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

May 30, 2017 updated by: University of California, San Francisco

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:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual (TAU)
Participants randomized to this arm will receive usual care with no acupuncture.
Experimental: TAU + 12 wks of acupuncture 1x/week
Participants randomized to this arm will receive usual care with adjunctive acupuncture once per week for a period of 12 weeks.
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.
Experimental: TAU + 12 wks of acupuncture 2x/week
Participants randomized to this arm will receive usual care with adjunctive acupuncture twice per week for a period of 12 weeks.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of medications at baseline and throughout 12-week intervention period
Time Frame: Baseline, Week 12
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.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Maria T Chao, DrPH, MPA, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-12822
  • K01AT006545 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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