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| Name | Class |
|---|---|
| KR Love Quantitative Consulting and Collaboration | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal Region OMT Only | Placebo Comparator | Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol. |
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| Intermediate Group: Distal Region OMT then Targeted OMT | Other | Participants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol. |
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| Intermediate Group: Targeted OMT then Distal Region OMT | Other | Participants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol. |
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| Targeted OMT Only | Experimental | Participants assigned to this group receive a double dose of the experimental OMT protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Osteopathic Manipulative Treatment (OMT) Protocol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Final Surgical Decision | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tympanometry Data | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark D Unger, D.O., M.S. | Contact | 434-582-2773 | mdunger@liberty.edu | |
| Sarah Vidal, B.S. | Contact | 8137200207 | sstephens72@liberty.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blue Ridge Ear, Nose and Throat | Lynchburg | Virginia | 24501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Carreiro JE. An Osteopathic Approach to Children. 2nd ed. Churchill Livingstone; 2009. | ||
| 40481343 | Background | 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. | |
| 12963590 |
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Only designated research personnel will have access to identifiable participant data. For the purposes of data analysis, the information will be de-identified.
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|
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| Control Osteopathic Manipulative Treatment (OMT) Protocol | Other | 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. |
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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) | 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) | 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. |
| Collaborative Healthplex | Lynchburg | Virginia | 24502 | United States |
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| Background |
| 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. |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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