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New treatment option for Fibromyalgia
Official title Vestibular Innovation in Pain 2
ClinicalTrials.gov ID: NCT07423377
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.