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Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis A Randomized Clinical Trial [with consumer summary] |
Charalampidis A, Diarbakerli E, Dufvenberg M, Jalalpour K, Ohlin A, Ahl AA, Moller H, Abbott A, Gerdhem P |
JAMA Network Open 2024 Jan;7(1):e2352492 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
IMPORTANCE: Moderate-grade adolescent idiopathic scoliosis (AIS) may be treated with full-time bracing. For patients who reject full-time bracing, the effects of alternative, conservative interventions are unknown. OBJECTIVE: To determine whether self-mediated physical activity combined with either nighttime bracing (NB) or scoliosis-specific exercise (SSE) is superior to a control of physical activity alone (PA) in preventing Cobb angle progression in moderate-grade AIS. DESIGN, SETTING, AND PARTICIPANTS: The Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS) randomized clinical trial was conducted from January 10, 2013, through October 23, 2018, in 6 public hospitals across Sweden. Male and female children and adolescents aged 9 to 17 years with an AIS primary curve Cobb angle of 25 degrees to 40 degrees, apex T7 or caudal, and skeletal immaturity based on estimated remaining growth of at least 1 year were included in the study. Dates of analysis were from October 25, 2021, to January 28, 2023. interventions: Interventions included self-mediated physical activity in combination with either NB or SSE or PA (control). Patients with treatment failure were given the option to transition to a full-time brace until skeletal maturity. MAIN OUTCOMES AND MEASURES: The primary outcome was curve progression of 6 degrees or less (treatment success) or curve progression of more than 6 degrees (treatment failure) seen on 2 consecutive posteroanterior standing radiographs compared with the inclusion radiograph before skeletal maturity. A secondary outcome of curve progression was the number of patients undergoing surgery up until 2 years after the primary outcome. RESULTS: The CONTRAIS study included 135 patients (45 in each of the 3 groups) with a mean (SD) age of 12.7 (1.4) years; 111 (82%) were female. Treatment success was seen in 34 of 45 patients (76%) in the NB group and in 24 of 45 patients (53%) in the PA group (odds ratio (OR) 2.7; 95% CI 1.1 to 6.6). The number needed to treat to prevent curve progression with NB was 4.5 (95% CI 2.4 to 33.5). Treatment success occurred in 26 of 45 patients (58%) in the SSE group (OR for SE versus PA 1.2; 95% CI 0.5 to 2.8). Up to 2 years after the primary outcome time point, 9 patients in each of the 3 groups underwent surgery. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, treatment with NB prevented curve progression of more than 6 degrees to a significantly higher extent than did PA, while SSE did not; in addition, allowing transition to full-time bracing after treatment failure resulted in similar surgical frequencies independent of initial treatment. These results suggest that NB may be an effective alternative intervention in patients rejecting full-time bracing. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01761305.
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