Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media

June 6, 2026 updated by: Sarah Vidal

The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Blue Ridge Ear, Nose and Throat
        • Contact:
        • Sub-Investigator:
          • Jay Cline, M.D.
      • Lynchburg, Virginia, United States, 24502
        • Collaborative Healthplex
        • Contact:
        • Sub-Investigator:
          • Mark D Unger, DO, MS
        • Sub-Investigator:
          • Joy Palmer, DO
        • Sub-Investigator:
          • Kirsten Madea, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Distal Region OMT Only
Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.
Other: Control Osteopathic Manipulative Treatment (OMT) Protocol
The Control Intervention is a protocol of genuine OMT applied to the Sacrum, Pelvis and Lower Extremity body regions plus standard of care. This Control Intervention is conceptualized as inert in the study population.
Other: Intermediate Group: Distal Region OMT then Targeted OMT
Participants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol.
Other: Control Osteopathic Manipulative Treatment (OMT) Protocol
The Control Intervention is a protocol of genuine OMT applied to the Sacrum, Pelvis and Lower Extremity body regions plus standard of care. This Control Intervention is conceptualized as inert in the study population.
Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol
The Experimental Intervention is a standardized OMT protocol targeting the head, neck, thoracic, and lymphatic regions, selected to address anatomic and physiologic factors implicated in eustachian tube function, middle ear ventilation, and lymphatic drainage. The protocol consists of widely taught, non-invasive osteopathic techniques delivered in a fixed sequence and duration.
Other Names:
  • True Intervention
Other: Intermediate Group: Targeted OMT then Distal Region OMT
Participants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol.
Other: Control Osteopathic Manipulative Treatment (OMT) Protocol
The Control Intervention is a protocol of genuine OMT applied to the Sacrum, Pelvis and Lower Extremity body regions plus standard of care. This Control Intervention is conceptualized as inert in the study population.
Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol
The Experimental Intervention is a standardized OMT protocol targeting the head, neck, thoracic, and lymphatic regions, selected to address anatomic and physiologic factors implicated in eustachian tube function, middle ear ventilation, and lymphatic drainage. The protocol consists of widely taught, non-invasive osteopathic techniques delivered in a fixed sequence and duration.
Other Names:
  • True Intervention
Experimental: Targeted OMT Only
Participants assigned to this group receive a double dose of the experimental OMT protocol.
Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol
The Experimental Intervention is a standardized OMT protocol targeting the head, neck, thoracic, and lymphatic regions, selected to address anatomic and physiologic factors implicated in eustachian tube function, middle ear ventilation, and lymphatic drainage. The protocol consists of widely taught, non-invasive osteopathic techniques delivered in a fixed sequence and duration.
Other Names:
  • True Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final Surgical Decision
Time Frame: At the time of the participant's pre-operative ENT visit, following all four study visits.
Following the final intervention for any given participant, the ENT physician, in conjunction with the parent/guardian, will determine whether to proceed with tympanostomy tube placement, defer, or cancel based on clinical status. This decision constitutes the primary outcome of the study.
At the time of the participant's pre-operative ENT visit, following all four study visits.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tympanometry Data
Time Frame: Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Objective measurement of fluid and/or pressure behind the tympanic membrane. Results reported as "Type A", "B", or "C".
Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Audiometry Data
Time Frame: Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
An objective measurement of hearing ability in decibels, with the ability to distinguish between conductive and sensorineural hearing loss. Typically done in conjunction with tympanometry.
Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Otitis Media Quality of Life Survey (OM-6)
Time Frame: This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
A parent-proxy survey used for infants and young children. It tracks six core domains: physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns. The six items on OM-6 questionnaire are graded by caregiver on a seven-point scale where 1 indicates no problem and 7 indicates extreme problem. The individual scores are summed up and divided by 6 to get an overall mean score. Higher scores indicate worse outcome and lower scores indicate better outcome.
This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
The PedsQL Inventory is designed to measure health-related quality of life (HRQOL) in healthy children and those with acute or chronic health conditions. It is divided into specific age brackets to ensure developmentally appropriate questions. For participants 6 months to 2 years old, the PedsQL Infant Scales will be used. For participants 3 to 6 years old, the PedsQL 4.0 Generic Core Scales - Parent Proxy Report will be used. Parents/caregivers must complete these as proxy-reports. The PedsQL uses a standard 5-point Likert scale (0 = Never a problem; 1 = Almost never a problem; 2 = Sometimes a problem; 3 = Often a problem; 4 = Almost always a problem). Answers are reverse-scored and transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) and the mean is taken. Higher scores indicate a better outcome.
This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarah Vidal

Collaborators

KR Love Quantitative Consulting and Collaboration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 6, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY25-26-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only designated research personnel will have access to identifiable participant data. For the purposes of data analysis, the information will be de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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