Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media

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

Overview

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.

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.

Primary outcome measures

• Final Surgical Decision [Time frame: At the time of the participant's pre-operative ENT visit, following all four study visits.]

Secondary outcome measures (4)

• 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.]
• 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.]
• 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.]
• 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.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Blue Ridge Ear, Nose and Throat — Lynchburg
• Collaborative Healthplex — Lynchburg

Publications

• Carreiro JE. An Osteopathic Approach to Children. 2nd ed. Churchill Livingstone; 2009.
• Kim 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 40481343
• Mills 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 12963590

Identifiers

NCT: NCT07639775 · IRB-FY25-26-44

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