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

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding massage therapy to the recovery process after thoracic or lumbar spinal fusion surgery helps reduce pain, improve recovery, and decrease reliance on opioid pain medications. **You may be eligible if...** - You are scheduled to have your first thoracic (mid-back) or lumbar (lower back) spinal fusion surgery - You are able to participate in massage therapy as part of your recovery - You can communicate verbally and understand the study requirements **You may NOT be eligible if...** - You have had previous spinal fusion surgery of the same type - You have had prior heart surgery - You have chronic pain conditions or are a regular opioid user - You have a history of psychosis, paralysis, cerebral palsy, or developmental delay - You are expected to need a breathing machine (ventilator) for more than 24 hours after surgery - You use illicit drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


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