Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN) (GATE-PDN)

Randomized Controlled Pilot Trial of Adjunct Group Acupuncture vs Usual Care Among Patients With Painful Diabetic Neuropathy

Peripheral neuropathy is a common complication of diabetes, and one of the strongest determinants of reduced health-related quality of life among people with diabetes. Neuropathy frequently presents with painful symptoms, activity limitation, insomnia, fatigue, and depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at least moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN), but often decrease other domains of quality of life through adverse effects, such as dry mouth, dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical approaches for PDN are needed, particularly for low income and racial/ethnic minorities who are at highest risk of diabetes and related complications. Acupuncture is a promising treatment for PDN, but evidence is limited. To address the significant public health need related to pain management among underserved people with diabetes, this study proposes an innovative, group-based model of acupuncture for PDN at an urban safety net hospital. Sixty patients who have PDN will be enrolled and randomized to one of three arms: (a) usual care combined with 12 weeks of group acupuncture twice weekly, (b) usual care combined with 12 weeks of group acupuncture once weekly, or (c) usual care alone (20 in each group). The aims of the study are to determine the feasibility of group acupuncture for PDN among underserved patients with diabetes; to evaluate the preliminary treatment effects of group acupuncture on pain, health-related quality of life, depressive symptoms, sleep disturbance, nerve conduction velocity, and protective sensation; and to determine the optimal frequency of acupuncture treatments. The investigators hypothesize that compared to patients receiving usual care alone, patients who undergo weekly group acupuncture treatments will have: decreased pain intensity improved health-related quality of life improved sural nerve conduction velocity

Participants randomized to this arm will receive usual care with adjunctive acupuncture once per week for a period of 12 weeks.

Participants randomized to this arm will receive usual care with adjunctive acupuncture twice per week for a period of 12 weeks.

Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. The initial acupuncture treatment will include a one-on-one diagnostic interview with one of the study acupuncturists for up to 30 minutes, followed by administration of acupuncture needles retained for 20-40 minutes. For subsequent group acupuncture treatments, participants will have a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Eight to twelve needles will be administered in acupuncture points selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.

Change from baseline in average weekly pain on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at week 12

The following questionnaires will be used: Norfolk Quality of Life Questionnaire - Diabetic Neuropathy; Diabetes Distress Scale; Brief Pain Inventory Interference Scale; Centers for Disease Control and Prevention Healthy Days Measure

At Week 12, an exit interview will be administered to inquire about satisfaction with the acupuncture services and study procedures.

Data about medication use will be extracted from the participant's medical chart, including type(s) of analgesics, total dose, and the number of agents.

Inclusion Criteria: English, Spanish, or Cantonese speaking Diagnosed with type 2 diabetes mellitus Distal lower limb pain present for at least three months A score of 4 or greater on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) for the pain of diabetic peripheral neuropathy at least four days a week before randomization Pain characterized as burning, shooting, or stabbing in nature Ability to understand study procedures and willingness to comply with them for the entire length of the study A score of less than 8 on the Semmes-Weinstein monofilament test Stable use of pain control medications for PDN in the one month prior to screening (e.g. no change in prescription) or no use of pain control medications for PDN within the past one month Exclusion Criteria: Substance abuse (as assessed by the Simple Screening Instrument for Substance Abuse) Unstable medical condition (e.g. severe pulmonary disease, myocardial infarction, severe depressive symptoms) Electrical therapy (e.g. TENS unit) or patch treatment (e.g. lidocaine or capsaicin) for PDN used within the past two weeks Acupuncture, moxibustion, cupping or herbal medicine for PDN used within the past two weeks Pregnancy, planning a pregnancy or breast-feeding Inability or unwillingness to comply with this study protocol, assessed prior to randomization

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