Massage Therapy After Thoracic or Lumbar Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-19
SponsorCook Children's Health Care System

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Massage Therapy

Treatment groups

100 Participants
are divided into 2 treatment groups