders verified from June 1, 2018, through August 30, 2019, and a list of all BFA procedure notes signed from June 1, 2018, through August 30, 2019. Patients were included in the study if they had documented administration of IV or IM ketorolac or BFA between June 1, 2018, and August 30, 2019. Patients who received ketorolac doses other than 15 mg, the intervention was administered outside of the ED, received adjunct treatment in addition to the treatment intervention in the ED, had no baseline NRS pain score documented before the intervention, had an NRS pain score of < 4, had no postintervention NRS pain score documented within 6 hours, had a treatment indication other than pain, or had active cancer were excluded. As in previous JBVAMC studies, we used NRS pain score cutoffs (mild, moderate, severe, and very severe) based on Woo and colleagues’ meta-analysis and excluded scores < 4.15

Endpoints

The primary endpoint was the mean difference in NRS pain score before and after the intervention, determined by comparing the NRS pain score documented at triage to the ED with the first documented NRS pain score at least 30 minutes to 6 hours after treatment administration. The secondary endpoints included the number of patients prescribed pain medication at discharge, the number of patients who were discharged with no medications, and the number of patients admitted to the hospital. The safety endpoint included any AEs of the intervention. Subgroup analyses were performed comparing the mean difference in NRS pain score among subgroups classified by severity of baseline NRS pain score and pain location.

Statistical Analysis

Baseline characteristics and endpoints were analyzed using descriptive statistics. Categorical data were analyzed using Fisher exact test and z test for proportions, and continuous data were compared using t test and paired t test. An 80% power calculation determined that 84 patients per group were needed to detect a statistically significant difference in pain score reduction of 1.3 at a type-1 error rate of 0.05. The sample size was based on a calculation performed in a previously published study that compared IV ketorolac at 3 single-dose regimens for treating acute pain in the ED.16 The 1.3 pain score reduction is considered the minimum clinically significant difference in pain that could be detected with the NRS.17

 

 

Results

Sixty-one patients received BFA during the study period: 31 were excluded (26 received adjunct treatment in the ED, 2 had active cancer documented, 2 had an indication other than pain, and 1 received BFA outside of the ED), leaving 30 patients in the BFA cohort. During the study period, 1299 patients received ketorolac. These patients were selected using a random number generator and then screened to determine inclusion or exclusion in the study. We continued to randomly select patients for the ketorolac group until we had a similar number in each treatment group. Of these 148 patients who were randomly selected to be reviewed, 116 were excluded: 48 received adjunct treatment in the ED, 24 had no postintervention NRS pain score documented within 6 hours, 18 received ketorolac doses other than 15 mg, 12 received ketorolac outside the ED, 9 had no baseline NRS pain score documented, 3 presented with a NRS pain score of ≤ 3, and 2 had active cancer documented. The ketorolac cohort comprised 31 patients.

Baseline characteristics were similar between the 2 groups except for the average baseline NRS pain score, which was statistically significantly higher in the BFA vs ketorolac group (8.7 vs 7.7, respectively; P = .02). The mean age was 51 years in the BFA group and 48 years in the ketorolac group. Most patients in each cohort were male: 80% in the BFA group and 71% in the ketorolac group. The most common types of pain documented as the chief ED presentation included back, lower extremity, and head.

table_1.png
Ten patients in the BFA group and 3 in the ketorolac group presented with lower extremity pain (P = .02) (Table 1).

Endpoints

The mean difference in NRS pain score was 3.9 for the BFA group and 5.1 for the ketorolac group. Both were clinically and statistically significant reductions (P = .03 and P < .01), but the difference between the intervention groups in NRS score reduction was not statistically significant (P = .07).

For the secondary endpoint of outpatient prescriptions written at discharge, there was no significant difference between the groups except for oral NSAIDs, which were more likely to be prescribed to patients who received ketorolac (P = .01).

table_2.png
Patients who received BFA were more likely to receive oral muscle relaxants or topical analgesics, but the difference between the groups was not statistically significant (Table 2). There was no difference in the number of patients who received no prescriptions at ED discharge. Patients who received ketorolac were more likely to be admitted to the hospital (P = .049) (Table 3).
table_3.png
 No AEs were observed in either treatment group during the study.

