Original Research

A Treatment Protocol for Patients With Diabetic Peripheral Neuropathy

Fed Pract. 2015 September;32(9):68-73

References

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The POQ-VA, a subjective quality of life (QOL) measure for veterans, as well as VAS, SWM testing, and the Tinetti Gait and Balance Assessment scores were used to measure outcomes. Data were collected for each of these measures during the initial and 12th clinic visits and at the 3-month and 6-month follow-up visits. The POQ-VA and VAS scores were self-reported and filled out by each participant at the initial, 12th, 3-month, and 6-month visits. The POQ-VA score has proven to be reliable and valid for the assessment of noncancer, chronic pain in veterans. ¹⁹ The VAS scores were measured using a scale of 0 to 10 cm.

The SWM was standardized, and 7 sites were tested on each foot during the initial, 12th, 3-month, and 6-month visits: plantar surface of the distal great toe, the distal 3rd toe, the distal 5th toe, the 1st metatarsal head, the 3rd metatarsal head, the 5th metatarsal head, and the mid-plantar arch. At each site, the SWM was applied with just enough force to initiate a bending force and held for 1.5 seconds. Each site was tested 3 times. Participants had to detect the monofilament at least twice for the monofilament value to be recorded. Monofilament testing began with 6.65 SWM and decreased to 5.07, 4.56, 4.32, and lower until the patient was no longer able to detect sensation.

The Tinetti Gait and Balance Assessments was performed on each participant at the initial, 12th, 3-month, and 6-month visits. Tinetti balance, gait, and total scores were recorded at each interval.

Results

Thirty-three patients, referred by primary care providers and specialty clinics, met the inclusion criteria and enrolled in the study. Twenty-one patients (20 men and 1 woman) completed the entire 6-month study. Causes for withdrawal included travel difficulties (5), did not show up for follow-up visits (4), lumbar radiculopathy (1), perceived minimal/no benefit (1), and unrelated death (1). No AEs were reported.

The Friedman test with DMC post hoc test was performed on the POQ-VA total score and subscale scores. The POQ-VA subscale scores were divided into the following domains: pain, activities of daily living (ADL), fear, negative affect, mobility, and vitality. The POQ-VA domains were analyzed to compare data from the initial, 12th, 3-month, and 6-month visits. The POQ-VA total score significantly decreased from the initial to the 12th visit ( P < .01), from the initial to the 3-month ( P < .01), and from the initial to the 6-month visit ( P < .05). However, there was no significant change from the 12th visit to the 3-month follow-up, 12th visit to the 6-month follow-up, or the 3-month to 6-month follow-up.

The POQ-VA pain score decreased significantly from the initial to the 12th visit ( P < .05) and from the initial to the 6-month visit ( P < .05). However, there was no significant interval change from the initial to the 3-month, the 12th to 3-month, 12th to 6-month, or 3-month to 6-month visit (Figure 1). The POQ-VA vitality scores and POQ-VA fear scores did not yield significant changes. The POQ-VA negative affect scores showed significant improvement only between the initial and the 3-month visit ( P < .05) (Figure 2). The POQ-VA ADL scores showed significant improvement in the initial vs 3-month score ( P < .05). The POQ-VA mobility scores were significantly improved for the initial vs 12th visit ( P < .01), initial vs 3-month visit ( P < .01), and the initial vs 6-month visit ( P < .001) (Figure 1).