Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis (SAMUS SCOLI)

Mayo Clinic

Status: Invitation-only

Conditions: Scoliosis

Treatments: Device: Tri-axial Accelerometers; Other: Shear Wave Elastography (SWUE); Procedure: Spinal Fusion Surgery; Other: Bracing

Study type: Interventional

Funder types: Other

Identifiers

NCT02610855

15-005602

Details and patient eligibility

About

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.

Full description

The aims include first, to quantify the posture and physical activity of patients in the community before and after scoliosis treatment and compare to age-matched controls. Patients undergoing bracing or surgery for scoliosis will wear novel low-profile electronic monitors for 4 days prior to and at one year after initiation of treatment. Accelerometer data from the 4 activity monitors are combined for a comprehensive profile of daily activity, above and beyond that of a typical pedometer. Analysis will show a participant's % active time vs. static, % time sitting vs. lying down vs. standing vs. walking, total number of steps taken per day, and cadence of walking during each activity bout. The amount of total daily time spent lying, sitting, standing, walking and running will be quantified using specialized processing algorithms developed at Mayo Clinic. Results will be compared to a group of age- and BMI-matched control patients with healed forearm fractures.

Second, to determine changes in the mechanical properties of the paraspinal skeletal musculature (muscles along the spine) in scoliosis patient before and after treatment with brace or spinal surgery.

Shear Wave Elastography (SWUE) is a technique that uses ultrasound, a non-invasive imaging technique, to detect mechanical properties of tissues. Using SWUE, the stiffness in the paraspinal muscles will be obtained by acquiring Shear modulus measurements, reported in kilo Pascal (kPa) units. 10 measurements will be obtained for each muscle and a region of interest (ROI) will be placed in the displayed elastogram or color map from each measurement to obtain a "kPa" value. A mean shear modulus or stiffness will be obtained by averaging all 10 results. The measurements from each ROI are derived using software built in the ultrasound equipment.

The change in paraspinal skeletal muscle stiffness will be assessed and compared to normal controls to determine characteristics of spinal musculature in scoliosis patients and the impact of treatment with bracing or surgery.

Enrollment: 200 estimated patients

Sex: All

Ages: 9 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females between 9 to16 years of age
• Scoliosis/Surgery group; has severe scoliosis curves requiring posterior spinal fusion surgery
• Scoliosis/Brace group; has scoliosis curves requiring brace treatment for at least the next year
• The Control group will be aged matched participants who have healed forearm fractures and will be matched to case patients by age, gender, and Body Mass Index (BMI). These children will be considered normal subjects for both the accelerometers and the Shear Wave Elastography (SWUE)

Exclusion criteria

• Patients with underlying muscle conditions or neuromuscular scoliosis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Spinal Fusion Surgery

Active Comparator group

Description:

The surgical participants recruited from the pediatric orthopaedic clinic and have severe scoliosis curves requiring posterior spinal fusion. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before and one year after spinal fusion surgery.

Treatment:

Procedure: Spinal Fusion Surgery

Other: Shear Wave Elastography (SWUE)

Device: Tri-axial Accelerometers

Brace Treatment

Active Comparator group

Description:

The bracing participants have scoliosis curves that require treatment with a spinal brace for at least the next year. All braces will have monitors to record hours of brace wear, as is current standard of care. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before bracing and after one year.

Treatment:

Other: Bracing

Other: Shear Wave Elastography (SWUE)

Device: Tri-axial Accelerometers

Control Arm

Other group

Description:

The control group are participants who do not have scoliosis. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified at baseline and one year after enrollment.

Treatment:

Other: Shear Wave Elastography (SWUE)

Device: Tri-axial Accelerometers