Vestibular Innovation in Pain: A Randomized Controlled Trial
Icahn School of Medicine at Mount Sinai
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 membra…
Interventions
- ProcedureVestibulocortical 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.
Location
- Mount Sinai WestNew York, New York