Warm water in the ear canal for fibromyalgia pain
Tests rinsing the ear canal with temperate water for fibromyalgia pain in adults.
Key facts
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Where
- New York, United StatesSee the site
- Trial code
- Registry title
- Vestibular Innovation in Pain 2
- Status
- Recruiting
- People taking part
- 56 people, planned
- Started
- 19 Mar 2026
- Expected to end
- 31 Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Vestibulocortical Stimulation
- Record updated
- 8 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with fibromyalgia and ongoing pain. It tests one session of rinsing the right ear canal with warm or cold water, compared with a sham (fake) session.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Fibromyalgia diagnosed with the American College of Rheumatology 2016 questionnaire. Pain score of 4/10 or more and less than 10/10 when joining.
- Earlier treatment
- People taking opioid pain medicines cannot join. Tramadol is allowed.
Main reasons for not taking part
- Past eardrum injury, rupture or surgery, including ear tubes or a cochlear implant
- Right ear infection in the last 3 months, or right ear pain now
- Current pregnancy, bipolar disorder, or a history of seizures
- Heart attack, stroke, TIA or heart bypass surgery in the last 3 months
- Getting disability benefits for fibromyalgia, or in a legal case about it
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia
- Patients taking opioid therapy (not including tramadol)
- 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
- 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)
- 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 severe hypertension
- History of vestibular schwannoma or meningioma resection
- Current pregnancy
- Inability to lay supine for 15 minutes
Where in United States
- Mount Sinai WestNew York, United StatesContact: Michael Kaplan (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Vestibulocortical StimulationTreatment being tested
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
- Sham StimulationSham treatment, for comparison
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Treatment: Vestibulocortical Stimulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Vestibular Innovation in Pain: A Randomized Controlled Trial
- Plain-language title
- Warm water in the ear canal for fibromyalgia painGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 8 June 2026