Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
6 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mark D Unger, D.O., M.S.
- Numéro de téléphone: 434-582-2773
- E-mail: mdunger@liberty.edu
Sauvegarde des contacts de l'étude
- Nom: Sarah Vidal, B.S.
- Numéro de téléphone: 8137200207
- E-mail: sstephens72@liberty.edu
Lieux d'étude
-
-
Virginia
-
Lynchburg, Virginia, États-Unis, 24501
- Blue Ridge Ear, Nose and Throat
-
Contact:
- Sarah Vidal, B.S.
- Numéro de téléphone: 8137200207
- E-mail: sstephens72@liberty.edu
-
Sous-enquêteur:
- Jay Cline, M.D.
-
Lynchburg, Virginia, États-Unis, 24502
- Collaborative Healthplex
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Contact:
- Sarah Vidal
- Numéro de téléphone: 8137200207
- E-mail: sstephens72@liberty.edu
-
Sous-enquêteur:
- Mark D Unger, DO, MS
-
Sous-enquêteur:
- Joy Palmer, DO
-
Sous-enquêteur:
- Kirsten Madea, DO
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur 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.
|
|
Autre: 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.
Autres noms:
|
|
Autre: 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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Final Surgical Decision
Délai: 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.
|
At the time of the participant's pre-operative ENT visit, following all four study visits.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tympanometry Data
Délai: 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".
|
Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
|
|
Audiometry Data
Délai: 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.
|
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)
Délai: 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.
|
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)
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 mai 2028
Achèvement de l'étude (Estimé)
31 mai 2028
Dates d'inscription aux études
Première soumission
2 juin 2026
Première soumission répondant aux critères de contrôle qualité
6 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies oto-rhino-laryngologiques
- Maladies de l'oreille
- Otite
- Otite moyenne
- Otite moyenne avec épanchement
- Qualité des soins de santé, accès et évaluation
- Thérapeutique
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Caractéristiques de l'étude épidémiologique
- Protocoles cliniques
Autres numéros d'identification d'étude
- IRB-FY25-26-44
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Only designated research personnel will have access to identifiable participant data.
For the purposes of data analysis, the information will be de-identified.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .