Clinical trial NCT01761305: Trial on Three Treatments for Scoliosis
Official title: CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: Idiopathic scoliosis
Brace
Scoliosis specific exercise
Physical activity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Region Stockholm
name: The Swedish Research Council
name: University Hospital, Linkoeping
First posted: 2013-01-04
Enrollment: 135
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radiological progression of scoliosis
timeFrame: Measured every 6 months, for an expected average of three years
Secondary outcomes:
measure: Quality of life assessed with questionnaire instruments
timeFrame: Measured every 6 months, for an expected average of three years
measure: Curve severity at end of study.
timeFrame: Measured at end of study, expected at an average of three years after study inclusion
measure: Health economic evaluations; actual cost for a treatment
timeFrame: Measured at end of study, expected an average of three years after study inclusion
measure: Neuroaxial abnormalities and risk of curve progression
timeFrame: Analysed when magnetic resonance images are available and all participants has arrived to the primary endpoint of the study
measure: Curve severity comparing night time brace and full time brace
timeFrame: From brace initiation until skeletal maturity (estimated to about 3 years after inclusion), and 2, 5 and 10 years after skeletal maturity
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset / Eskilstuna hospital
city: Jönköping
country: Sweden
facility: Ryhov Hospital
city: Linköping
country: Sweden
facility: Linköping University, Linköping University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Umeå
country: Sweden
facility: Umeå University, Norrland University Hospital
city: Västerås
country: Sweden
facility: Västerås Hospital
Study officials:
affiliation: Karolinska Institutet, Karolinska University Hospital
name: Paul Gerdhem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linköping University- Sweden, Linköping and Karolinska University Hospital - Sweden
name: Allan Abbott, MPhyt, PhD
role: STUDY_DIRECTOR
References:
citation: Abbott A, Moller H, Gerdhem P. CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2013 Sep 5;14:261. doi: 10.1186/1471-2474-14-261.