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Massage Therapy for Scoliosis

N/A
Recruiting
Led By Meredith Brooks, MD
Research Sponsored by Cook Children's Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant needs to be verbal
Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery
Must not have
History of chronic pain requiring medical intervention
Prospective patients scheduled to undergo any spinal fusion other than a thoracic or lumbar spinal fusion surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op day 2, day 4/5, week 2, week 6, and week 12
Awards & highlights

Summary

This trial aims to study how massage therapy affects the pain, anxiety, and quality of life of pediatric patients after spinal fusion surgery. The study will include pediatric patients aged 7 to 19 undergoing thor

Who is the study for?
This trial is for pediatric patients aged 7 to 19 who are undergoing spinal fusion surgery at Cook Children's Medical Center in Fort Worth, Texas. They must be scheduled for standard thoracic or lumbar surgery and able to participate in follow-up visits.
What is being tested?
The study tests the impact of massage therapy on pain, anxiety, and quality of life after spinal fusion surgery compared to standard care. Participants will be randomly assigned to either receive massage therapy or the usual post-surgery care.
What are the potential side effects?
While not explicitly mentioned, potential side effects from massage therapy could include temporary discomfort, bruising, or swelling at the site of the massage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can communicate using spoken words.
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I am scheduled for my first spine fusion surgery in the chest or lower back area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chronic pain that needs medical treatment.
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I am scheduled for spinal fusion surgery that is not in my thoracic or lumbar region.
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I have been diagnosed with neuromuscular scoliosis.
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I suffer from long-term pain.
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I am scheduled for another surgery on my spine in the chest or lower back area.
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I have had heart surgery in the past.
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I have been diagnosed with paralysis.
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I have been diagnosed with cerebral palsy.
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I experience prolonged bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-op day 2, day 4/5, week 2, week 6, and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-op day 2, day 4/5, week 2, week 6, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pediatric Pain - Short Form (Neuro-QOL™)
Visual Analogue Scale (VAS) Pain Rating Scale
Wong-Baker FACES® Pain Rating Scale
Secondary outcome measures
Anxiety Thermometer
Blood pressure
Heart Rate
+4 more
Other outcome measures
Scoliosis Patient Questionnaire (SRS-30)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Massage Therapy GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 Intervention
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.

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Who is running the clinical trial?

Cook Children's Health Care SystemLead Sponsor
9 Previous Clinical Trials
5,000,759 Total Patients Enrolled
Meredith Brooks, MDPrincipal InvestigatorCook Children's Health Care System
~30 spots leftby Apr 2026
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