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

Study Overview
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Brief Summary
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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: decreased pain intensity improved health-related quality of life improved sural nerve conduction velocity

Official Title
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Randomized Controlled Pilot Trial of Adjunct Group Acupuncture vs Usual Care Among Patients With Painful Diabetic Neuropathy

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, pain, neuropathy