Clinical Trial

Massage Therapy After Thoracic or Lumbar Surgery

Unknown
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Record status
This record was last updated May 23, 2024 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT06424158
Lead Sponsor Cook Children's Health Care System
Conditions Scoliosis; Adolescence, Adolescent Idiopathic Scoliosis, Thoracic Region, Adolescent Idiopathic Scoliosis, Lumbar Region
Enrollment 100 participants
Start Date 2021-02-17
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2024-05-23