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NCT03008837 · ClinicalTrials.gov registry record · NA
Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT03008837: Completed NA study, sponsored by VA Office of Research and Development.
NCT03008837 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03008837, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Given recent increasing opioid-related deaths and evidence showing against the use of opioids for non-malignant chronic pain, there is growing need for non-narcotic pain management. Fibromyalgia is a difficult to treat chronic pain condition that is often treated with opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans returning from the gulf war and is already a significant burden in senior Veterans who may have suffered with chronic pain for decades already. Many treatment options for fibromyalgia carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA system, but sufficient evidence regarding its outcomes and neural mechanisms have not been adequately investigated. An understanding of its neural underpinnings and analgesic effects could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3) development of new techniques to address pain.
Primary Outcome
2 weeks following the final treatment, subjects in the PENFS group were be evaluated for changes in functional connectivity between the right posterior insula seed and other areas of the DMN as evaluated by fcMRI relative to standard treatment controls, using whole brain analysis. The measurement is increase/decrease of signal in a given region, thresholded at p \<0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects scans were com
Interventions
- DEVICE Military Field Stimulator
- OTHER Standard Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2019-05-31 |
| Phase | NA |
What the finished NCT03008837 record still lists
NCT03008837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Military Field Stimulator is the first listed.
NCT03008837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03008837 about?
NCT03008837 is a clinical study titled "Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia". Given recent increasing opioid-related deaths and evidence showing against the use of opioids for non-malignant chronic pain, there is growing need for non-narcotic pain management. Fibromyalgia is a difficult to treat chronic pain condition that is often treated with opioids despite existing eviden...
What is the current status of trial NCT03008837?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2017-06-01. Estimated completion is 2019-05-31.
What interventions are being tested in trial NCT03008837?
The interventions under investigation include: Military Field Stimulator (DEVICE), Standard Therapy (OTHER).
Who is sponsoring clinical trial NCT03008837?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03008837's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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