Osteopathic Manipulative Treatment for Ear Infections

Not yet recruiting at 1 trial location
MD
SV
Overseen BySarah Vidal, B.S.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Sarah Vidal

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

I am between 6 months and 7 years old.
I have been referred to an ENT doctor for ongoing or repeated ear infections.
There are at least 5 weeks between my enrollment and planned surgery decision.
See 1 more

Exclusion Criteria

I need urgent surgery as decided by my ENT doctor.
I have small pits or holes in front of my ears.
I have had ear tubes placed or currently have ear tubes.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a standardized OMT protocol or a placebo/control manual treatment once weekly for 4 weeks before the final surgical decision

4 weeks
4 visits (in-person)

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

1-2 weeks

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

Group I: Targeted OMT OnlyExperimental Treatment1 Intervention
Group II: Intermediate Group: Targeted OMT then Distal Region OMTExperimental Treatment2 Interventions
Group III: Intermediate Group: Distal Region OMT then Targeted OMTExperimental Treatment2 Interventions
Group IV: Distal Region OMT OnlyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sarah Vidal

Lead Sponsor

KR Love Quantitative Consulting and Collaboration

Collaborator

Trials
1
Recruited
70+