Vestibular Innovation in Pain 2
VIPR
Vestibular Innovation in Pain: A Randomized Controlled Trial
1 other identifier
interventional
56
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2026
CompletedFirst Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
February 20, 2026
February 1, 2026
1.5 years
February 13, 2026
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain numeric rating scale (NRS)
Change in NRS as compared to baseline. Pain numeric rating scale (NRS), Full score on scale from 0-10 (0 = no pain; 10 = pain as bad as you can imagine). Higher scores indicate more pain.
Baseline and 1 week
Secondary Outcomes (6)
Change in Pain numeric rating scale (NRS)
30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks
Overall Well Being Scale
30 minutes
Patient Global Impression of Change (PGIC)
24 hr, 1 week, 2 weeks, 3 weeks, 4 weeks
Brief Pain Inventory (Short-Form; BPI-SF)
24 hrs, 1 week, 2 weeks, 3 weeks, 4 weeks
Patient Reported Outcomes Measurement Information System (PROMIS-29)
1 week, 2 weeks, 3 weeks, 4 weeks
- +1 more secondary outcomes
Study Arms (2)
Vestibulocortical Stimulation
EXPERIMENTALParticipants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Sham Stimulation
SHAM COMPARATORParticipants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 severe hypertension
- History of vestibular schwannoma or meningioma resection.
- Patients taking opioid therapy (not including tramadol).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai West
New York, New York, 10019, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Kaplan, MD
Mount Sinai Hospital, Icahn School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- A blind-to-hypothesis approach will be used. Investigators and participants will not be blinded to temperature of water as the procedure itself does not lend to it.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 20, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Deidentified individual participant data will not be made available because participants did not provide consent for data sharing beyond the scope of the present study. Aggregate data supporting the findings are included in the article.