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Behavioural Intervention

Cold water caloric stimulation for Fibromyalgia

N/A
Waitlist Available
Led By Ioannis Tassiulas, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 weeks, 2 weeks and 4 weeks after vcs
Awards & highlights

Summary

The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. The food and drug administration (FDA) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. Accordingly, there exists a need for novel therapeutics. The researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (VCS). VCS, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. VCS is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. There currently exists limited data on the topic, only case reports and case series. Given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.

Eligible Conditions
  • Fibromyalgia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 1, 2 and 4 weeks after vcs
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 1, 2 and 4 weeks after vcs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Numeric Rating Scale (NRS)
Secondary outcome measures
Acute change in NRS
Change in Brief Pain Inventory Short Form 36 (BPI SF36)
Change in Fibromyalgia Impact Questionnaire (FIQ)
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cold water caloric stimulationExperimental Treatment1 Intervention
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vestibular Caloric Stimulation
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
886 Previous Clinical Trials
535,022 Total Patients Enrolled
2 Trials studying Fibromyalgia
26 Patients Enrolled for Fibromyalgia
Ioannis Tassiulas, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
~5 spots leftby Sep 2025