NCT06424158 Massage Therapy After Thoracic or Lumbar Surgery
| NCT ID | NCT06424158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cook Children's Health Care System |
| Condition | Scoliosis; Adolescence |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-02-17 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-02-17 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Meredith Brooks, MD
PRINCIPAL INVESTIGATOR
Cook Children's Health Care System
Frequently Asked Questions
Who can join the NCT06424158 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 19 Years, studying Scoliosis; Adolescence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06424158 currently recruiting?
Yes, NCT06424158 is actively recruiting participants. Contact the research team at throy.campbell@cookchildrens.org for enrollment information.
Where is the NCT06424158 trial being conducted?
This trial is being conducted at Fort Worth, United States.
Who is sponsoring the NCT06424158 clinical trial?
NCT06424158 is sponsored by Cook Children's Health Care System. The principal investigator is Meredith Brooks, MD at Cook Children's Health Care System. The trial plans to enroll 100 participants.