PROGRAM PROFILE

Nonopioid Alternatives to Addressing Pain Intensity: A Retrospective Look at 2 Noninvasive Pain Treatment Devices

Fed Pract. 2019 April;36(4):181-187

References

1. US Department of Veterans Affairs. Pain as the 5th Vital Sign Toolkit. https://www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Published October 2000. Accessed February 11, 2019.

2. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.

3. Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: Controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008;16(5):405-416.

4. Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013;109(1):5-12.

5. Mosher HJ, Krebs EE, Carrel M, Kaboli PJ, Weg MW, Lund BC. Trends in prevalent and incident opioid receipt: an observational study in Veterans Health Administration 2004-2012. J Gen Intern Med. 2015;30(5):597-604.

6. Reuben DB, Alvanzo AAH, Ashikaga T, et al. National Institutes of Health Pathways to Prevention Workshop: The role of opioids in the treatment of chronic pain. Ann Intern Med. 2015;162(4):295-300.

7. Murthy VH. Opioid epidemic: we all have a role in turning the tide. https://obamawhitehouse.archives.gov/blog/2016/10/05/opioid-epidemic-we-all-have-role-turning-tide. Published October 5, 2016. Accessed February 12, 2019.

8. Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056.

9. Crane P, Feinberg L, Morris J. A multimodal physical therapy approach to the management of a patient with temporomandibular dysfunction and head and neck lymphedema: a case report. J Man Manip Ther. 2015;23(1): 37-42.

10. Arnstein P. Multimodal approaches to pain management. Nurs. 2011;41(3): 60-61.

11. Alpha-Stim. http://www.alpha-stim.com. Accessed March 22, 2019

12. Shekelle PG, Cook IA, Miake-Lye IM, Booth MS, Beroes JM, Mak S. Benefits and harms of cranial electrical stimulation for chronic painful conditions, depression, anxiety, and insomnia. Ann Intern Med. 2018;168(6):414-421.

13. Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study. Pain. 2006;124(1):201-210.

14. Kulkarni AD, Smith RB. The use of microcurrent electrical therapy and cranial electrotherapy stimulation in pain control. Clin Pract Alternative Med. 2001;2(2):99-102.

15. Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009;374(9705):1897-1908.

16. Taylor AG, Anderson JG, Riedel SL, et al. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Manag Nurs. 2013;14(4):327-335.

17. Beck, AT, Steer, RA, Brown, GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.

18. Beck AT, Steer RA. Beck Anxiety Inventory: Manual. San Antonio, TX: Psychological Corporation; 1993.

19. Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524-532.

20. Wolpe J. The Practice of Behavior Therapy. 4th ed. Elmsford, NY: Pergamon; 1990.

21. Cleeland CS. The Brief Pain Inventory User Manual. https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html. Published 2009. Accessed February 12, 2019.

22. Gerrits MM, van Marwijk HW, van Oppen P, Horst HVD, Penninx BW. Longitudinal association between pain, and depression and anxiety over four years. J Psychosom Res. 2015;78(1):64-70.

23. The Joint Commission. Joint Commission enhances pain assessment and management requirements for accredited hospitals. The Joint Commission Perspectives. https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF. Published July 2017. Accessed March 21, 2019.

Training and Device Trials

Eligible veterans are educated about the device and complete clinical informed consent, which is documented in the electronic health record. The veterans’ primary care and/or specialist providers are contacted for concurrence regarding veterans’ participation in the treatment.

Protocols for the device trials are based on the manufacturers’ recommendations, adjusted to what is feasible in the clinic (manufacturers approved the changes). The number of treatments per trial varies by device. For AS-M, veterans come to the clinic 5 days a week for 2 weeks. For LTO, veterans attend the clinic 5 days a week for 1 week.

At the beginning of a device trial, a trained facilitator teaches each veteran and caregiver to use the device, sets functional goals for the trial, and provides education on the trial questionnaires and daily pain logs. The veteran then follows the device protocol in the clinic where the facilitator can respond to questions and address any issues. With support from their caregivers, veterans are expected to become independent on their device use by the end of the trial. Clinic staff or the veteran can stop the device trial at any point, without affecting the veteran’s participation in or eligibility for other EOVAHCS pain programs.

This project was submitted to the University of Oklahoma Health Sciences Center Institutional Review Board and was exempted from institutional review board oversight as a retrospective, quality improvement effort. Before data analysis, the EOVAHCS Coordinator for Research and Development reviewed the procedures to ensure that all policies were being followed.

Methods

Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion.

Measures

Veterans completed the following measures at baseline and after trial completion:

The Beck Depression Inventory (BDI-II) is a 21-item measure designed to assess depressive symptoms. Each item assesses intensity on a 0-to-3 scale. Scores from 0 to 13 indicate minimum depression; 14 to 19, mild depression; 20 to 28, moderate depression, and 29 to 63, severe depression.¹⁷

The Beck Anxiety Inventory (BAI) is a 21-item measure of anxiety symptoms that uses a 0-to-3 scale to assess severity of subjective, somatic, or panic-related symptoms of anxiety. Scores ranging from 0 to 9 indicate minimal anxiety; 10 to 16, mild anxiety; 17 to 29, moderate anxiety, and 30 to 63, severe anxiety.¹⁸

The Pain Catastrophizing Scale (PCS) is a 13-item measure of pain catastrophizing, a crucial marker of how individuals experience pain. Items are scored on a 0-to-4 scale; scores of ≥ 30 indicate a clinically relevant level of catastrophizing.¹⁹

The Subjective Units of Distress Scale (SUD) is a single-item measure of the subjective intensity of disturbance or distress currently being experienced. It is scored from 0 to 10; 1 to 4 is mild, 5 to 6 is moderate, and 7 to 10 is severe.²⁰

The Brief Pain Inventory (BPI) measures pain intensity and the impact of pain on functioning. Four items assess pain intensity at its worst, least, and average over the previous 24 hours and at the time of assessment; responses are on a 0-to-10 scale with 10 being most severe. The pain intensity measure is the average of scores on these 4 items. Pain interference is measured with respect to 7 daily activities; general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of these items is scored on a 0-to-10 scale with 10 being the most severe. The pain interference measure is the average of scores on these 7 items.²¹

Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met.