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NCT05004194 · ClinicalTrials.gov registry record · NA
Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT05004194: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05004194 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05004194, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. The food and drug administration (FDA) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. Accordingly, there exists a need for novel therapeutics. The researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (VCS). VCS, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. VCS is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. There currently exists limited data on the topic, only case reports and case series. Given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.
Primary Outcome
Change in average diary pain scores assessed by daily report on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale range from 0-10, higher score indicates more pain.
Interventions
- PROCEDURE Vestibular Caloric Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-03-19 |
| Est. Completion | 2021-07-02 |
| Phase | NA |
What the finished NCT05004194 record still lists
NCT05004194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Vestibular Caloric Stimulation is the first listed.
NCT05004194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05004194 about?
NCT05004194 is a clinical study titled "Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia". The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consul...
What is the current status of trial NCT05004194?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2021-03-19. Estimated completion is 2021-07-02.
What interventions are being tested in trial NCT05004194?
The interventions under investigation include: Vestibular Caloric Stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT05004194?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05004194's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 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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