Trial on Three Treatments for Scoliosis

Not Applicable

Active, not recruiting

• Conditions: Idiopathic Scoliosis
• Interventions: Behavioral: Scoliosis specific exercises.; Procedure: Hypercorrective night-time brace; Other: Self-mediated physical activity.

• Registration Number: NCT01761305
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study First Submitted: 2012-12-28
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2021-08-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scoliosis specific exercises.	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.
Brace	Hypercorrective night-time brace	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.
Self-mediated physical activity.	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.

Primary Outcome Measures

Name	Time	Method
Radiological progression of scoliosis	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed with questionnaire instruments	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.	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.
Curve severity comparing night time brace and full time brace	From brace initiation until skeletal maturity (estimated to about 3 years after inclusion), and 2, 5 and 10 years after skeletal maturity	Curve severity measured as Cobb angle after randomization to night time brace, or after refraining randomization and receiving a full time brace
Health economic evaluations; actual cost for a treatment	Measured at end of study, expected an average of three years after study inclusion	Actual analysis of direct costs, and estimations of indirect costs.
Neuroaxial abnormalities and risk of curve progression	Analysed when magnetic resonance images are available and all participants has arrived to the primary endpoint of the study	Analysis of prevalence of neuroaxial abnormalities and any risk of scoliosis curve progression

Trial Locations

Locations (7)

Västerås Hospital; 🇸🇪 Västerås, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden

Umeå University, Norrland University Hospital; 🇸🇪 Umeå, Sweden

Ryhov Hospital; 🇸🇪 Jönköping, Sweden

Mälarsjukhuset / Eskilstuna hospital; 🇸🇪 Eskilstuna, Sweden

Linköping University, Linköping University Hospital; 🇸🇪 Linköping, Sweden