Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
6 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mark D Unger, D.O., M.S.
- Número de telefone: 434-582-2773
- E-mail: mdunger@liberty.edu
Estude backup de contato
- Nome: Sarah Vidal, B.S.
- Número de telefone: 8137200207
- E-mail: sstephens72@liberty.edu
Locais de estudo
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Virginia
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Lynchburg, Virginia, Estados Unidos, 24501
- Blue Ridge Ear, Nose and Throat
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Contato:
- Sarah Vidal, B.S.
- Número de telefone: 8137200207
- E-mail: sstephens72@liberty.edu
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Subinvestigador:
- Jay Cline, M.D.
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Lynchburg, Virginia, Estados Unidos, 24502
- Collaborative Healthplex
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Contato:
- Sarah Vidal
- Número de telefone: 8137200207
- E-mail: sstephens72@liberty.edu
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Subinvestigador:
- Mark D Unger, DO, MS
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Subinvestigador:
- Joy Palmer, DO
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Subinvestigador:
- Kirsten Madea, DO
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Distal Region OMT Only
Participants assigned to this group receive a double dose of the 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.
|
|
Outro: 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.
|
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.
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.
Outros nomes:
|
|
Outro: 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.
|
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.
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.
Outros nomes:
|
|
Experimental: Targeted OMT Only
Participants assigned to this group receive a double dose of the experimental 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Final Surgical Decision
Prazo: 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.
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At the time of the participant's pre-operative ENT visit, following all four study visits.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tympanometry Data
Prazo: 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".
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Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
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Audiometry Data
Prazo: 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.
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Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
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Otitis Media Quality of Life Survey (OM-6)
Prazo: 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.
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This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
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Pediatric Quality of Life Inventory (PedsQL)
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
31 de maio de 2028
Conclusão do estudo (Estimado)
31 de maio de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de junho de 2026
Primeira postagem (Real)
10 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-FY25-26-44
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Only designated research personnel will have access to identifiable participant data.
For the purposes of data analysis, the information will be de-identified.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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