Actively Recruiting
Massage Therapy After Thoracic or Lumbar Surgery
Led by Cook Children's Health Care System · Updated on 2024-05-23
100
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Massage Therapy After Thoracic or Lumbar Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery
- Able to participate and perform in massage therapy as a recovery option
- Participant needs to be verbal
- Ability to understand study procedures and comply with them for the entire study duration
You will not qualify if you...
- Scheduled for any spinal fusion surgery other than thoracic or lumbar spinal fusion
- Scheduled for a second or multiple thoracic or lumbar spinal fusion surgeries
- Previous cardiac surgery
- Chronic pain syndromes
- Chronic opioid usage
- History of psychosis
- Prolonged bleeding
- Intubation longer than 24 hours
- Illicit or recreational drug use
- Paralysis diagnosis
- History of chronic pain requiring medical intervention
- Neuromuscular scoliosis diagnosis
- Cerebral palsy diagnosis
- Developmental delay characteristics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
Research Team
T
Throy Campbell, PhD
CONTACT
K
Kristy Reyes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here