Vestibulocortical Stimulation for Fibromyalgia
(VIPR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to help people with fibromyalgia, a condition causing widespread pain. The researchers aim to determine if vestibulocortical stimulation (VCS), which involves gently rinsing the ear canal with water, can quickly reduce pain and improve quality of life. This technique is part of the Vestibular Innovation in Pain 2 study. Participants will receive either this water treatment or a similar procedure for comparison. Individuals diagnosed with fibromyalgia who experience significant daily pain may be well-suited for this study. As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to new pain relief methods.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking opioid therapy (except tramadol).
What prior data suggests that vestibulocortical stimulation is safe for fibromyalgia patients?
Research has shown that vestibulocortical stimulation (VCS) is generally safe and well-tolerated. This procedure involves gently rinsing the outer ear canal with warm or cold water. Studies have found that VCS can help reduce pain and improve overall well-being in people with fibromyalgia. In a trial where both researchers and participants knew the treatment given, VCS relieved pain and improved quality of life without causing significant side effects. These findings suggest that VCS may offer a promising option for those seeking pain relief from fibromyalgia.12345
Why are researchers excited about this trial?
Researchers are excited about vestibulocortical stimulation for fibromyalgia because it offers a novel approach by targeting the vestibular system, which is not typically addressed in current treatments like medication, physical therapy, or cognitive-behavioral therapy. This method involves irrigating the ear with warm or cold water, potentially providing a non-invasive way to alleviate pain. Unlike most fibromyalgia treatments that focus on managing symptoms, this technique could directly influence brain areas involved in pain perception, offering a fresh perspective on managing this challenging condition.
What evidence suggests that vestibulocortical stimulation is effective for fibromyalgia?
Studies have shown that vestibulocortical stimulation (VCS) can quickly reduce pain in people with fibromyalgia. In some research, 82.4% of participants felt less pain just 30 minutes after the treatment. After 24 hours, 41% of patients reported at least a 30% reduction in pain, and 37% noticed at least a 50% improvement in their symptoms. This trial will provide participants with either VCS or a sham stimulation to evaluate its effectiveness. These findings suggest that VCS might help ease pain and improve the quality of life for those with fibromyalgia.12356
Who Is on the Research Team?
Michael Kaplan, MD
Principal Investigator
Mount Sinai Hospital, Icahn School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults (18+) diagnosed with fibromyalgia who have moderate to severe pain (pain score between 4 and 10), can use a smartphone or computer, speak English, and are willing to try the ear canal water procedure and complete online surveys.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single session of vestibulocortical stimulation (VCS) or sham stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vestibular Innovation in Pain 2
Trial Overview
The study tests whether vestibulocortical stimulation—gently rinsing the outer ear canal with temperate water using a syringe—can quickly reduce pain and improve quality of life in people with fibromyalgia compared to a placebo treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Citations
NCT07423377 | Vestibular Innovation in Pain 2
The VIPR trial will assess the efficacy of a single session of VCS - a safe & cost-effective bedside technique using a plastic syringe and ...
Vestibular Innovation in Pain 2
Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and ...
Study Details | NCT06559839 | Vestibular Innovation in Pain
The VIP trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (VCS) - a safe ...
Pain relief in refractory fibromyalgia after vestibulocortical ...
Pain relief in refractory fibromyalgia after vestibulocortical stimulation: an open-label pilot trial. Pain Med. 2024 Mar 1;25(3):252-254.
Vestibulocortical Stimulation for Fibromyalgia (VIPR Trial)
The VIPR trial will assess the efficacy of a single session of VCS - a safe \& cost-effective bedside technique using a plastic syringe and ...
Vestibular Innovation in Pain 2 | NCT07423377
Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain ...
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