Subgroup Analysis

An analysis was performed for subgroups classified by baseline NRS pain score (mild: 4; moderate, 5 - 6; severe, 7 - 9; and very severe, 10). Data for mild pain was limited because a small number of patients received interventions. For moderate pain, the mean difference in NRS pain score for BFA and ketorolac was 3.5 and 3.8, respectively; for severe pain, 3.4 and 5.3; and for very severe pain, 4.6 and 6.4. There was a larger difference in the preintervention and postintervention NRS pain scores within severe pain and very severe pain groups.

figure.png
The mean difference in NRS pain score reduction between the intervention groups was not statistically significant for any subgroup (Figure).
table_4.png
A subgroup analysis also was performed comparing pain locations, although no statistically significant difference was found among the subgroups (Table 4).

Discussion

Both interventions resulted in a significant reduction in the mean NRS pain score of about 4 to 5 points within their group, and BFA resulted in a similar NRS pain score reduction compared with ketorolac 15 mg. Because the baseline NRS pain scores were significantly different between the BFA and ketorolac groups, a subgroup analysis revealed that BFA reduced mean NRS pain score in patients with severe and very severe pain but appears to be less beneficial for moderate pain, unlike the ketorolac results that showed a large reduction in all pain groups except for the small sample of patients with mild pain.

 

 

In this study, more patients in the BFA group presented to the ED with lower extremity pain, such as gout or neuropathy, compared with the ketorolac group; however, BFA did not result in a significantly different pain score reduction in this subgroup compared with ketorolac. Patients receiving BFA were more likely to receive topical analgesics or muscle relaxants at discharge; whereas those receiving ketorolac were significantly more likely to receive oral NSAIDs. Patients in this study also were more likely to be admitted to the hospital if they received ketorolac; however, for these patients, pain was secondary to their chief presentation, and the admitting physician’s familiarity with ketorolac might have been the reason for choosing this intervention. Reasons for the admissions were surgical observation, psychiatric stabilization, kidney/gallstones, rule out of acute coronary syndrome, pneumonia, and proctitis in the ketorolac group, and suicidal ideations in the BFA group.

Limitations

As a limited number of patients received BFA at JBVAMC, the study was not sufficiently powered to detect a difference in the primary outcome. Because BFA required a consultation to be entered in the electronic health record, in addition to time needed to perform the procedure, practitioners might have preferred IV/IM ketorolac during busy times in the ED, potentially leading to underrepresentation in the BFA group. Prescribing preferences might have differed among the rotating physicians, timing of the documentation of the NRS pain score could have differed based on the treatment intervention, and the investigators were unable to control or accurately assess whether patients had taken an analgesic medication before presenting to the ED. Because pain and the treating physician are subjective, patients who reported a higher baseline pain severity might have been more likely to be discharged with topical analgesics or muscle relaxants. One way to correct for this subjectivity would be to conduct a larger prospective trial with a single treating physician. Finally, ED encounters in this study were short, and there was no follow-up permitting identification of AEs.

Conclusions

NRS pain score reduction with BFA did not differ compared with ketorolac 15 mg for treating acute and acute-on-chronic pain in the ED. Although this study was underpowered, these results add to the limited existing literature, suggesting that both interventions could result in clinically significant pain score reductions for patients presenting to the ED with severe and very severe pain, making BFA a viable nonpharmacologic option. Future studies could include investigating the benefit of BFA in the veteran population by studying larger samples in the ED, surveying patients after their interventions to identify rates AEs, and exploring the use of BFA for chronic pain in the outpatient setting.

References

1. Cantrill SV, Brown MD, Carlisle RJ, et al. Clinical policy: critical issues in the prescribing of opioids for adult patients in the emergency department. Ann Emerg Med. 2012;60(4):499-525. doi:10.1016/j.annemergmed.2012.06.013

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Motov S, Strayer R, Hayes BD, et al. The treatment of acute pain in the emergency department: a white paper position statement prepared for the American Academy of Emergency Medicine. J Emerg Med. 2018;54(5):731-736. doi:10.1016/j.jemermed.2018.01.020

4. Samcam I, Papa L. Acute pain management in the emergency department. In: Prostran M, ed. Pain Management. IntechOpen; 2016. doi:10.5772/62861

5. Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the use of opioids in the management of chronic pain. Accessed February 15, 2023. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf

6. Davis MT, Mulvaney-Day N, Larson MJ, Hoover R, Mauch D. Complementary and alternative medicine among veterans and military personnel: a synthesis of population surveys. Med Care. 2014;52(12 suppl 5):S83-590. doi:10.1097/MLR.0000000000000227

7. Goertz C, Marriott BP, Finch FD, et al. Military report more complementary and alternative medicine use than civilians. J Altern Complement Med. 2013;19(6):509-517. doi:10.1089/acm.2012.0108

