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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02104466
First received: March 27, 2014
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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. Forty-eight 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 (16 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

Condition Intervention
Diabetic Peripheral Neuropathy
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Pilot Trial of Adjunct Group Acupuncture vs Usual Care Among Patients With Painful Diabetic Neuropathy

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Percentage of recruited participants retained for the 12-week intervention period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Qualities Assessment Scale [ Time Frame: Baseline, Weeks 1-12, Week 24 ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
    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

  • Depressive symptoms using the Patient Health Questionnaire [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Participant rating of global improvement using the Patient Global Impression of Change scale [ Time Frame: Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Patient-centered symptom severity using the Measure Yourself Medical Outcome Profile [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • NIH PROMIS Sleep Disturbance Scale [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Protective sensation of the feet using a 5.07 Semmes-Weinstein monofilament [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Sural nerve conduction velocity using the NC-Stat / DPNCheck [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
    The NC-Stat / DPNCheck is a non-invasive handheld device used to measure sural nerve conduction velocity.

  • Patient satisfaction [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    At Week 24, an exit interview will be administered to inquire about satisfaction with the acupuncture services and study procedures.


Other Outcome Measures:
  • Use of medications at baseline and throughout 12-week intervention period [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: May 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as Usual (TAU)
Experimental: TAU + 12 wks of acupuncture 1x/week 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English or Spanish 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104466

Contacts
Contact: Maria T Chao, DrPH, MPA 415.353.7749 chaom@ocim.ucsf.edu

Locations
United States, California
San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Principal Investigator: Maria T Chao, DrPH, MPA         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Maria T Chao, DrPH, MPA University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02104466     History of Changes
Other Study ID Numbers: 14-12822, K01AT006545
Study First Received: March 27, 2014
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
acupuncture
pain
neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014