Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis A Randomized Clinical Trial
(2024) In JAMA Network Open 7(1).- Abstract
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... (More)
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° to 40°, 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° or less (treatment success) or curve progression of more than 6° (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, 1.1-6.6). The number needed to treat to prevent curve progression with NB was 4.5 (95% CI, 2.4-33.5). Treatment success occurred in 26 of 45 patients (58%) in the SSE group (OR for SE vs PA, 1.2; 95% CI, 0.5-2.8). 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° 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.
(Less)
- author
- Charalampidis, Anastasios ; Diarbakerli, Elias ; Dufvenberg, Marlene ; Jalalpour, Kourosh ; Ohlin, Acke LU ; Ahl, Anna Aspberg ; Möller, Hans ; Abbott, Allan and Gerdhem, Paul
- author collaboration
- organization
- publishing date
- 2024-01
- type
- Contribution to journal
- publication status
- published
- subject
- in
- JAMA Network Open
- volume
- 7
- issue
- 1
- article number
- E2352492
- publisher
- American Medical Association
- external identifiers
-
- scopus:85183754812
- pmid:38285447
- ISSN
- 2574-3805
- DOI
- 10.1001/jamanetworkopen.2023.52492
- language
- English
- LU publication?
- yes
- id
- 9a01dfc9-e444-4c0c-8156-b1826c2cd514
- date added to LUP
- 2024-03-08 13:54:57
- date last changed
- 2024-06-29 13:52:10
@article{9a01dfc9-e444-4c0c-8156-b1826c2cd514, abstract = {{<p>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° to 40°, 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° or less (treatment success) or curve progression of more than 6° (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, 1.1-6.6). The number needed to treat to prevent curve progression with NB was 4.5 (95% CI, 2.4-33.5). Treatment success occurred in 26 of 45 patients (58%) in the SSE group (OR for SE vs PA, 1.2; 95% CI, 0.5-2.8). 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° 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.</p>}}, author = {{Charalampidis, Anastasios and Diarbakerli, Elias and Dufvenberg, Marlene and Jalalpour, Kourosh and Ohlin, Acke and Ahl, Anna Aspberg and Möller, Hans and Abbott, Allan and Gerdhem, Paul}}, issn = {{2574-3805}}, language = {{eng}}, number = {{1}}, publisher = {{American Medical Association}}, series = {{JAMA Network Open}}, title = {{Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis A Randomized Clinical Trial}}, url = {{http://dx.doi.org/10.1001/jamanetworkopen.2023.52492}}, doi = {{10.1001/jamanetworkopen.2023.52492}}, volume = {{7}}, year = {{2024}}, }