Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
Public ClinicalTrials.gov record NCT07639775. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement. The main question it aims to answer is: Can a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media? Researchers will compare children who receive the standardized OMT protocol with children who receive a placebo/control manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery. Participants will: * Attend 4 weekly study visits before their final ENT surgical decision. * Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization. * Complete study-related assessments and questionnaires related to ear symptoms and quality of life. * Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.
Study identification
- NCT ID
- NCT07639775
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- Experimental Osteopathic Manipulative Treatment (OMT) Protocol Other
- Control Osteopathic Manipulative Treatment (OMT) Protocol Other
Other
Eligibility (public fields only)
- Age range
- 6 Months to 6 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2026
- Primary completion
- May 30, 2028
- Completion
- May 30, 2028
- Last update posted
- Jun 9, 2026
2026 – 2028
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Blue Ridge Ear, Nose and Throat | Lynchburg | Virginia | 24501 | — |
| Collaborative Healthplex | Lynchburg | Virginia | 24502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07639775, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 9, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07639775 live on ClinicalTrials.gov.