Vestibular Innovation in Pain 2
Recruiting · NCT07423377 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Mount Sinai West - New York, New York, United States