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NCT02104466 · ClinicalTrials.gov registry record · NA
Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)
A NA study of Diabetic Peripheral Neuropathy, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02104466: Completed NA study of Diabetic Peripheral Neuropathy, sponsored by University of California, San Francisco.
NCT02104466 is a NA study of Diabetic Peripheral Neuropathy that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 126-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02104466, a NA study of Diabetic Peripheral Neuropathy, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- PROCEDURE Acupuncture
Study Locations (1)
California
- San Francisco General Hospital - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-03 |
| Phase | NA |
What the finished NCT02104466 record still lists
NCT02104466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 126-participant average among 17 other Diabetic Peripheral Neuropathy trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Diabetic Peripheral Neuropathy appearing as the primary indexed condition, and to 1 intervention - of which Acupuncture is the first listed.
NCT02104466 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02104466 about?
NCT02104466 is a clinical study titled "Group Acupuncture Treatment Effects for Painful Diabetic Neuropathy (GATE-PDN)". 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-convulsa...
What is the current status of trial NCT02104466?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2015-03. Estimated completion is 2016-03.
What conditions does trial NCT02104466 study?
This clinical trial studies the following conditions: Diabetic Peripheral Neuropathy.
What interventions are being tested in trial NCT02104466?
The interventions under investigation include: Acupuncture (PROCEDURE).
Who is sponsoring clinical trial NCT02104466?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02104466 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02104466's enrollment target sits among peer trials
40 15th of 17 higher than 3 of 17 other Diabetic Peripheral Neuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Peripheral Neuropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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