Physical Activity Monitoring for Scoliosis
(SAMUS SCOLI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and potential ways to mitigate the potential harms of treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is physical activity monitoring for scoliosis safe for humans?
The research indicates that both bracing and spinal fusion surgery for scoliosis are generally safe, with no significant differences in function, pain, self-image, and mental health reported. However, bracing may lead to reduced physical activity, so patients should be encouraged to maintain recommended activity levels.12345
How does spinal fusion surgery differ from other treatments for scoliosis?
Spinal fusion surgery for scoliosis is unique because it involves permanently connecting two or more vertebrae in the spine to correct curvature, unlike bracing which is non-surgical and aims to prevent further curvature. This surgery can improve physical activity levels over time, as shown by increased steps and distance walked post-surgery, whereas bracing may lead to reduced physical activity.13678
What data supports the effectiveness of the treatment for scoliosis?
Who Is on the Research Team?
Todd Milbrandt, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for boys and girls aged 9-16 with severe scoliosis needing spinal fusion surgery or brace treatment. A control group of similar age, gender, and BMI with healed forearm fractures will also participate to compare muscle function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Physical activity and paraspinal muscle stiffness are measured using Tri-axial accelerometers and Shear Wave Elastography before treatment
Treatment
Participants undergo bracing or spinal fusion surgery for scoliosis treatment
Follow-up Assessment
Physical activity and paraspinal muscle stiffness are re-evaluated using Tri-axial accelerometers and Shear Wave Elastography one year after treatment
Follow-up
Participants are monitored for changes in physical activity and muscle function after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bracing
- Shear Wave Elastography (SWUE)
- Spinal Fusion Surgery
- Tri-axial Accelerometers
Spinal Fusion Surgery is already approved in United States, European Union for the following indications:
- Osteoporosis in postmenopausal women at high risk of fracture
- Increase bone density in men with osteoporosis
- Osteoporosis in postmenopausal women at increased risk of fracture
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor