Bunge, E.M. (Eveline); Koning, de H.J. (Harry); Been, H.D. (Henk); Biezen, van F.C. (Frans); Gruijter, de B.J. (Bert); Jonbergen, van H.P.W.; Klerk, L.W.L. (Luuk); Kleuver, de M. (Marinus); Klop, P.H.J. (Patrick); Nies, de F. (Frank); Pruijs, H.E.H. (Hans); Teeuwen, M.P. (Marcel); Tilman, P.B.J. (Pieter)
Background. The effectiveness of bracing patients with IS has not yet been convincingly established due to a lack of RCTs. Some authors suggest that their results confirm that bracing is effective; others conclude that the effectiveness of bracing is doubtful or recommend a RCT. The aim of this study was to establish whether bracing patients with idiopathic scoliosis (IS) in an early stage will result in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow-up. Methods. A randomized controlled trial was designed. Eligible patients are girls and boys in the age group 8-15 years whose diagnosis of IS has been established by an orthopedic 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 ? 2). The Cobb angle of the eligible patient 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; established progression for the latter is not necessary. A total of 100 patients will be included in this trial. The intervention group will be treated with full-time Boston brace wear; the control group will not be braced. Every four months, each patient will have a physical and an X-ray examination. The main outcomes will be the Cobb angle two years after inclusion and health-related quality of life. Discussion. The results of this trial will be of great importance for the discussion on early treatment for scoliosis. Furthermore, the result will also be important for screening for scoliosis policies. Trial registration. Nederlands Trialregister ISRCTN36964733.