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

Completed · Not applicable

Conditions studied: Diabetic Peripheral Neuropathy

In brief

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: 1. decreased pain intensity 2. improved health-related quality of life 3. improved sural nerve conduction velocity

Key facts

Study ID: NCT02104466
Run by: University of California, San Francisco
People needed: 40
Starts: 2015-03-01
Expected to finish: 2016-03-01
Last updated by the study team: 2017-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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