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

Summary

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

Conditions

• Diabetic Peripheral Neuropathy

Interventions

PROCEDURE

Acupuncture

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Maria T Chao, DrPH, MPA · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2015-12-31

Completion

2016-03-31

Countries

• United States

Study Locations