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Vestibular Innovation in Pain 2

NCT07423377 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Fibromyalgia
  • Nociplastic Pain

Interventions

PROCEDURE

Vestibulocortical 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.

Sponsors & Collaborators

Principal Investigators

  • Michael Kaplan, MD · Mount Sinai Hospital, Icahn School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07423377 on ClinicalTrials.gov