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NCT Number: NCT07423377

Vestibular Innovation in Pain 2

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai West

New York, 10019, United States

Location status: Recruiting

Location contact

Michael Kaplan

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vestibulocortical Stimulation

Procedure

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

Primary outcomes

  1. Change in Pain numeric rating scale (NRS)

    Time frame: Baseline and 1 week

    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.

Secondary outcomes

  1. Change in Pain numeric rating scale (NRS)

    Time frame: 30 minutes, 24 hours, 2 weeks, 3 weeks, 4 weeks

    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.

  2. Overall Well Being Scale

    Time frame: 30 minutes

    Numeric rating scale scored from 0-10, 0 = lowest quality of life, 10 = best imaginable. Higher score indicates better health outcomes.

  3. Patient Global Impression of Change (PGIC)

    Time frame: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks

    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.

  4. Brief Pain Inventory (Short-Form; BPI-SF)

    Time frame: 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks

    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.

  5. Patient Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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.

  6. Composite Autonomic Symptom Score-31 (COMPASS-31)

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Talia Torkian

CONTACT

[email protected]

212-241-1671

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Vestibular Innovation in Pain: A Randomized Controlled Trial

Acronym: VIPR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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