Trial on Three Treatments for Scoliosis (CONTRAIS)

Karolinska Institute

Status: Active, not recruiting

Conditions: Idiopathic Scoliosis

Treatments: Behavioral: Scoliosis specific exercises.; Other: Self-mediated physical activity.; Procedure: Hypercorrective night-time brace

Study type: Interventional

Funder types: Other

Identifiers

NCT01761305

PG-AA-2012-12-19

Details and patient eligibility

About

Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to compare the effectiveness of night time bracing, scoliosis specific exercises and physical activity prescription in adolescents with idiopathic scoliosis.

Full description

Today, bracing is used to prevent progression of idiopathic scoliosis in children.

The evidence for bracing and physical activity for treatment of idiopathic scoliosis is poor. Only one low quality study has compared bracing with physical exercise, showing no statistical differences in the reduction or progression of scoliosis curves between the groups. To draw valid conclusions about the effectiveness of postural specific physical exercise and brace therapeutic interventions compared to a self mediated activity exercise group, a randomized controlled trial research design will be used.

Preliminary data suggests that approximately 8 hours of night-time bracing with an over-corrective brace is as effective as bracing during 23 hours per day. Night-time bracing is attractive since you wear the brace a limited amount of time.

Several theories propose that during the adolescent period of skeletal growth, bone deformation may occur due to a combination of asymetrical growth plate activity, vertebral body weakness or an imbalance of muscle forces and joint flexibility. An association between low bone mineral density and idiopathic scoliosis has been reported in the literature. Adequate physical activity levels is a requirement for normal growth and development during childhood and adolescents. It is well documented that physical exercise is associated with improvements in not only muscle strength, aerobic fitness and motor development but also bone density which may help decrease the risk of osteopenic related bone deformation.

Patients included in the study will be randomized to one of three groups. Each of the three groups will receive a physical activity prescription according to World Health Organisation recommendations. One group will additionally wear a hyper-corrective night-time brace. One group will additionally perform postural scoliosis-specific exercises. Patients not wanting to be randomized to the alternative treatments in the clinical trial will receive bracing which is the current standard treatment offered.

The purpose of the study is to compare the risk of curve progression in the different groups. Curve progression is measured on x-rays. Participation in the study will last until the curve has progressed, or until cessation of skeletal growth. Participants with braces will be instructed to wear the brace 8 hours per night. Participants receiving scoliosis specific training will receive 3x90 minute physiotherapist guided sessions with an additional session provided every 6 months for the entirety of the study. All participants will be recommended to be physically active at least 60 minutes per day.

Enrollment: 135 estimated patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic scoliosis
• Skeletally immature with estimated remaining growth for at least one year.
• Not more than one year after menarche
• Primary Cobb angle between 25 and 40 degrees.
• Curve apex T7 or caudal

Exclusion criteria

• Scoliosis with a possible non-idiopathic ethiology. Patients will be excluded from the study if the pathogenesis of the scoliosis is not idiopathic, but due to a neuromuscular, neurological, congenital malformation or trauma related comorbidity.
• Previous brace or surgical treatment for scoliosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

Brace

Experimental group

Description:

Hypercorrective night-time brace worn 8 hours per night. A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions regarding physical activity will be delivered during a one hour session.

Treatment:

Procedure: Hypercorrective night-time brace

Scoliosis specific exercises.

Experimental group

Description:

Scoliosis specific exercises. The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. An additional session will be provided every 6 months for the entirety of the study. A prescription of general physical activity will be provided at a dose of 60 minutes per day.

Treatment:

Behavioral: Scoliosis specific exercises.

Self-mediated physical activity.

Active Comparator group

Description:

A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions will be delivered during a 1 hour session.

Treatment:

Other: Self-mediated physical activity.