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Effectiveness of bracing patients with adolescent idiopathic scoliosis.


- candidate number1932
- NTR NumberNTR563
- ISRCTNISRCTN36964733
- Date ISRCTN created14-feb-2006
- date ISRCTN requested27-jan-2006
- Date Registered NTR17-jan-2006
- Secondary IDsZonMw projectnumber: 945-06-354 
- Public TitleEffectiveness of bracing patients with adolescent idiopathic scoliosis.
- Scientific TitleEffectiveness of bracing patients with adolescent idiopathic scoliosis.
- ACRONYMN/A
- hypothesisBracing 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.
- Healt Condition(s) or Problem(s) studiedAdolescent idiopathic scoliosis (AIS)
- Inclusion criteriaEligible patients are girls and boys in the age group 8-15 years whose diagnosis of AIS has been established by an orthopaedic surgeon, who have not yet been treated by bracing or surgery and for whom further growth of physical height is still expected based on medical examination and maturation characteristics (Risser sign) established by X-ray. To expect further growth of physical height, patients only with Risser sign < 3 will be included. As agreed in the consensus by de different health professionals in the orthopaedic field, the Cobb angle should either be minimally 22 and maximally 29 degrees with established progression of more than 5 degrees or should be minimally 30 and maximally 35 degrees; progression for the latter is not necessarily established.
- Exclusion criteriaPatients with other forms of scoliosis (e.g. as a result of neuromuscular diseases) are excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 19-jan-2006
- planned closingdate31-mrt-2009
- Target number of participants100
- InterventionsPatients 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.
- Primary outcomeCobb angle, two years after inclusion.
- Secondary outcomeQuality of life, patient preferences, costs.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. E.M. Bunge
- CONTACT for SCIENTIFIC QUERIESDr. MD. H.J. Koning, de
- Sponsor/Initiator Erasmus Medical Center, Department of Public Health
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Vereniging Trustfonds Erasmus University Rotterdam, Stichting Nuts Ohra
- PublicationsN/A
- Brief summaryEach 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.
- Main changes (audit trail)
- RECORD17-jan-2006 - 6-mrt-2006


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