8. King HC, Hickey AH, Connelly C. Auricular acupuncture: a brief introduction for military providers. Mil Med. 2013;178(8):867-874. doi:10.7205/MILMED-D-13-00075

9. Niemtzow RC. Battlefield acupuncture. Medical Acupunct. 2007;19(4):225-228. doi:10.1089/acu.2007.0603

10. Collinsworth KM, Goss DL. Battlefield acupuncture and physical therapy versus physical therapy alone after shoulder surgery. Med Acupunct. 2019;31(4):228-238. doi:10.1089/acu.2019.1372

11. Estores I, Chen K, Jackson B, Lao L, Gorman PH. Auricular acupuncture for spinal cord injury related neuropathic pain: a pilot controlled clinical trial. J Spinal Cord Med. 2017;40(4):432-438. doi:10.1080/10790268.2016.1141489

12. Federman DG, Radhakrishnan K, Gabriel L, Poulin LM, Kravetz JD. Group battlefield acupuncture in primary care for veterans with pain. South Med J. 2018;111(10):619-624. doi:10.14423/SMJ.0000000000000877

13. Garner BK, Hopkinson SG, Ketz AK, Landis CA, Trego LL. Auricular acupuncture for chronic pain and insomnia: a randomized clinical trial. Med Acupunct. 2018;30(5):262-272. doi:10.1089/acu.2018.1294

14. Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018; 36:1045-1048. doi:10.1016/j.ajem.2018.02.038

15. Woo A, Lechner B, Fu T, et al. Cut points for mild, moderate, and severe pain among cancer and non-cancer patients: a literature review. Ann Palliat Med. 2015;4(4):176-183. doi:10.3978/j.issn.2224-5820.2015.09.04

16. Motov S, Yasavolian M, Likourezos A, et al. Comparison of intravenous ketorolac at three single-dose regimens for treating acute pain in the emergency department: a randomized controlled trial. Ann Emerg Med. 2017;70(2):177-184. doi:10.1016/j.annemergmed.2016.10.014

17. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003;10:390-392. doi:10.1111/j.1553-2712.2003.tb01355.

References

1. Cantrill SV, Brown MD, Carlisle RJ, et al. Clinical policy: critical issues in the prescribing of opioids for adult patients in the emergency department. Ann Emerg Med. 2012;60(4):499-525. doi:10.1016/j.annemergmed.2012.06.013

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Motov S, Strayer R, Hayes BD, et al. The treatment of acute pain in the emergency department: a white paper position statement prepared for the American Academy of Emergency Medicine. J Emerg Med. 2018;54(5):731-736. doi:10.1016/j.jemermed.2018.01.020

4. Samcam I, Papa L. Acute pain management in the emergency department. In: Prostran M, ed. Pain Management. IntechOpen; 2016. doi:10.5772/62861

5. Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the use of opioids in the management of chronic pain. Accessed February 15, 2023. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf

6. Davis MT, Mulvaney-Day N, Larson MJ, Hoover R, Mauch D. Complementary and alternative medicine among veterans and military personnel: a synthesis of population surveys. Med Care. 2014;52(12 suppl 5):S83-590. doi:10.1097/MLR.0000000000000227

7. Goertz C, Marriott BP, Finch FD, et al. Military report more complementary and alternative medicine use than civilians. J Altern Complement Med. 2013;19(6):509-517. doi:10.1089/acm.2012.0108

8. King HC, Hickey AH, Connelly C. Auricular acupuncture: a brief introduction for military providers. Mil Med. 2013;178(8):867-874. doi:10.7205/MILMED-D-13-00075

9. Niemtzow RC. Battlefield acupuncture. Medical Acupunct. 2007;19(4):225-228. doi:10.1089/acu.2007.0603

10. Collinsworth KM, Goss DL. Battlefield acupuncture and physical therapy versus physical therapy alone after shoulder surgery. Med Acupunct. 2019;31(4):228-238. doi:10.1089/acu.2019.1372

11. Estores I, Chen K, Jackson B, Lao L, Gorman PH. Auricular acupuncture for spinal cord injury related neuropathic pain: a pilot controlled clinical trial. J Spinal Cord Med. 2017;40(4):432-438. doi:10.1080/10790268.2016.1141489

12. Federman DG, Radhakrishnan K, Gabriel L, Poulin LM, Kravetz JD. Group battlefield acupuncture in primary care for veterans with pain. South Med J. 2018;111(10):619-624. doi:10.14423/SMJ.0000000000000877

