Massage Therapy After Thoracic or Lumbar Surgery

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Cook Children's Health Care System
Study ID
NCT06424158
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
7 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Massage Therapy — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 17, 2021
Status verified
May 2024
Primary completion
Apr 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Massage Therapy Group
    Participants in the massage therapy group are treated by a certified pediatric massage therapist for at least two 30- minute massage therapy sessions performed on postoperative days two and four or five. Participants will continue to receive standard of care, including any pain medications as needed.
  • No Intervention: Control Group
    Participants in control group will continue to receive the normal standard of care as usual for their recovery and will be monitored by hospital staff in obtaining the same data points recorded clinically for post-op days 2 and 4/5; however, no therapeutic intervention will occur.

Primary Outcome Measure

Pediatric Pain - Short Form (Neuro-QOL™) [ Time Frame: Post-op day 2, day 4/5, week 2, week 6, and week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cook Children's Medical CenterFort WorthTexas76104
Laurie Bailey, PhD
[email protected]
682-885-2488
Meredith Brooks, MD (PRINCIPAL_INVESTIGATOR)

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Cook Children's Medical Center· Fort Worth, TX

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