Vestibular Innovation in Pain 2

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vestibulocortical Stimulation

Treatment groups

56 Participants
are divided into 2 treatment groups

Locations

1
Mount Sinai West10019, New YorkNew York, United States

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor