Osteopathic Manipulative Treatment (OMT), Otitis Media, Otitis Media Chronic, Otitis Media Effusion, Otitis Media in Children, Otitis Media Recurrent, Otitis Media With Effusion in Children, Tympanostomy Tube Insertion
Conditions
Brief summary
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
OTHERExperimental 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.
OTHERControl 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.
Sponsors
Sarah Vidal
KR Love Quantitative Consulting and Collaboration
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Surgical Decision | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tympanometry Data | 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". |
| Audiometry Data | 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. |
| Otitis Media Quality of Life Survey (OM-6) | 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. |
| Pediatric Quality of Life Inventory (PedsQL) | 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. |
Countries
United States
Contacts
CONTACTMark D Unger, D.O., M.S.
CONTACTSarah Vidal, B.S.
Outcome results
None listed