Effectiveness of bracing patients with adolescent idiopathic scoliosis.

Each year around 300-400 adolescents are being diagnosed with progressive Adolescent Idiopathic Scoliosis (AIS, a lateral curvature of the spine), of whom half are detected by the nationwide screening programme for scoliosis at schools. AIS may lead to serious cosmetic and psychosocial problems, spine degeneration and severe forms may cause intrathoracal problems. The common early treatment for AIS is bracing, a close-fitting brace being applied to the trunk. The ultimate goal of bracing is prevention of progression and thereby surgery, which may have serious complications. A brace should be worn for 18-23 hours a day and for many years during adolescence; 70% of patients regard this treatment as (very) unpleasant. However, the effectiveness of early AIS treatment by bracing has never been demonstrated in randomised controlled trials (RCT). In practice, there is no evidence that bracing AIS patients is better than active surveillance, awaiting further progression in some patients.

In this individual RCT, 100 consecutive AIS patients with Cobb angles of 22-35 degrees will be randomised either to the intervention group, who will get brace treatment, or to the control group, who is offered regular surveillance only. At 4 months follow-up examinations, two orthopaedic surgeons will measure Cobb angles in both groups blindly and independently. Bracing will be considered effective if after 2 years of follow-up the progression of the curvature in the intervention group is at least 5 degrees less (clinically relevant), on average, compared to the control group.

Bracing patients with adolescent idiopathic scoliosis in an early stage results in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow up.

Patients in the intervention group will be treated with a brace. The brace is a device that fits closely around the body to exert pressure to the trunk in order to push the spine into a straighter position. The patients will be advised to wear the brace every day for 18-23 hours. Patients are allowed to go to physiotherapy if they want to, but this is not obligatory. Patients of the control group will initially not be braced during the two study years, unless their curvature shows more than 10 degrees progression compared to the Cobb angle at inclusion. The patients of the control group are allowed to go to physical therapy, because physical therapy alone will not prevent further progression of the curvature.The orthopaedic surgeons willexamine all patients every four months, amongst other things by X-ray.