Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media

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.

Conditions

• Otitis Media
• Otitis Media Effusion
• Otitis Media Recurrent
• Otitis Media With Effusion in Children
• Otitis Media Chronic
• Otitis Media in Children
• Tympanostomy Tube Insertion
• Osteopathic Manipulative Treatment (OMT)

Interventions

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

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.

Sponsors & Collaborators

• KR Love Quantitative Consulting and Collaboration

  collaborator OTHER

• Sarah Vidal

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

6 Months

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• United States

Study Locations