Vestibular Innovation in Pain 2
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized controlled trial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- A blind-to-hypothesis approach will be used. Investigators and participants will not be blinded to temperature of water as the procedure itself does not lend to it.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Sham Comparator Sham Stimulation |
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second. |
|
Recruiting Locations
Mount Sinai West
New York, New York 10019
New York, New York 10019
More Details
- Status
- Recruiting
- Sponsor
- Icahn School of Medicine at Mount Sinai