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Could a simple ear rinse ease fibromyalgia pain?

NCT ID NCT07423377

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a non-invasive procedure called vestibulocortical stimulation (VCS) can reduce pain and improve quality of life in people with fibromyalgia. VCS involves gently irrigating the ear canal with temperate water using a plastic syringe. The trial will compare a single session of VCS to a sham procedure in 56 adults diagnosed with fibromyalgia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vestibulocortical stimulation (VCS) – a procedure using a plastic syringe to gently irrigate the ear canal with temperate water
What this could lead to
If it works, this could offer a simple, safe, and low-cost way to temporarily reduce pain and improve well-being for people with fibromyalgia.
What could go wrong
This is a small, early-stage trial with only 56 participants, testing a single session. The effect may be small or no better than a placebo, and long-term benefits are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

fibromyalgia Nociplastic Pain Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia Nociplastic pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

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