Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

NCT ID: NCT05004194

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2021-07-02

Brief 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.

Detailed 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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cold water caloric stimulation

50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.

Group Type: EXPERIMENTAL

Vestibular Caloric Stimulation

Intervention Type: PROCEDURE

Irrigation of the right external ear canal

Interventions

Vestibular Caloric Stimulation

Irrigation of the right external ear canal

Intervention Type: PROCEDURE

Other Intervention Names

VCS; Cold water caloric stimulation

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ioannis Tassiulas

Associate Professor of Medicine, Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ioannis Tassiulas, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 20-2730

Identifier Type: -

Identifier Source: org_study_id