An interventional study of Vestibulocortical Stimulation in Fibromyalgia and Nociplastic Pain, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 56 is close to the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of Fibromyalgia (FM)
Exclusion Criteria:
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Procedure: Vestibulocortical Stimulation
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
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.
Also known as: VCS
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.
Time frame: Baseline and 1 week
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks
Plan to share: 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.
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Icahn School of Medicine at Mount Sinai