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

Not Applicable

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Procedure: Acupuncture

• Registration Number: NCT02104466
• Lead Sponsor: University of California, San Francisco

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Study Start: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU + 12 wks of acupuncture 2x/week	Acupuncture	Participants randomized to this arm will receive usual care with adjunctive acupuncture twice per week for a period of 12 weeks.
TAU + 12 wks of acupuncture 1x/week	Acupuncture	Participants randomized to this arm will receive usual care with adjunctive acupuncture once per week for a period of 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of recruited participants retained for the 12-week intervention period	12 weeks
Change from baseline in average weekly pain on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at week 12	Baseline, Weeks 1-12

Secondary Outcome Measures

Name	Time	Method
Participant rating of global improvement using the Patient Global Impression of Change scale	Week 12
Protective sensation of the feet using a 5.07 Semmes-Weinstein monofilament	Baseline, Week 12, Week 18
Pain Qualities Assessment Scale	Baseline, Weeks 1-12, Week 24
Health-related quality of life	Baseline, Week 6, Week 12, Week 18	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
Patient satisfaction	Week 12	At Week 12, an exit interview will be administered to inquire about satisfaction with the acupuncture services and study procedures.
Depressive symptoms using the Patient Health Questionnaire	Baseline, Week 6, Week 12, Week 18
Patient-centered symptom severity using the Measure Yourself Medical Outcome Profile	Baseline, Week 6, Week 12, Week 18
NIH PROMIS Sleep Disturbance Scale	Baseline, Week 6, Week 12, Week 18

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States