Trial on Three Treatments for Scoliosis
Trial on Three Treatments for Scoliosis
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.
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.
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.