Clinical trial NCT05004194: Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia
Official title: Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open label non-randomized pilot trial
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Numeric Rating Scale (NRS)
timeFrame: baseline and 1 week after VCS
Secondary outcomes:
measure: Acute change in NRS
timeFrame: baseline and 5, 15 and 30 minutes after VCS
measure: Percentage of participants with NRS pain scores >= to 30% and 50%
timeFrame: 30 minutes, 24 hours, 1 week, 2 weeks after VCS
measure: Patient Global Impression of Change (PGIC)
timeFrame: at 1 weeks, 2 weeks and 4 weeks after VCS
measure: Change in Multidimensional Assessment of Fatigue (MAF)
timeFrame: baseline and at 1, 2 and 4 weeks after VCS
measure: Michigan Neuropathy Screening Instrument (MNSI)
timeFrame: baseline and at 1, 2 and 4 weeks after VCS
measure: Change in Brief Pain Inventory Short Form 36 (BPI SF36)
timeFrame: baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
measure: Change in Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: baseline and at 1, 2 and 4 weeks after VCS
measure: Change in Numeric Rating Scale (NRS) for pain in different regions of the body
timeFrame: baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
measure: VCS Tolerability Survey
timeFrame: 24 hours post VCS
measure: Number of participants willing to trial VCS again
timeFrame: 24 hours post VCS
measure: Change in Subjective Overall Well Being Scale
timeFrame: at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ioannis Tassiulas, MD
role: PRINCIPAL_INVESTIGATOR
References: