FibromyalgiaVIPRNCT07423377
Vestibular Innovation in Pain 2
A study testing Vestibulocortical Stimulation in people with Fibromyalgia and Nociplastic Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Nociplastic Pain
- What is being tested?
- Vestibulocortical Stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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)
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai West
New York, New York, 10019
Michael Kaplan
About this study
Official title: Vestibular Innovation in Pain: A Randomized Controlled 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.
- Conditions
- Fibromyalgia, Nociplastic Pain
- Being tested
- Vestibulocortical Stimulation
- Keywords
- pain, quality of life
- Medical subject headings
- Fibromyalgia, Nociplastic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibulocortical StimulationProcedure or surgery
Also called VCS
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.
| Study group | Role | What they receive |
|---|---|---|
| Vestibulocortical Stimulation | Experimental | Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second. Receives: Procedure: Vestibulocortical Stimulation |
| Sham Stimulation | Sham comparator | Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second. Receives: Procedure: Vestibulocortical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week
Secondary outcomes (6)
Change in Pain numeric rating scale (NRS)
Change in Pain numeric rating scale (NRS) (acute and long term). 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.
Measured: 30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks
Overall Well Being Scale
Numeric rating scale scored from 0-10, 0 = lowest quality of life, 10 = best imaginable. Higher score indicates better health outcomes.
Measured: 30 minutes
Patient Global Impression of Change (PGIC)
Full scale scored from 0-7 scale. 0 = No change or condition has worsened; 7 = A great deal better with considerable improvement. Higher score indicates better health outcomes.
Measured: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks
Brief Pain Inventory (Short-Form; BPI-SF)
Validated patient reported outcome that measures both pain intensity and pain interference. The BPI-SF uses numeric rating scales (0-10) to evaluate worst, least, average, and current pain intensity, as well as pain interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life.
Pain intensity, Subscale scored from 0-10 NRS: 0 = no pain, 10 = worst pain imaginable.
Pain interference, Subscale scored from 0-10 NRS: 0= Does not interfere, 10 = Completely interferes.
Measured: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks
Patient Reported Outcomes Measurement Information System (PROMIS-29)
PROMIS-29 includes 29 items covering seven health domains-physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain interference-each measured with four items, plus a separate 0-10 numeric rating scale for pain intensity. Each health domain is assessed with questions on a 1-5 scale, with the valence of 1 and 5 being dependent on the domain being assessed. PROMIS-29 domains are scored using T-scores, standardized to a mean of 50 and a standard deviation of 10 based on the U.S. general population. Higher scores indicate more of the concept being measured. However, whether a higher score reflects better or worse health depends on the domain.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks
Composite Autonomic Symptom Score-31 (COMPASS-31)
COMPASS-31 quantifies symptoms of autonomic dysfunction across six weighted domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. The 31 items yield a total score ranging from 0 to 100, with higher scores indicating greater severity of autonomic symptoms.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start19 Mar 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael H Kaplan, Icahn School of Medicine at Mount Sinai
- Investigators
- Michael Kaplan, MD, Principal investigator, Mount Sinai Hospital, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423377
- Sponsor's protocol ID
- STUDY-25-01272
- Acronym
- VIPR
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.