13. Garner BK, Hopkinson SG, Ketz AK, Landis CA, Trego LL. Auricular acupuncture for chronic pain and insomnia: a randomized clinical trial. Med Acupunct. 2018;30(5):262-272. doi:10.1089/acu.2018.1294

14. Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. Am J Emerg Med. 2018; 36:1045-1048. doi:10.1016/j.ajem.2018.02.038

15. Woo A, Lechner B, Fu T, et al. Cut points for mild, moderate, and severe pain among cancer and non-cancer patients: a literature review. Ann Palliat Med. 2015;4(4):176-183. doi:10.3978/j.issn.2224-5820.2015.09.04

16. Motov S, Yasavolian M, Likourezos A, et al. Comparison of intravenous ketorolac at three single-dose regimens for treating acute pain in the emergency department: a randomized controlled trial. Ann Emerg Med. 2017;70(2):177-184. doi:10.1016/j.annemergmed.2016.10.014

17. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003;10:390-392. doi:10.1111/j.1553-2712.2003.tb01355.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0423 FED Pain Treatment</fileName> <TBEID>0C02C545.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02C545</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname>0423 FED Pain Treatment</storyname> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20230410T162620</firstPublished> <LastPublished>20230410T162620</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20230410T162620</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Eva Galka, PharmDa; Zane Elfessi, PharmD, BCPS, BCCCPa,b; Tulika Singh, MDa; Erica Liu, PharmDa; Caitlin Turnbull, PharmD, BCPSa</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Acute pain is a primary symptom for many patients who present to the emergency department (ED). The ED team is challenged with relieving pain while limiting har</metaDescription> <articlePDF/> <teaserImage/> <title>Battlefield Acupuncture vs Ketorolac for Treating Pain in the Emergency Department</title> <deck/> <eyebrow>Original Research</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2023</pubPubdateYear> <pubPubdateMonth>April</pubPubdateMonth> <pubPubdateDay/> <pubVolume>40</pubVolume> <pubNumber>4</pubNumber> <wireChannels/> <primaryCMSID>2951</primaryCMSID> <CMSIDs> <CMSID>2951</CMSID> <CMSID>2849</CMSID> <CMSID>2885</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>April 2023</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics> <pubTopic>Alternative Therapies | 2849</pubTopic> <pubTopic>Pain | 2885</pubTopic> </pubTopics> <pubCategories/> <pubSections> <pubSection>Feature | 2951<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">104</term> </sections> <topics> <term canonical="true">268</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Battlefield Acupuncture vs Ketorolac for Treating Pain in the Emergency Department</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> Many patients arrive in the emergency department (ED) with acute pain. Battlefield acupuncture (BFA) uses small, semipermanent acupuncture needles in 5 set points anatomically located on each ear to reduce pain in a few minutes. Pain relief can last months, depending on the pathology of the pain. At the Jesse Brown Veterans Affairs Medical Center (JBVAMC) ED, ketorolac 15 mg is the preferred first-line treatment of acute, noncancer pain. In 2018, BFA was offered first to veterans presenting with acute or acute-on-chronic pain to the ED; however, its effectiveness in pain reduction vs ketorolac has not been evaluated in this patient population. The objective of this study was to determine whether BFA monotherapy was noninferior to ketorolac 15 mg for reducing pain scores in the ED.<b>Methods: </b>This study was a retrospective, electronic chart review of patients who presented to JBVAMC ED with acute pain or acute-on-chronic pain and received ketorolac or BFA. The primary endpoint was the mean difference in the numeric rating scale (NRS) pain score from baseline. Secondary endpoints included the number of patients receiving pain medications, including topical analgesics, at discharge and treatment-related adverse events in the ED.<br/><br/><b>Results:</b> A total of 61 patients were included in the study. Baseline characteristics were similar between the 2 groups except for the average baseline NRS pain score, which was higher in the BFA group (8.7 vs 7.7; <i>P</i> = .02). The mean difference in NRS pain scores from baseline to postintervention was 3.9 for the BFA group and 5.1 for the ketorolac group. The difference in reducing the NRS pain score between the intervention groups was not statistically significant. No adverse events were observed in either treatment group.<br/><br/><b>Conclusion</b><b>s</b><b>:</b> For treating acute and acute-on-chronic pain in the ED, BFA did not differ compared with ketorolac 15 mg in NRS pain score reduction. This study’s results add to the limited existing literature suggesting that both interventions could result in clinically significant reductions in pain scores for patients presenting to the ED with severe and very severe pain, indicating BFA could be a viable nonpharmacologic treatment option.