Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

NCT05004194 | Completed

• 1 other identifier: GCO 20-2730
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scale (NRS)

  Change in average diary pain scores assessed by daily report on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale range from 0-10, higher score indicates more pain.

  baseline and 1 week after VCS

Secondary Outcomes (11)

• Acute change in NRS

  baseline and 5, 15 and 30 minutes after VCS

• Percentage of participants with NRS pain scores >= to 30% and 50%

  30 minutes, 24 hours, 1 week, 2 weeks after VCS

• Patient Global Impression of Change (PGIC)

  at 1 weeks, 2 weeks and 4 weeks after VCS

• Change in Multidimensional Assessment of Fatigue (MAF)

  baseline and at 1, 2 and 4 weeks after VCS

• Michigan Neuropathy Screening Instrument (MNSI)

  baseline and at 1, 2 and 4 weeks after VCS

Study Arms (1)

Cold water caloric stimulation

EXPERIMENTAL

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

Procedure: Vestibular Caloric Stimulation

Interventions

Vestibular Caloric Stimulation PROCEDURE

Irrigation of the right external ear canal

Also known as: VCS, Cold water caloric stimulation

Cold water caloric stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ioannis Tassiulas, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Rheumatology

Model Details: An open label non-randomized pilot trial

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 13, 2021
• Study Start: March 19, 2021
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)