Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Tympanometry Data [Срок оценки: Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.]
• Audiometry Data [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

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

Публикации

• 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

Идентификаторы

NCT: NCT07639775 · IRB-FY25-26-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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