</p> <p><span class="Drop">A</span>cute pain is a primary symptom for many patients who present to the emergency department (ED). The ED team is challenged with relieving pain while limiting harm from medications.<sup>1</sup> A 2017 National Health Interview Survey showed that compared with nonveterans, more veterans reported pain in the previous 3 months, and the rate of severe pain was 40% higher in the veteran group especially among those who served during the era of wars in Afghanistan and Iraq.<sup>2</sup></p> <p>The American College of Emergency Physicians guidelines pain management guidelines recommend patient-centered shared decision making that includes patient education about treatment goals and expectations, and short- and long-term risks, as well as a preference toward pharmacologic treatment with nonopioid analgesics except for patients with severe pain or pain refractory to other drug and treatment modalities.<sup>3</sup> There is a lack of evidence regarding superior efficacy of either opioid or nonopioid analgesics; therefore, the use of nonopioid analgesics, such as oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs) or central analgesics, such as acetaminophen, is preferred for treating acute pain to mitigate adverse effects (AEs) and risks associated with opioid use.<sup>1,3,4</sup> The US Department of Veterans Affairs (VA) and Department of Defense (DoD) guideline on managing opioid therapy for chronic pain, updated in 2017 and 2022, similarly recommends alternatives to opioids for mild-to-moderate acute pain and encourages multimodal pain care.<sup>5</sup> However, use of other pharmacologic treatments, such as NSAIDs, is limited by AE profiles, patient contraindications, and severity of acute pain etiologies. There is a need for the expanded use of nonpharmacologic treatments for addressing pain in the veteran population.<br/><br/>The American College of Emergency Physicians guidelines recommend nonpharmacologic modalities, such as applying heat or cold, physical therapy, cognitive behavioral therapy, and acupuncture.<sup>3</sup> A 2014 study reported that 37% to 46% of active duty and reserve military personnel use complementary and alternative medicine (CAM) for a variety of ailments, and there is increasing interest in the use of CAM as adjuncts to traditional therapies.<sup>6</sup> According to one study, some CAM therapies are used significantly more by military personnel than used by civilians.<sup>7</sup> However, the percentage of the veteran population using acupuncture in this study was small, and more information is needed to assess its use.<br/><br/>Auricular acupuncture originated in traditional Chinese medicine.<sup>8</sup> Contemporary auricular acupuncture experts view this modality as a self-contained microsystem mapping portions of the ear to specific parts of the body and internal organs. The analgesic effects may be mediated through the central nervous system by local release of endorphins through nerve fiber activation and neurotransmitters—including serotonin, dopamine, and norepinephrine—leading to pre- and postsynaptic suppression of pain transmission.<br/><br/>Battlefield acupuncture (BFA) uses 5 set points anatomically located on each ear.<sup>9</sup> Practitioners use small semipermanent, dartlike acupuncture needles. Patients could experience pain relief in a few minutes, which can last minutes, hours, days, weeks, or months depending on the pathology of the pain. This procedure developed in 2001 has been studied for different pain types and has shown benefit when used for postsurgical pain, chronic spinal cord injury−related neuropathic pain, and general chronic pain, as well as for other indications, such as insomnia, depression, and weight loss.<sup>8,10-13</sup> In 2018, a randomized controlled trial compared postintervention numeric rating scale (NRS) pain scores in patients presenting to the ED with acute or acute-on-chronic lower back pain who received BFA as an adjunct to standard care vs standard care alone.<sup>14</sup> Patients receiving BFA as an adjunct to standard care were found to have mean postintervention pain scores 1.7 points lower than those receiving standard care alone. This study demonstrated that BFA was feasible and well tolerated for lower back pain in the ED as an adjunct to standard care. The study was limited by the adjunct use of BFA rather than as monotherapy and by the practitioners’ discretion regarding standard care, which was not defined by the study’s authors.