RECRUITING

Massage Therapy After Thoracic or Lumbar Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Impact of Massage Therapy on Post-Surgical Pain, Anxiety, Quality of Life, and Opioid Analgesia Exposure on Children After Thoracic or Lumbar Surgery

Quick Facts

Study Start:2021-02-17
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06424158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery
  2. * Able to participate and perform in a massage therapy as a recovery option
  3. * Participant needs to be verbal
  4. * Ability to understand study procedures and to comply with them for the entire length of the study
  1. * Prospective patients scheduled to undergo any spinal fusion other than a thoracic or lumbar spinal fusion surgery.
  2. * Prospective patients scheduled to undergo a second or multiple thoracic or lumbar spinal fusion surgery
  3. * Previous cardiac surgery
  4. * Chronic pain syndromes
  5. * Chronic opioid usage
  6. * History of psychosis
  7. * Prolonged bleeding
  8. * Intubation greater than 24 hours
  9. * Illicit/recreation drug use
  10. * Paralysis diagnosis
  11. * History of chronic pain requiring medical intervention
  12. * Neuromuscular scoliosis diagnosis
  13. * Cerebral palsy diagnosis
  14. * Developmental delay characteristics

Contacts and Locations

Study Contact

Throy Campbell, PhD
CONTACT
682-885-1044
throy.campbell@cookchildrens.org
Kristy Reyes
CONTACT
682-885-1044
kristy.reyes@cookchildrens.org

Principal Investigator

Meredith Brooks, MD
PRINCIPAL_INVESTIGATOR
Cook Children's Health Care System

Study Locations (Sites)

Cook Children's Medical Center
Fort Worth, Texas, 76104
United States

Collaborators and Investigators

Sponsor: Cook Children's Health Care System

  • Meredith Brooks, MD, PRINCIPAL_INVESTIGATOR, Cook Children's Health Care System

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

Study Start Date2021-02-17
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2021-02-17
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • Spinal Fusion
  • Massage Therapy
  • Pain Management
  • Scoliosis

Additional Relevant MeSH Terms

  • Scoliosis; Adolescence
  • Adolescent Idiopathic Scoliosis, Thoracic Region
  • Adolescent Idiopathic Scoliosis, Lumbar Region