[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642730":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":40,"locations":50,"responsibleParty":84,"collaborators":87,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":39,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":39,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":39,"overallStatus":116,"whyStopped":39,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Liberty University","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Distal Region OMT Only","PLACEBO_COMPARATOR","Participants assigned to this group receive a double dose of the control osteopathic manipulative treatment (OMT) protocol.",[13],"Other: Control Osteopathic Manipulative Treatment (OMT) Protocol",{"label":15,"type":6,"description":16,"interventionNames":17},"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.",[18,13],"Other: Experimental Osteopathic Manipulative Treatment (OMT) Protocol",{"label":20,"type":6,"description":21,"interventionNames":22},"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.",[18,13],{"label":24,"type":25,"description":26,"interventionNames":27},"Targeted OMT Only","EXPERIMENTAL","Participants assigned to this group receive a double dose of the experimental OMT protocol.",[18],[29,35],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[15,20,24],[34],"True Intervention",{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"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.",[9,15,20],null,[41,46],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":45},"Mark D Unger, D.O., M.S.","CONTACT","434-582-2773","mdunger@liberty.edu",{"name":47,"role":43,"phone":48,"phoneExt":39,"email":49},"Sarah Vidal, B.S.","8137200207","sstephens72@liberty.edu",[51,69],{"facility":52,"status":39,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Blue Ridge Ear, Nose and Throat","Lynchburg","Virginia","24501","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-79.14225,37.41375,{"lat":62,"lon":61},[65,66],{"name":47,"role":43,"phone":48,"phoneExt":39,"email":49},{"name":67,"role":68,"phone":39,"phoneExt":39,"email":39},"Jay Cline, M.D.","SUB_INVESTIGATOR",{"facility":70,"status":39,"city":53,"state":54,"zip":71,"country":56,"countryCode":57,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"Collaborative Healthplex","24502",{"type":59,"coordinates":73},[61,62],{"lat":62,"lon":61},[76,78,80,82],{"name":77,"role":43,"phone":48,"phoneExt":39,"email":49},"Sarah Vidal",{"name":79,"role":68,"phone":39,"phoneExt":39,"email":39},"Mark D Unger, DO, MS",{"name":81,"role":68,"phone":39,"phoneExt":39,"email":39},"Joy Palmer, DO",{"name":83,"role":68,"phone":39,"phoneExt":39,"email":39},"Kirsten Madea, DO",{"type":85,"investigatorFullName":77,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","Research Fellow",[88],{"name":89,"class":6},"KR Love Quantitative Consulting and Collaboration","100642730","osteopathic-manipulative-treatment-for-children-with-chronic-or-recurrent-otitis-media-100642730",false,"NCT07639775","Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media","The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 6 months to less than 7 years. (All participants)\n* Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants)\n* Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants)\n* At least 5 weeks between enrollment and anticipated surgical decision point. (All participants)\n\nExclusion Criteria:\n\n* 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)\n* History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants)\n* History of tympanic membrane perforation. (All participants)\n* Presence of preauricular pits. (All participants)\n* Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)","ALL","6 Months","6 Years",{"count":101,"type":102},200,"ESTIMATED","INTERVENTIONAL",[105],"NA","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.\n\nThe main question it aims to answer is:\n\nCan 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?\n\nResearchers will compare children who receive the standardized OMT protocol with children who receive a placebo\u002Fcontrol manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery.\n\nParticipants will:\n\n* Attend 4 weekly study visits before their final ENT surgical decision.\n* 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.\n* Complete study-related assessments and questionnaires related to ear symptoms and quality of life.\n* Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.",[108,109,110,111,112,113,114,115],"Otitis Media","Otitis Media Effusion","Otitis Media Recurrent","Otitis Media With Effusion in Children","Otitis Media Chronic","Otitis Media in Children","Tympanostomy Tube Insertion","Osteopathic Manipulative Treatment (OMT)","NOT_YET_RECRUITING","2026-06-06",{"date":119,"type":120},"2026-06-10","ACTUAL",{"date":122,"type":102},"2026-08-01",{"date":124,"type":102},"2028-05-31",{"name":77,"class":6},2]