Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study

Conditions
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Fibromyalgia

Intervention / Treatment
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* Procedure: Vestibular Caloric Stimulation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: An open label non-randomized pilot trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold water caloric stimulation<br>50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant. | Procedure: Vestibular Caloric Stimulation<br>* Irrigation of the right external ear canal<br>* Other names: Cold water caloric stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute change in NRS | Acute effect of VCS assessed by acute change in pain scores post VCS 5, 15 and 30 minutes post irrigation compared to baseline. Full scale range from 0-10, higher score indicates more pain. | baseline and 5, 15 and 30 minutes after VCS | 
| Percentage of participants with NRS pain scores >= to 30% and 50% | Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%. | 30 minutes, 24 hours, 1 week, 2 weeks after VCS | 
| Patient Global Impression of Change (PGIC) | Full score from 0-7, with higher score indicating more improvement. | at 1 weeks, 2 weeks and 4 weeks after VCS | 
| Change in Multidimensional Assessment of Fatigue (MAF) | MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue. | baseline and at 1, 2 and 4 weeks after VCS | 
| Michigan Neuropathy Screening Instrument (MNSI) | 15 yes or no questions - full score from 0-13, with higher score indicating more neuropathic symptoms. | baseline and at 1, 2 and 4 weeks after VCS | 
| Change in Brief Pain Inventory Short Form 36 (BPI SF36) | A 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes. Will exclude question 2 which is a diagram and question 7 which asks about medications. | baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS | 
| Change in Fibromyalgia Impact Questionnaire (FIQ) | Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome. | baseline and at 1, 2 and 4 weeks after VCS | 
| Change in Numeric Rating Scale (NRS) for pain in different regions of the body | Pain measured on a numeric rating scale in different regions of the body: the left upper extremity, right upper extremity, left lower extremity, right lower extremity, front of torso, back of torso, head/neck. Full scale range from 0-10, higher score indicates more pain. | baseline and at 24 hours, 1 week, 2 week, 4 week after VCS | 
| VCS Tolerability Survey | A seventeen question tolerability instrument developed specifically for caloric stimulation to assess tolerability by measuring the frequency and intensity of headaches, nausea, and vertigo. the tolerability scale does not have a total score just individual questions re headache nausea vertigo discomfort and grades intensities rated on a 0-10 scale, higher numbers reflecting higher severity of symptoms. | 24 hours post VCS | 
| Number of participants willing to trial VCS again | Number of participants expressing willingness to trial VCS again | 24 hours post VCS | 
| Change in Subjective Overall Well Being Scale | Subjective Overall Well Being Scale is a 11 point scale with full scale from 0-10, with higher score reflecting the best possible overall subjective disposition | at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative |