Vestibular Innovation in Pain 2 (VIPR)

Vestibular Innovation in Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia; Nociplastic Pain
• Intervention / Treatment: Procedure: Vestibulocortical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Talia Torkian; Phone Number: 212-241-1671; Email: viptrial@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West
      • Principal Investigator: Michael Kaplan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vestibulocortical Stimulation; Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.	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.; Other Names: VCS
Sham Comparator: Sham Stimulation; Participants will receive 50 cc of either warm or cold water irrigated into the right external ear canal at 1-2 cc/second.	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.; Other Names: VCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain numeric rating scale (NRS)	Change in NRS as compared to baseline. Pain numeric rating scale (NRS), Full score on scale from 0-10 (0 = no pain; 10 = pain as bad as you can imagine). Higher scores indicate more pain.	Baseline and 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain numeric rating scale (NRS)	Change in Pain numeric rating scale (NRS) (acute and long term). Pain numeric rating scale (NRS), Full score on scale from 0-10. 0 = no pain; 10 = pain as bad as you can imagine. Higher scores indicate more pain.	30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks
Overall Well Being Scale	Numeric rating scale scored from 0-10, 0 = lowest quality of life, 10 = best imaginable. Higher score indicates better health outcomes.	30 minutes
Patient Global Impression of Change (PGIC)	Full scale scored from 0-7 scale. 0 = No change or condition has worsened; 7 = A great deal better with considerable improvement. Higher score indicates better health outcomes.	24 hr, 1 week, 2 weeks, 3 weeks, 4 weeks
Brief Pain Inventory (Short-Form; BPI-SF)	Validated patient reported outcome that measures both pain intensity and pain interference. The BPI-SF uses numeric rating scales (0-10) to evaluate worst, least, average, and current pain intensity, as well as pain interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Pain intensity, Subscale scored from 0-10 NRS: 0 = no pain, 10 = worst pain imaginable. Pain interference, Subscale scored from 0-10 NRS: 0= Does not interfere, 10 = Completely interferes.	24 hrs, 1 week, 2 weeks, 3 weeks, 4 weeks
Patient Reported Outcomes Measurement Information System (PROMIS-29)	PROMIS-29 includes 29 items covering seven health domains-physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain interference-each measured with four items, plus a separate 0-10 numeric rating scale for pain intensity. Each health domain is assessed with questions on a 1-5 scale, with the valence of 1 and 5 being dependent on the domain being assessed. PROMIS-29 domains are scored using T-scores, standardized to a mean of 50 and a standard deviation of 10 based on the U.S. general population. Higher scores indicate more of the concept being measured. However, whether a higher score reflects better or worse health depends on the domain.	1 week, 2 weeks, 3 weeks, 4 weeks
Composite Autonomic Symptom Score-31 (COMPASS-31)	COMPASS-31 quantifies symptoms of autonomic dysfunction across six weighted domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. The 31 items yield a total score ranging from 0 to 100, with higher scores indicating greater severity of autonomic symptoms.	1 week, 2 weeks, 3 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Michael Kaplan, MD, Mount Sinai Hospital, Icahn School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pain; quality of life
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Fibromyalgia; Nociplastic Pain
• Other Study ID Numbers: STUDY-25-01272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified individual participant data will not be made available because participants did not provide consent for data sharing beyond the scope of the present study. Aggregate data supporting the findings are included in the article.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No