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