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

Neuropathy, a common complication affecting nearly half of patients with diabetes, has a high patient burden resulting from painful symptoms, activity limitation, polypharmacy, and overall reduced health-related quality of life. Anti-convulsants and tricyclic anti-depressants provide at least moderate pain relief for 25-50% of patients, but often with adverse side effects, such as dry mouth, dizziness, nausea, and urinary problems. The burden of diabetic neuropathy is exacerbated for older adults due to a higher prevalence associated with age, greater impact on activities of daily living, and increased risk of falls and fractures associated with analgesic medications. Effective, non-pharmaceutical approaches for painful diabetic neuropathy (PDN) are needed, particularly for older, racial/ethnic minorities at highest risk of diabetes and related complications.

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Acupuncturist Ninah Hofmann
administers a treatment.

Acupuncture provides effective pain relief and functional improvement for a range of chronic pain conditions, and is a promising treatment for PDN. Prior studies suggest that acupuncture increases blood flow, improves nerve conduction velocity, and decreases pain among patients with PDN, but are limited by lack of randomization, inconsistent treatment protocols, and small sample sizes. The primary objective of this study is to evaluate the feasibility of key study design features for a clinical trial of group acupuncture for painful diabetic neuropathy (PDN) among underserved patients, such as the success of recruitment, randomization, and retention of participants and the usability of a manualized intervention of group acupuncture for PDN.

Secondary objectives of the study are to evaluate 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 optimal frequency of acupuncture (once weekly vs. twice weekly group acupuncture treatments). We are conducting a randomized, non-blinded design with three arms:

  1. usual care combined with 12 weeks of group acupuncture twice weekly,
  2. usual care combined with 12 weeks of group acupuncture once weekly, or
  3. usual care alone.

Participants randomized to one of the acupuncture arms will receive treatments delivered in a group setting, which consists of a common space with multiple reclining chairs. Acupuncture procedures will be administered using a treatment manual designed to balance individualized treatment approaches with standardized protocols necessary for rigorous study design.

Our target population is patients of the San Francisco General Hospital outpatient clinics who have PDN. For this pilot, we will recruit and enroll 60 patients with PDN who have been seen at SFGH in an outpatient clinic at least once within the prior year. Study participants will be randomized in equal numbers to the three arms (n=20 in each arm). Testing complementary and integrative health interventions to improve health-related quality of life among low-income and racial/ethnic minority patients is an innovative, non-pharmacologic approach to pressing public health needs of underserved patients with chronic conditions. In addition, the study design reflects ‘real-world’ practices by using a group model common in community acupuncture clinics that has not yet been rigorously evaluated.

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Acupuncturist Ninah Hofmann administers a treatment as Primary Investigator
Dr. Maria Chao (R) and Research Associate Trilce Santana discuss the project.

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