Clinical trial NCT02104466: Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)
Official title: Randomized Controlled Pilot Trial of Adjunct Group Acupuncture vs Usual Care Among Patients With Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: acupuncture
pain
neuropathy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of recruited participants retained for the 12-week intervention period
timeFrame: 12 weeks
measure: Change from baseline in average weekly pain on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at week 12
timeFrame: Baseline, Weeks 1-12
Secondary outcomes:
measure: Pain Qualities Assessment Scale
timeFrame: Baseline, Weeks 1-12, Week 24
measure: Health-related quality of life
timeFrame: Baseline, Week 6, Week 12, Week 18
measure: Depressive symptoms using the Patient Health Questionnaire
timeFrame: Baseline, Week 6, Week 12, Week 18
measure: Participant rating of global improvement using the Patient Global Impression of Change scale
timeFrame: Week 12
measure: Patient-centered symptom severity using the Measure Yourself Medical Outcome Profile
timeFrame: Baseline, Week 6, Week 12, Week 18
measure: NIH PROMIS Sleep Disturbance Scale
timeFrame: Baseline, Week 6, Week 12, Week 18
measure: Protective sensation of the feet using a 5.07 Semmes-Weinstein monofilament
timeFrame: Baseline, Week 12, Week 18
measure: Patient satisfaction
timeFrame: Week 12
Other outcomes:
measure: Use of medications at baseline and throughout 12-week intervention period
timeFrame: Baseline, Week 12
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maria T Chao, DrPH, MPA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chao MT, Schillinger D, Nguyen U, Santana T, Liu R, Gregorich S, Hecht FM. A Randomized Clinical Trial of Group Acupuncture for Painful Diabetic Neuropathy Among Diverse Safety Net Patients. Pain Med. 2019 Nov 1;20(11):2292-2302. doi: 10.1093/pm/pnz117.