Fibromyalgia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are aged 18 years or older
- People who have been diagnosed with Fibromyalgia using the American College of Rheumatology 2016 questionnaire
- People whose pain level is rated at 4 out of 10 or higher, but less than 10 out of 10, at the time of joining the trial
- People who are interested in and willing to receive the study treatment (VCS) and to complete online surveys before and after the procedure
- People who own or have access to a smartphone or computer to complete the required surveys
- People who are fluent in English
- People who are willing to sign and date a consent form for the study
Who may not be able to join:
- People who have had an injury, rupture, or surgery involving the eardrum, including ear tubes (tympanostomy) or a cochlear implant
- People who have had an infection in their right ear in the past 3 months, or who currently have right ear pain
- People who are currently pregnant
- People who have been diagnosed with Bipolar Disorder
- People who have a history of seizures of any kind
- People who have fainted (lost consciousness) in the last 3 months — note: feeling faint without losing consciousness is not included (confirm with trial site)
- People who are unable to lie flat on their back for 15 minutes
- People who are currently receiving disability benefits related to fibromyalgia, or who are involved in any legal proceedings related to fibromyalgia
- People with significant medical, psychological, or behavioural conditions that the trial investigators consider would affect safe participation in the study
- People who have a history of or currently have Meniere's Disease (an inner ear condition)
- People who have had a heart attack, stroke, mini-stroke (TIA), or heart bypass surgery (CABG) within the last 3 months
- People who have previously been hospitalised for severely high blood pressure
- People who have had surgery to remove a vestibular schwannoma or meningioma (certain types of tumours near the ear or brain)
- People who are currently taking opioid-based pain medications (tramadol is not included in this restriction)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Michael Kaplan, MD, Mount Sinai Hospital, Icahn School of Medicine
Phone: 212-241-1671
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in Pain numeric rating scale (NRS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.