Vestibulocortical Stimulation for Fibromyalgia
(VIPR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Michael Kaplan, MD
Principal Investigator
Mount Sinai Hospital, Icahn School of Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single session of vestibulocortical stimulation (VCS) or sham stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vestibular Innovation in Pain 2
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
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