Osteopathic Manipulative Treatment for Ear Infections
What You Need to Know Before You Apply
What is the purpose of this 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.
Are You a Good Fit for This Trial?
This trial is for children who have chronic or recurring ear infections and are being considered for ear tube surgery by an ENT specialist. Participants must be able to attend four weekly visits before a final decision about surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a standardized OMT protocol or a placebo/control manual treatment once weekly for 4 weeks before the final surgical decision
Follow-up
Participants continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended
What Are the Treatments Tested in This Trial?
Interventions
- Control Osteopathic Manipulative Treatment (OMT) Protocol
- Experimental Osteopathic Manipulative Treatment (OMT) Protocol
Trial Overview
The study compares two types of hands-on treatments: a standardized osteopathic manipulative treatment (OMT) protocol versus a control manual therapy, given once a week for four weeks, to see if OMT can reduce the need for ear tube surgery in kids.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants assigned to this group receive a double dose of the experimental OMT protocol.
Participants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol.
Participants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol.
Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarah Vidal
Lead Sponsor
KR Love Quantitative Consulting and Collaboration
Collaborator
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