Trial on Three Treatments for Scoliosis (CONTRAIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01761305|
Recruitment Status : Recruiting
First Posted : January 4, 2013
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment|
|Idiopathic Scoliosis||Procedure: Hypercorrective night-time brace Behavioral: Scoliosis specific exercises. Other: Self-mediated physical activity.|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis. A Randomised Controlled Trial|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||December 2021|
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.
Procedure: Hypercorrective night-time brace
Hypercorrective night-time brace worn 8 hours per night. Patients are encouraged to also continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
Experimental: Scoliosis specific exercises.
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.
Behavioral: Scoliosis specific exercises.
The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. Goals are directed towards active self-correction and postural control, spinal stability, aerobic functioning and development of a positive body image. Additional postural specific exercises including self-mediated hyper-corrective exercises are to be performed with moderate intensity at least for 30 minutes at least 2-3 times per week. Other physical activities to fulfill the general recommended quota of more than 60 minutes moderate intensity physical activity per day are recommended. Reinforcement of the intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
Active Comparator: Self-mediated physical activity.
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.
Other: Self-mediated physical activity.
Instructions for self-mediated physical activity will be delivered during a 1 hour session. Patients are encouraged to perform self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
- Radiological progression of scoliosis [ Time Frame: Measured every 6 months, for an expected average of three years ]Progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays.
- Quality of life [ Time Frame: Measured every 6 months, for an expected average of three years ]Quality of life measured with validated questionnaires such as Euroqol (EQ5D-Y), Scoliosis Research Society outcomes questionnaire 22r (SRS22r), International Physical Activity Questionnaire (IPAQ) and the Walter Reed Visual Assessment Scale.
- Curve severity at end of study. [ Time Frame: Measured at end of study, expected at an average of three years after study inclusion ]Curve severity measured as Cobb angle at end of study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761305
|Contact: Paul Gerdhem, MD, PhDfirstname.lastname@example.org|
|Contact: Allan Abbott, MPhyt, PhDemail@example.com|
|Mälarsjukhuset / Eskilstuna hospital||Recruiting|
|Eskilstuna, Sweden, 63188|
|Contact: Ylva Bodén, MD|
|Contact: Ingrid Ekenman, MD, PhD|
|Jönköping, Sweden, 55185|
|Contact: Anna Aspberg Ahl, MD|
|Linköping University, Linköping University Hospital||Recruiting|
|Linköping, Sweden, 58183|
|Contact: Allan Abbott, PhD +46733816914 firstname.lastname@example.org|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 14186|
|Principal Investigator: Paul Gerdhem, MD, PhD|
|Principal Investigator: Allan Abbott, MPhyt, PhD|
|Sub-Investigator: Hans Möller, MD, PhD|
|Sundsvall, Sweden, 85186|
|Contact: Anna Grauers, MD|
|Umeå University, Norrland University Hospital||Recruiting|
|Umeå, Sweden, 90185|
|Contact: Pawel Grabowski, MD, PhD|
|Västerås, Sweden, 72189|
|Contact: Björn Dahlman, MD|
|Principal Investigator:||Paul Gerdhem, MD, PhD||Karolinska Institutet, Karolinska University Hospital|
|Study Director:||Allan Abbott, MPhyt, PhD||Linköping University- Sweden, Linköping and Karolinska University Hospital - Sweden|