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Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media

6. juni 2026 oppdatert av: Sarah Vidal

The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Virginia
      • Lynchburg, Virginia, Forente stater, 24501
        • Blue Ridge Ear, Nose and Throat
        • Ta kontakt med:
        • Underetterforsker:
          • Jay Cline, M.D.
      • Lynchburg, Virginia, Forente stater, 24502
        • Collaborative Healthplex
        • Ta kontakt med:
        • Underetterforsker:
          • Mark D Unger, DO, MS
        • Underetterforsker:
          • Joy Palmer, DO
        • Underetterforsker:
          • Kirsten Madea, DO

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Distal Region OMT Only
Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.
Annen: Control 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.
Annen: 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.
Annen: Control 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.
Annen: 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.
Andre navn:
  • True Intervention
Annen: 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.
Annen: Control 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.
Annen: 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.
Andre navn:
  • True Intervention
Eksperimentell: Targeted OMT Only
Participants assigned to this group receive a double dose of the experimental OMT protocol.
Annen: 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.
Andre navn:
  • True Intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Final Surgical Decision
Tidsramme: 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.
At the time of the participant's pre-operative ENT visit, following all four study visits.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tympanometry Data
Tidsramme: 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".
Performed at the inital ENT consultation as standard of care, and again at the time of the pre-operative ENT visit.
Audiometry Data
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
This survey will be administered at Week 1, Week 3 (study midpoint) and within one week of the participant's pre-operative ENT appointment.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sarah Vidal

Samarbeidspartnere

KR Love Quantitative Consulting and Collaboration

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

31. mai 2028

Studiet fullført (Antatt)

31. mai 2028

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

6. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-FY25-26-44

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Only designated research personnel will have access to identifiable participant data. For the purposes of data analysis, the information will be de-identified.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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