Vestibular Innovation in Pain 2

Official title

Vestibular Innovation in Pain: A Randomized Controlled Trial

Overview

Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe \& cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain \& improving quality of life using validated patient-reported outcomes.

Interventions

• Procedure Vestibulocortical Stimulation
  VCS is a non-invasive bedside procedure using temperate water, and a plastic syringe (no needles). With the participant laying supine, temperate water is irrigated into the external ear canal at 1-2 cc/second.

Primary outcome measures

• Change in Pain numeric rating scale (NRS) [Time frame: Baseline and 1 week]

Secondary outcome measures (6)

• Change in Pain numeric rating scale (NRS) [Time frame: 30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks]
• Overall Well Being Scale [Time frame: 30 minutes]
• Patient Global Impression of Change (PGIC) [Time frame: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks]
• Brief Pain Inventory (Short-Form; BPI-SF) [Time frame: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks]
• Patient Reported Outcomes Measurement Information System (PROMIS-29) [Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks]
• Composite Autonomic Symptom Score-31 (COMPASS-31) [Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks]

Eligibility criteria

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
• Fluency in English
• Diagnosis of Fibromyalgia (FM)

• Diagnosis by American College of Rheumatology 2016 questionnaire
• Pain score 4/10 or more and less than 10/10 on the numeric rating scale at the time of inclusion.

Exclusion criteria

• History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or "ear tubes," and/or cochlear implant.
• Right ear infection within the last 3 months, or current right ear pain.
• Current pregnancy
• Bipolar Disorder
• History of seizures (including non-epileptiform seizures)
• History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke)
• Inability to lay supine for 15 minutes
• Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia.
• Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study.
• History of or current Meniere's Disease
• History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months
• History of hospitalization for severe hypertension
• History of vestibular schwannoma or meningioma resection.
• Patients taking opioid therapy (not including tramadol).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Mount Sinai West — New York

Identifiers

NCT: NCT07423377 · STUDY-25-01272

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