Clinical trial NCT02610855: Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis
Official title: Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis (SAMUS SCOLI)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Scoliosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in percentage of day with static activity
timeFrame: Baseline, 1 year
measure: Change in dynamic physical activity as measured by step counts
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Change in mean paraspinal muscle stiffness
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Todd Milbrandt, MD
role: PRINCIPAL_INVESTIGATOR
References: