RecruitingNot ApplicableNCT07423377

Vestibular Innovation in Pain 2

Vestibular Innovation in Pain: A Randomized Controlled Trial


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

56 participants

Start Date

Mar 19, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe \& cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain \& improving quality of life using validated patient-reported outcomes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Vestibulocortical Stimulation for people with fibromyalgia and nociplastic pain. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVestibulocortical Stimulation

VCS is a non-invasive bedside procedure using temperate water, and a plastic syringe (no needles). With the participant laying supine, temperate water is irrigated into the external ear canal at 1-2 cc/second.


Locations(1)

Mount Sinai West

New York, New York, United States

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NCT07423377


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