NCT07423377 · Icahn School of Medicine at Mount Sinai
Vestibular Innovation in Pain 2
(VIPR)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Vestibulocortical Stimulation
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.
Primary outcome measures
Change in Pain numeric rating scale (NRS)
Time frame: Baseline and 1 week
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 severe hypertension
- History of vestibular schwannoma or meningioma resection.
- Patients taking opioid therapy (not including tramadol).
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations