Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial
1 other identifier
interventional
200
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
June 10, 2026
June 1, 2026
1.8 years
June 2, 2026
June 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Final Surgical Decision
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 Outcomes (4)
Tympanometry Data
Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Audiometry Data
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)
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)
This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
Study Arms (4)
Distal Region OMT Only
PLACEBO COMPARATORParticipants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.
Intermediate Group: Distal Region OMT then Targeted OMT
OTHERParticipants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol.
Intermediate Group: Targeted OMT then Distal Region OMT
OTHERParticipants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol.
Targeted OMT Only
EXPERIMENTALParticipants assigned to this group receive a double dose of the experimental OMT protocol.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sarah Vidallead
- KR Love Quantitative Consulting and Collaborationcollaborator
Study Sites (2)
Blue Ridge Ear, Nose and Throat
Lynchburg, Virginia, 24501, United States
Collaborative Healthplex
Lynchburg, Virginia, 24502, United States
Related Publications (3)
Carreiro JE. An Osteopathic Approach to Children. 2nd ed. Churchill Livingstone; 2009.
BACKGROUNDKim CH, McCray LR, Nguyen SA, Shermetaro C, Robbins WK. Use of osteopathic manipulation techniques for management of acute otitis media in pediatric patients: a scoping review. Eur Arch Otorhinolaryngol. 2025 Nov;282(11):5519-5528. doi: 10.1007/s00405-025-09492-9. Epub 2025 Jun 6.
PMID: 40481343BACKGROUNDMills MV, Henley CE, Barnes LL, Carreiro JE, Degenhardt BF. The use of osteopathic manipulative treatment as adjuvant therapy in children with recurrent acute otitis media. Arch Pediatr Adolesc Med. 2003 Sep;157(9):861-6. doi: 10.1001/archpedi.157.9.861.
PMID: 12963590BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Fellow
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 10, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
Only designated research personnel will have access to identifiable participant data. For the purposes of data analysis, the information will be de-identified.