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Trial record 30 of 65 for:    dry mouth | NIH

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

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ClinicalTrials.gov Identifier: NCT02104466
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

March 27, 2014
April 4, 2014
May 31, 2017
March 2015
December 2015   (Final data collection date for primary outcome measure)
  • Percentage of recruited participants retained for the 12-week intervention period [ Time Frame: 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 ]
Same as current
Complete list of historical versions of study NCT02104466 on ClinicalTrials.gov Archive Site
  • Pain Qualities Assessment Scale [ Time Frame: 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
  • Depressive symptoms using the Patient Health Questionnaire [ Time Frame: Baseline, Week 6, Week 12, Week 18 ]
  • Participant rating of global improvement using the Patient Global Impression of Change scale [ Time Frame: Week 12 ]
  • Patient-centered symptom severity using the Measure Yourself Medical Outcome Profile [ Time Frame: Baseline, Week 6, Week 12, Week 18 ]
  • NIH PROMIS Sleep Disturbance Scale [ Time Frame: 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 ]
  • 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.
  • Pain Qualities Assessment Scale [ Time Frame: Baseline, Weeks 1-12, Week 24 ]
  • Health-related quality of life [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ]
    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 ]
  • Participant rating of global improvement using the Patient Global Impression of Change scale [ Time Frame: Week 4, Week 8, Week 12, Week 24 ]
  • Patient-centered symptom severity using the Measure Yourself Medical Outcome Profile [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ]
  • NIH PROMIS Sleep Disturbance Scale [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ]
  • Protective sensation of the feet using a 5.07 Semmes-Weinstein monofilament [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ]
  • Sural nerve conduction velocity using the NC-Stat | DPNCheck [ Time Frame: Baseline, Week 12, Week 24 ]
    The NC-Stat | DPNCheck is a non-invasive handheld device used to measure sural nerve conduction velocity.
  • Patient satisfaction [ Time Frame: Week 24 ]
    At Week 24, an exit interview will be administered to inquire about satisfaction with the acupuncture services and study procedures.
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.
Same as current
 
Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)
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
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Peripheral Neuropathy
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.
  • 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.
    Intervention: Procedure: Acupuncture
  • 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.
    Intervention: Procedure: Acupuncture

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
48
March 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02104466
14-12822
K01AT006545 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Maria T Chao, DrPH, MPA University of California, San Francisco
University of California, San Francisco
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP