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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 immediately after surgery, daily for up to 7 days after surgery, week 2, week 6, and week 12

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after surgery, daily for up to 7 days after surgery, week 2, week 6, and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after surgery, daily for up to 7 days after surgery, week 2, week 6, and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after surgery, daily for up to 7 days after surgery, week 2, week 6, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pediatric Pain - Short Form (Neuro-QOL™)

Visual Analogue Scale (VAS) Pain Rating Scale

Wong-Baker FACES® Pain Rating Scale

Secondary study objectives

Anxiety Thermometer

Blood pressure

Heart Rate

+4 more

Other study objectives

Scoliosis Patient Questionnaire (SRS-30)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met