<br/><br/>The Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, offers several CAM modalities, such as exercise/movement therapy, chiropractic, art/music therapy, and relaxation workshops, which are widely used by veterans. Recent evidence suggests BFA could reduce pain scores as an adjunct or an alternative to pharmacologic therapy. We are interested in how CAM therapies, such as BFA, can help avoid AEs associated with opioid or NSAID therapy.At the JBVAMC ED, ketorolac 15 mg is the preferred first-line treatment of acute, noncancer pain, based on the results of previous studies. In 2018 BFA was offered first to veterans presenting with acute or acute-on-chronic pain to the ED; however, its effectiveness for pain reduction vs ketorolac has not been evaluated in this patient population. Limited literature is available on BFA and its use in the ED. To our knowledge, this was the first observational study assessing the difference between a single session of BFA vs a single dose of ketorolac in treating noncancer acute or acute-on-chronic pain in the ED.</p> <h2>Methods</h2> <p>This study was a retrospective chart review of patients who presented to the JBVAMC ED with acute pain or acute-on-chronic pain, who received ketorolac or BFA. The study population was generated from a list of all IV and intramuscular (IM) ketorolac unit dose orders verified from June 1, 2018, through August 30, 2019, and a list of all BFA procedure notes signed from June 1, 2018, through August 30, 2019. Patients were included in the study if they had documented administration of IV or IM ketorolac or BFA between June 1, 2018, and August 30, 2019. Patients who received ketorolac doses other than 15 mg, the intervention was administered outside of the ED, received adjunct treatment in addition to the treatment intervention in the ED, had no baseline NRS pain score documented before the intervention, had an NRS pain score of &lt; 4, had no postintervention NRS pain score documented within 6 hours, had a treatment indication other than pain, or had active cancer were excluded. As in previous JBVAMC studies, we used NRS pain score cutoffs (mild, moderate, severe, and very severe) based on Woo and colleagues’ meta-analysis and excluded scores &lt; 4.<sup>15</sup></p> <h3>Endpoints</h3> <p>The primary endpoint was the mean difference in NRS pain score before and after the intervention, determined by comparing the NRS pain score documented at triage to the ED with the first documented NRS pain score at least 30 minutes to 6 hours after treatment administration. The secondary endpoints included the number of patients prescribed pain medication at discharge, the number of patients who were discharged with no medications, and the number of patients admitted to the hospital. The safety endpoint included any AEs of the intervention. Subgroup analyses were performed comparing the mean difference in NRS pain score among subgroups classified by severity of baseline NRS pain score and pain location.</p> <h3>Statistical Analysis</h3> <p>Baseline characteristics and endpoints were analyzed using descriptive statistics. Categorical data were analyzed using Fisher exact test and <i>z</i> test for proportions, and continuous data were compared using <i>t </i>test and paired <i>t</i> test. An 80% power calculation determined that 84 patients per group were needed to detect a statistically significant difference in pain score reduction of 1.3 at a type-1 error rate of 0.05. The sample size was based on a calculation performed in a previously published study that compared IV ketorolac at 3 single-dose regimens for treating acute pain in the ED.<sup>16</sup> The 1.3 pain score reduction is considered the minimum clinically significant difference in pain that could be detected with the NRS.<sup>17</sup></p> <h2>Results </h2> <p>Sixty-one patients received BFA during the study period: 31 were excluded (26 received adjunct treatment in the ED, 2 had active cancer documented, 2 had an indication other than pain, and 1 received BFA outside of the ED), leaving 30 patients in the BFA cohort. During the study period, 1299 patients received ketorolac. <hl name="33572"/>These patients were selected using a random number generator and then screened to determine inclusion or exclusion in the study. We continued to randomly select patients for the ketorolac group until we had a similar number in each treatment group. Of these 148 patients who were randomly selected to be reviewed, 116 were excluded: 48 received adjunct treatment in the ED, 24 had no postintervention NRS pain score documented within 6 hours, 18 received ketorolac doses other than 15 mg, 12 received ketorolac outside the ED, 9 had no baseline NRS pain score documented, 3 presented with a NRS pain score of ≤ 3, and 2 had active cancer documented. The ketorolac cohort comprised 31 patients.</p> <p>Baseline characteristics were similar between the 2 groups except for the average baseline NRS pain score, which was statistically significantly higher in the BFA vs ketorolac group (8.7 vs 7.7, respectively; <i>P</i> = .02). The mean age was 51 years in the BFA group and 48 years in the ketorolac group. Most patients in each cohort were male: 80% in the BFA group and 71% in the ketorolac group. The most common types of pain documented as the chief ED presentation included back, lower extremity, and head. Ten patients in the BFA group and 3 in the ketorolac group presented with lower extremity pain (<i>P</i> = .02) (Table 1).