[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548681":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":58,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Cook Children's Health Care System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Massage Therapy Group","EXPERIMENTAL","Participants in the massage therapy group are treated by a certified pediatric massage therapist for at least two 30- minute massage therapy sessions performed on postoperative days two and four or five. Participants will continue to receive standard of care, including any pain medications as needed.",[13],"Other: Massage Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Participants in control group will continue to receive the normal standard of care as usual for their recovery and will be monitored by hospital staff in obtaining the same data points recorded clinically for post-op days 2 and 4\u002F5; however, no therapeutic intervention will occur.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Massage Therapy","Massage therapy (MT) has been proven as an alternative non-opioid pain management intervention, particularly towards reducing pain, diminishing depression, improving immune function, and increasing alertness in the adult population. MT raises the temperature of local tissues, dilates capillaries, accelerates the circulation of blood and lymph, promotes the absorption of local tissue metabolism and mass inflammation, improves the nutritional supply of surrounding muscle groups, promotes their growth and development, and relieves pain.",[9],[25],{"name":26,"affiliation":5,"role":27},"Meredith Brooks, MD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Throy Campbell, PhD","CONTACT","682-885-1044","throy.campbell@cookchildrens.org",{"name":35,"role":31,"phone":32,"phoneExt":18,"email":36},"Kristy Reyes","kristy.reyes@cookchildrens.org",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Cook Children's Medical Center","RECRUITING","Fort Worth","Texas","76104","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-97.32085,32.72541,{"lat":50,"lon":49},[53,57],{"name":54,"role":31,"phone":55,"phoneExt":18,"email":56},"Laurie Bailey, PhD","682-885-2488","laurie.bailey@cookchildrens.org",{"name":26,"role":27,"phone":18,"phoneExt":18,"email":18},{"type":59,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100548681","massage-therapy-after-thoracic-or-lumbar-surgery-100548681",false,"NCT06424158","Massage Therapy After Thoracic or Lumbar Surgery","The Impact of Massage Therapy on Post-Surgical Pain, Anxiety, Quality of Life, and Opioid Analgesia Exposure on Children After Thoracic or Lumbar Surgery","Inclusion Criteria:\n\n* Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery\n* Able to participate and perform in a massage therapy as a recovery option\n* Participant needs to be verbal\n* Ability to understand study procedures and to comply with them for the entire length of the study\n\nExclusion Criteria:\n\n* Prospective patients scheduled to undergo any spinal fusion other than a thoracic or lumbar spinal fusion surgery.\n* Prospective patients scheduled to undergo a second or multiple thoracic or lumbar spinal fusion surgery\n* Previous cardiac surgery\n* Chronic pain syndromes\n* Chronic opioid usage\n* History of psychosis\n* Prolonged bleeding\n* Intubation greater than 24 hours\n* Illicit\u002Frecreation drug use\n* Paralysis diagnosis\n* History of chronic pain requiring medical intervention\n* Neuromuscular scoliosis diagnosis\n* Cerebral palsy diagnosis\n* Developmental delay characteristics","ALL","7 Years","19 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this research is to look at the effect of massage therapy on the pain, anxiety, and quality of life that pediatric patients have after undergoing spinal fusion surgery. This is a single-site, prospective, randomized, interventional study design that will involve post-thoracic and post-lumbar spinal fusion surgeries of pediatric patients from 7 to 19 years of age that present to Cook Children's Medical Center in Fort Worth, Texas. These patients will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study. The planned spinal fusion surgeries are not considered part of this research project, but rather considered standard of care and would occur whether the patient is enrolled in this project or not. Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2, 6, and 12. Participants will be randomly assigned to either a massage therapy group or a group that receives the standard (normal) care for recovery after surgery. The final study involvement will occur at week 16 (post-hospital discharge) where a study team member will administer a quality of life (PedsQL) questionnaire via phone or mail with the subject. Data will be collected after study related procedures are completed.",[78,79,80],"Scoliosis; Adolescence","Adolescent Idiopathic Scoliosis, Thoracic Region","Adolescent Idiopathic Scoliosis, Lumbar Region",[82,21,83,84],"Spinal Fusion","Pain Management","Scoliosis","2024-05-22",{"date":87,"type":88},"2024-05-23","ACTUAL",{"date":90,"type":88},"2021-02-17",{"date":92,"type":72},"2026-08-01",{"name":5,"class":6},1]