Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media

Part of paid clinical trials in Lynchburg, Virginia.

Sponsor
Sarah Vidal
Study ID
NCT07639775
Status
Not Yet Recruiting

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Conditions

  • Osteopathic Manipulative Treatment (OMT)
  • Otitis Media
  • Otitis Media Chronic
  • Otitis Media Effusion
  • Otitis Media Recurrent
  • Otitis Media With Effusion in Children
  • Otitis Media in Children
  • Tympanostomy Tube Insertion

Eligibility Criteria

Sex
ALL
Age
6 Months - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Distal Region OMT Only
    Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.
  • Other: Intermediate Group: Distal Region OMT then Targeted OMT
    Participants assigned to this group receive a combination of the control OMT protocol followed by the experimental OMT protocol.
  • Other: Intermediate Group: Targeted OMT then Distal Region OMT
    Participants assigned to this group receive a combination of the experimental OMT protocol followed by the control OMT protocol.
  • Experimental: Targeted OMT Only
    Participants assigned to this group receive a double dose of the experimental OMT protocol.

Primary Outcome Measure

Final Surgical Decision [ Time Frame: At the time of the participant's pre-operative ENT visit, following all four study visits. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Blue Ridge Ear, Nose and ThroatLynchburgVirginia24501
Sarah Vidal, B.S.
[email protected]
8137200207
Jay Cline, M.D. (SUB_INVESTIGATOR)
Collaborative HealthplexLynchburgVirginia24502
Sarah Vidal
[email protected]
8137200207
Mark D Unger, DO, MS (SUB_INVESTIGATOR)
Joy Palmer, DO (SUB_INVESTIGATOR)
Kirsten Madea, DO (SUB_INVESTIGATOR)

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