</p> <h3>Endpoints</h3> <p>The mean difference in NRS pain score was 3.9 for the BFA group and 5.1 for the ketorolac group. Both were clinically and statistically significant reductions (<i>P</i> = .03 and <i>P</i> &lt; .01), but the difference between the intervention groups in NRS score reduction was not statistically significant (<i>P</i> = .07).</p> <p>For the secondary endpoint of outpatient prescriptions written at discharge, there was no significant difference between the groups except for oral NSAIDs, which were more likely to be prescribed to patients who received ketorolac (<i>P</i> = .01). Patients who received BFA were more likely to receive oral muscle relaxants or topical analgesics, but the difference between the groups was not statistically significant (Table 2). There was no difference in the number of patients who received no prescriptions at ED discharge. Patients who received ketorolac were more likely to be admitted to the hospital (<i>P</i> = .049) (Table 3). No AEs were observed in either treatment group during the study.</p> <h3>Subgroup Analysis</h3> <p>An analysis was performed for subgroups classified by baseline NRS pain score (mild: 4; moderate, 5 - 6; severe, 7 - 9; and very severe, 10). Data for mild pain was limited because a small number of patients received interventions. For moderate pain, the mean difference in NRS pain score for BFA and ketorolac was 3.5 and 3.8, respectively; for severe pain, 3.4 and 5.3; and for very severe pain, 4.6 and 6.4. There was a larger difference in the preintervention and postintervention NRS pain scores within severe pain and very severe pain groups. The mean difference in NRS pain score reduction between the intervention groups was not statistically significant for any subgroup (Figure). A subgroup analysis also was performed comparing pain locations, although no statistically significant difference was found among the subgroups (Table 4).</p> <h2>Discussion </h2> <p>Both interventions resulted in a significant reduction in the mean NRS pain score of about 4 to 5 points within their group, and BFA resulted in a similar NRS pain score reduction compared with ketorolac 15 mg. Because the baseline NRS pain scores were significantly different between the BFA and ketorolac groups, <hl name="33573"/>a subgroup analysis revealed that BFA reduced mean NRS pain score in patients with severe and very severe pain but appears to be less beneficial for moderate pain, unlike the ketorolac results that showed a large reduction in all pain groups except for the small sample of patients with mild pain.</p> <p> In this study, more patients in the BFA group presented to the ED with lower extremity pain, such as gout or neuropathy, compared with the ketorolac group; however, BFA did not result in a significantly different pain score reduction in this subgroup compared with ketorolac. Patients receiving BFA were more likely to receive topical analgesics or muscle relaxants at discharge; whereas those receiving ketorolac were significantly more likely to receive oral NSAIDs. Patients in this study also were more likely to be admitted to the hospital if they received ketorolac; however, for these patients, pain was secondary to their chief presentation, and the admitting physician’s familiarity with ketorolac might have been the reason for choosing this intervention. Reasons for the admissions were surgical observation, psychiatric stabilization, kidney/gallstones, rule out of acute coronary syndrome, pneumonia, and proctitis in the ketorolac group, and suicidal ideations in the BFA group.</p> <h3>Limitations</h3> <p>As a limited number of patients received BFA at JBVAMC, the study was not sufficiently powered to detect a difference in the primary outcome. Because BFA required a consultation to be entered in the electronic health record, in addition to time needed to perform the procedure, practitioners might have preferred IV/IM ketorolac during busy times in the ED, potentially leading to underrepresentation in the BFA group. Prescribing preferences might have differed among the rotating physicians, timing of the documentation of the NRS pain score could have differed based on the treatment intervention, and the investigators were unable to control or accurately assess whether patients had taken an analgesic medication before presenting to the ED. <hl name="33574"/>Because pain and the treating physician are subjective, patients who reported a higher baseline pain severity might have been more likely to be discharged with topical analgesics or muscle relaxants. One way to correct for this subjectivity would be to conduct a larger prospective trial with a single treating physician. Finally, ED encounters in this study were short, and there was no follow-up permitting identification of AEs.