An interventional study of Experimental Osteopathic Manipulative Treatment (OMT) Protocol and Control Osteopathic Manipulative Treatment (OMT) Protocol in Otitis Media, Otitis Media Effusion and Otitis Media Recurrent, sponsored by Sarah Vidal. Not yet recruiting at 2 sites in United States. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Sarah Vidal · Not applicable, Interventional, and Treatment
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:
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →This is the only study on the registry with Sarah Vidal as lead sponsor.
Compared within Otitis Media with Effusion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Otitis Media. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.
Other: Control Osteopathic Manipulative Treatment (OMT) Protocol
Participants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol.
Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol · Other: Control Osteopathic Manipulative Treatment (OMT) Protocol
Participants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol.
Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol · Other: Control Osteopathic Manipulative Treatment (OMT) Protocol
Participants assigned to this group receive a double dose of the experimental OMT protocol.
Other: 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.
Also known as: True Intervention
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.
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.
Time frame: At the time of the participant's pre-operative ENT visit, following all four study visits.
Tympanometry Data
Objective measurement of fluid and/or pressure behind the tympanic membrane. Results reported as "Type A", "B", or "C".
Time frame: Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Audiometry Data
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.
Time frame: 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.
Time frame: 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.
Time frame: This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.
Plan to share: No — Only designated research personnel will have access to identifiable participant data. For the purposes of data analysis, the information will be de-identified.
Start is estimated for Aug 2026; primary completion for May 2028, 21 months later.
Of 16 interventional studies with no phase under Otitis Media with Effusion, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 65. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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