Vestibular Innovation in Pain 2

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07423377
Status
Recruiting
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Conditions

  • Fibromyalgia
  • Nociplastic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vestibulocortical Stimulation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Mar 19, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vestibulocortical Stimulation
    Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
  • Sham Comparator: Sham Stimulation
    Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.

Primary Outcome Measure

Change in Pain numeric rating scale (NRS) [ Time Frame: Baseline and 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai WestNew YorkNew York10019
Michael Kaplan (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai West· New York, NY

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