RecruitingNot ApplicableNCT06424158

Massage Therapy After Thoracic or Lumbar Surgery

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


Sponsor

Cook Children's Health Care System

Enrollment

100 participants

Start Date

Feb 17, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 7 YearsMax Age: 19 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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

Interventions

OTHERMassage Therapy

Massage therapy (MT) has been proven as an alternative non-opioid pain management intervention, particularly towards reducing pain, diminishing depression, improving immune function, and increasing alertness in the adult population. MT raises the temperature of local tissues, dilates capillaries, accelerates the circulation of blood and lymph, promotes the absorption of local tissue metabolism and mass inflammation, improves the nutritional supply of surrounding muscle groups, promotes their growth and development, and relieves pain.


Locations(1)

Cook Children's Medical Center

Fort Worth, Texas, United States

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NCT06424158