</p> <h2>Conclusions</h2> <p>NRS pain score reduction with BFA did not differ compared with ketorolac 15 mg for treating acute and acute-on-chronic pain in the ED. Although this study was underpowered, these results add to the limited existing literature, suggesting that both interventions could result in clinically significant pain score reductions for patients presenting to the ED with severe and very severe pain, making BFA a viable nonpharmacologic option. Future studies could include investigating the benefit of BFA in the veteran population by studying larger samples in the ED, surveying patients after their interventions to identify rates AEs, and exploring the use of BFA for chronic pain in the outpatient setting.</p> <h3> Author affiliations </h3> <p> <em><sup>a</sup>Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois<br/><br/><sup>b</sup>University of Illinois at Chicago College of Pharmacy</em> </p> <h3> Author disclosures </h3> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <h3> Disclaimer </h3> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.</em> </p> <h3> Ethics and consent </h3> <p> <em>This study was approved by the Jesse Brown Veterans Affairs Medical Center Institutional Review Board in Chicago, Illinois.</em> </p> <h3> References </h3> <p class="reference"> 1. Cantrill SV, Brown MD, Carlisle RJ, et al. Clinical policy: critical issues in the prescribing of opioids for adult patients in the emergency department. <i>Ann Emerg Med</i>. 2012;60(4):499-525. doi:10.1016/j.annemergmed.2012.06.013<br/><br/> 2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. <i>J Pain</i>. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021 <br/><br/> 3. Motov S, Strayer R, Hayes BD, et al. The treatment of acute pain in the emergency department: a white paper position statement prepared for the American Academy of Emergency Medicine. <i>J Emerg Med</i>. 2018;54(5):731-736. doi:10.1016/j.jemermed.2018.01.020<br/><br/> 4. Samcam I, Papa L. Acute pain management in the emergency department. In: Prostran M, ed. <i>Pain Management. </i>IntechOpen; 2016. doi:10.5772/62861<br/><br/> 5. Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the use of opioids in the management of chronic pain. Accessed February 15, 2023. https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOpioidsCPG.pdf<br/><br/> 6. Davis MT, Mulvaney-Day N, Larson MJ, Hoover R, Mauch D. Complementary and alternative medicine among veterans and military personnel: a synthesis of population surveys. <i>Med Care</i>. 2014;52(12 suppl 5):S83-590. doi:10.1097/MLR.0000000000000227<br/><br/> 7. Goertz C, Marriott BP, Finch FD, et al. Military report more complementary and alternative medicine use than civilians. <i>J Altern Complement Med</i>. 2013;19(6):509-517. doi:10.1089/acm.2012.0108<br/><br/> 8. King HC, Hickey AH, Connelly C. Auricular acupuncture: a brief introduction for military providers. <i>Mil Med</i>. 2013;178(8):867-874. doi:10.7205/MILMED-D-13-00075<br/><br/> 9. Niemtzow RC. Battlefield acupuncture. <i>Medical Acupunct</i>. 2007;19(4):225-228. doi:10.1089/acu.2007.0603<br/><br/>10. Collinsworth KM, Goss DL. Battlefield acupuncture and physical therapy versus physical therapy alone after shoulder surgery. <i>Med Acupunct</i>. 2019;31(4):228-238. doi:10.1089/acu.2019.1372<br/><br/>11. Estores I, Chen K, Jackson B, Lao L, Gorman PH. Auricular acupuncture for spinal cord injury related neuropathic pain: a pilot controlled clinical trial. <i>J Spinal Cord Med</i>. 2017;40(4):432-438. doi:10.1080/10790268.2016.1141489<br/><br/>12. Federman DG, Radhakrishnan K, Gabriel L, Poulin LM, Kravetz JD. Group battlefield acupuncture in primary care for veterans with pain. <i>South Med J</i>. 2018;111(10):619-624. doi:10.14423/SMJ.0000000000000877 <br/><br/>13. Garner BK, Hopkinson SG, Ketz AK, Landis CA, Trego LL. Auricular acupuncture for chronic pain and insomnia: a randomized clinical trial. <i>Med Acupunct</i>. 2018;30(5):262-272. doi:10.1089/acu.2018.1294 <br/><br/>14. Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency department. <i>Am J Emerg Med</i>. 2018; 36:1045-1048. doi:10.1016/j.ajem.2018.02.038<br/><br/>15. Woo A, Lechner B, Fu T, et al. Cut points for mild, moderate, and severe pain among cancer and non-cancer patients: a literature review. <i>Ann Palliat Med</i>. 2015;4(4):176-183. doi:10.3978/j.issn.2224-5820.2015.09.04 <br/><br/>16. Motov S, Yasavolian M, Likourezos A, et al. Comparison of intravenous ketorolac at three single-dose regimens for treating acute pain in the emergency department: a randomized controlled trial. <i>Ann Emerg Med</i>. 2017;70(2):177-184. doi:10.1016/j.annemergmed.2016.10.014<br/><br/>17. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. <i>Acad Emerg Med</i>. 2003;10:390-392. <span class="citation-doi">doi:10.1111/j.1553-2712.2003.tb01355.</span></p> </itemContent> </newsItem> </itemSet></root>
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