Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

Mount Sinai Health System

Status

Completed

Conditions

Fibromyalgia

Treatments

Procedure: Vestibular Caloric Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05004194

GCO 20-2730

Details and patient eligibility

About

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.

Full description

This is an open label pilot study testing the potential therapeutic efficacy of vestibulocortical stimulation via cold water calorics in fibromyalgia. The trial will entail 6 weeks of total involvement for each participant including 3 weeks of active participation, with 4 weeks follow up: the irrigation happens at the beginning of week 2, so 4 weeks later is week 6.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 18 years old with ability to comprehend and consent to protocol.
Diagnosis of fibromyalgia by American College of Rheumatology (ACR) criteria (questionnaire).
At least a 4/10 baseline on the visual analogue pain scale (VAS).
Stable fibromyalgia medications for at least 4 weeks.
Owns or has access to a smart phone or computer to complete outcome measures.

Exclusion criteria

Use of opioids
Otitis externa or media within the past six months.
Current ear pain with or without other symptoms of otitis externa.
History of tympanic membrane rupture or surgery.
Current pregnancy.
Inability to lay supine for 30 minutes.
Limited decision making capacity.
Engaged in litigation, currently or prior, related to FMS.
Inability to commute to clinic once.
Primary language not English.
Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study
Treatment with the medication meclizine for vertigo
History of seizures
Diagnosis of bipolar disorder (treated or untreated)