RecruitingNot Applicable

Vestibular Innovation in Pain 2

United States56 participantsStarted 2026-03-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provision of signed and dated informed consent form * Age equal to or \>18 years old * Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure. * Owns or has access to a smart phone or computer to complete outcome measures * Fluency in English * Diagnosis of Fibromyalgia (FM) * Diagnosis by American College of Rheumatology 2016 questionnaire * Pain score 4/10 or more and less than 10/10 on the numeric rating scale at the time of inclusion. Exclusion Criteria: * History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or "ear tubes," and/or cochlear implant. * Right ear infection within the last 3 months, or current right ear pain. * Current pregnancy * Bipolar Disorder * History of seizures (including non-epileptiform seizures) * History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke) * Inability to lay supine for 15 minutes * Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia. * Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study. * History of or current Meniere's Disease * History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months * History of hospitalization for s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pain numeric rating scale (NRS)

Timeframe: Baseline and 1 week

Trial details

NCT IDNCT07423377

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Talia Torkian

212-241-1671 viptrial@mountsinai.org

View on ClinicalTrials.gov More Fibromyalgia trials