Vestibular Innovation in Pain

Icahn School of Medicine at Mount Sinai39 enrolled

Overview

The VIP trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (VCS) - a safe \& cost-effective bedside technique - in treating pain, fatigue \& related symptoms using validated patient-reported outcomes. Data from this trial will be used to guide optimized treatment protocols in future randomized controlled trials and help inform the implementation of VCS into standard clinical practice.

VCS is a form of non-invasive neuromodulation whereby cold water is irrigated into the external ear canal.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Fatigue Quality of Life

Interventions

Vestibulocortical StimulationOTHER

50cc of cold water (4℃) irrigated to the right external ear canal, at 1-2 cc/second, with the patient laying supine.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed and dated informed consent form * Age equal to or \>18 years old * Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure. * Owns or has access to a smart phone or computer to complete outcome measures * Diagnosis of one of the following: * Fibromyalgia (FM), with at least a 4/10 average baseline pain on the numeric rating scale at the time of inclusion. * Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) * Long-COVID * Post Treatment Lyme Disease Syndrome (PTLDS) Exclusion Criteria: An individual with any of the following criteria will be excluded from participation in this study: * History of tympanic membrane injury, rupture, or surgery * Including tympanostomy, or "ear tubes," and/or cochlear implant. * Ear infection within the last 3 months, or current ear pain. * Current pregnancy * Bipolar Disorder * History of seizures (including non-epileptiform seizures) * History of syncope * Inability to lay supine for 30 minutes * Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study * Not fluent in English * History of or current Meniere's Disease * History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last three months * History of hospitalization for severe hypertension * History of vestibular schwannoma or meningioma resection.

Locations (1)

Mount Sinai West

New York, New York, United States

Outcomes

Primary Outcomes

Change in Diary pain numeric rating scale (Pain NRS) scores

Change in diary pain scores on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale from 0-10, with higher score indicating worse pain.

Time frame: Baseline and at 1 week after VCS

Secondary Outcomes

Acute and Longitudinal Change in numeric rating scale (Pain NRS)

Pain scores on an 11 point numeric rating scale at 30 minutes, 2 weeks, and 4 weeks after VCS as compared to baseline. Full scale from 0-10, with higher score indicating worse pain.

Time frame: Baseline and at 30 minutes, 24 hours, 2 weeks, and 4 weeks

Percentage of Patients with Numeric Rating Scale (NRS) pain scores > = to 30% and 50%

Percentage of patients with change in pain assessed by NRS pain scores \> equal to 30% and 50%. NRS full scale from 0-10, with higher score indicating worse pain.

Time frame: 30 minutes, 24 hours, 1 week, 2 weeks, 4 weeks

Brief Pain Inventory- Short Form

A 9-item instrument. Question 2 which is a diagram and question 7 which asks about medications, will be excluded. Total score from 0 to 10, with higher score indicating worse outcomes.

Time frame: 24 hours

Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score

Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) measures seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and the ability to participate in social roles and activities. Each domain has 4 questions ranked on a 5-point scale, and refer to the 7 previous days except physical function which has not time frame. Scoring is standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate poorer health outcomes for anxiety, depression, fatigue, ability to participate in social roles and activities, and pain interference domains. Lower scores reflect worse outcomes for physical function and sleep disturbances domains.

Data from ClinicalTrials.gov

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