Massage Therapy After Thoracic or Lumbar Surgery
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.
Conditions:
🦠 Scoliosis; Adolescence 🦠 Adolescent Idiopathic Scoliosis, Thoracic Region 🦠 Adolescent Idiopathic Scoliosis, Lumbar Region
🗓️ Study Start (Actual) 17 February 2021
🗓️ Primary Completion (Estimated) 1 April 2026
✅ Study Completion (Estimated) 1 August 2026
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Fort Worth, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery
    • * Able to participate and perform in a massage therapy as a recovery option
    • * Participant needs to be verbal
    • * Ability to understand study procedures and to comply with them for the entire length of the study

    Exclusion Criteria:

    • * Prospective patients scheduled to undergo any spinal fusion other than a thoracic or lumbar spinal fusion surgery.
    • * Prospective patients scheduled to undergo a second or multiple thoracic or lumbar spinal fusion surgery
    • * Previous cardiac surgery
    • * Chronic pain syndromes
    • * Chronic opioid usage
    • * History of psychosis
    • * Prolonged bleeding
    • * Intubation greater than 24 hours
    • * Illicit/recreation drug use
    • * Paralysis diagnosis
    • * History of chronic pain requiring medical intervention
    • * Neuromuscular scoliosis diagnosis
    • * Cerebral palsy diagnosis
    • * Developmental delay characteristics
Ages Eligible for Study: 7 Years to 19 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 April 2024
  • First Submitted that Met QC Criteria 20 May 2024
  • First Posted 22 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 May 2024
  • Last Update Posted 23 May 2024
  • Last Verified May 2024