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Hands-On therapy may spare kids from ear tube surgery

NCT ID NCT07639775

Symptom relief Sponsor: Sarah Vidal Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 osteopathic manipulative treatment (OMT) — a gentle, hands-on therapy — can reduce the need for ear tube surgery in children with chronic or recurrent ear infections. Two hundred children aged 6 months to 7 years will receive either OMT or a placebo manual treatment once a week for four weeks. The goal is to see if OMT improves ear drainage and function enough to avoid surgery.

What this could mean

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

Active substance
osteopathic manipulative treatment (OMT)
What this could lead to
If it works, this could offer a non-surgical option for children with chronic ear infections, potentially avoiding the need for ear tube surgery.
What could go wrong
This is an early-stage trial with no phase designation, and the placebo control may also show effects. The treatment is non-invasive, but results may not be strong enough to change surgical recommendations.

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 200 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2028

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

6 months to 6 years

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: * Age 6 months to less than 7 years. (All participants) * Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants) * Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants) * At least 5 weeks between enrollment and anticipated surgical decision point. (All participants) Exclusion Criteria: * Congenital or developmental conditions associated with increased otitis media risk, including but not limited to Down syndrome, cleft palate, or other craniofacial abnormalities. (All participants) * History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants) * History of tympanic membrane perforation. (All participants) * Presence of preauricular pits. (All participants) * Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)

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Conditions

The condition(s) this trial relates to.

chronic otitis media otitis media otitis media with effusion otitis media, susceptibility to serous glue ear

As listed by the trial registrant

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

Osteopathic manipulative treatment (OMT) Otitis media Otitis media chronic Otitis media effusion Otitis media in children Otitis media recurrent Otitis media with effusion in children Tympanostomy tube insertion

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Blue Ridge Ear, Nose and Throat

    Lynchburg, Virginia, 24501, United States

  • Collaborative Healthplex

    Lynchburg, Virginia, 24502, United States

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