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NCT04115033 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of CES for Fibromyalgia
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT04115033: Completed NA study, sponsored by VA Office of Research and Development.
NCT04115033 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115033, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 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. CES (Cranial Electrical 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.
Interventions
- DEVICE Alpha-stim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-03-02 |
| Est. Completion | 2024-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04115033
The ClinicalTrials.gov registry entry for NCT04115033 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alpha-stim is the first listed.
NCT04115033 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04115033 about?
NCT04115033 is a clinical study titled "Randomized Controlled Trial of CES 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 NCT04115033?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2020-03-02. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT04115033?
The interventions under investigation include: Alpha-stim (DEVICE).
Who is sponsoring clinical trial NCT04115033?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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