Actively Recruiting

Phase Not Applicable
Age: 7Years - 19Years
All Genders
NCT06424158

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

Age: 7Years - 19Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

Actively Recruiting

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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

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