Dataset Information

Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

ABSTRACT:

Study design

Descriptive.

Objective

To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

Summary of background data

Bracing has remained the standard of care for the nonoperative treatment of adolescent idiopathic scoliosis since the introduction of the Milwaukee brace in the late 1940s, but it has never been subjected to a rigorous evaluation of either its efficacy or its effectiveness. The BrAIST was designed to address the primary question: Do braces (specifically a thoracolumbosacral orthosis) lower the risk of curve progression to a surgical threshold (≥50°) in patients with adolescent idiopathic scoliosis relative to watchful waiting alone?

Methods

The authors describe the rationale for BrAIST, including the limitations of the current literature evaluating bracing for adolescent idiopathic scoliosis. Second, the authors describe the preliminary work, including the preparation of the National Institutes of Health clinical trials planning grant. Finally, the authors describe the trial design in detail.

Results

BrAIST was conducted in 25 sites in North America. Subjects were treated either with a thoracolumbosacral orthosis or watchful waiting and followed every 6 months until they reached skeletal maturity or the surgical threshold of 50° Cobb angle.

Conclusion

Clinical decision making will be improved by translation of the BrAIST results into evidence-based prognosis and estimates of how the prognosis, specifically the risk of progressing to surgery, may be altered by the use of bracing.

Level of evidence

N/A.

SUBMITTER: Weinstein SL

PROVIDER: S-EPMC4536980 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

Weinstein Stuart L SL Dolan Lori A LA Wright James G JG Dobbs Matthew B MB

Spine 20131001 21

<h4>Study design</h4>Descriptive.<h4>Objective</h4>To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).<h4>Summary of background data</h4>Bracing has remained the standard of care for the nonoperative treatment of adolescent idiopathic scoliosis since the introduction of the Milwaukee brace in the late 1940s, but it has never been subjected to a rigorous evaluation of either its efficacy or its effectiveness. The BrAIST was designed to address the ...[more]

PMID: 24026162

Similar Datasets

Project description:ImportanceModerate-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.ObjectiveTo 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 participantsThe 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.InterventionsInterventions 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 measuresThe 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.ResultsThe 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 relevanceIn 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.Trial registrationClinicalTrials.gov Identifier: NCT01761305.

Project description:Study designProspective multicenter study data were used for model derivation and externally validated using retrospective cohort data.ObjectiveDerive and validate a prognostic model of benefit from bracing for adolescent idiopathic scoliosis (AIS).Summary of background dataThe Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) demonstrated the superiority of bracing over observation to prevent curve progression to the surgical threshold; 42% of untreated subjects had a good outcome, and 28% progressed to the surgical threshold despite bracing, likely due to poor adherence. To avoid over-treatment and to promote patient goal setting and adherence, bracing decisions (who and how much) should be based on physician and patient discussions informed by individual-level data from high-quality predictive models.Materials and methodsLogistic regression was used to predict curve progression to <45° at skeletal maturity (good prognosis) in 269 BrAIST subjects who were observed or braced. Predictors included age, sex, body mass index, Risser stage, Cobb angle, curve pattern, and treatment characteristics (hours of brace wear and in-brace correction). Internal and external validity were evaluated using jackknifed samples of the BrAIST data set and an independent cohort (n=299) through estimates of discrimination and calibration.ResultsThe final model included age, sex, body mass index, Risser stage, Cobb angle, and hours of brace wear per day. The model demonstrated strong discrimination ( c -statistics 0.83-0.87) and calibration in all data sets. Classifying patients as low risk (high probability of a good prognosis) at the probability cut point of 70% resulted in a specificity of 92% and a positive predictive value of 89%.ConclusionThis externally validated model can be used by clinicians and families to make informed, individualized decisions about when and how much to brace to avoid progression to surgery. If widely adopted, this model could decrease overbracing of AIS, improve adherence, and, most importantly, decrease the likelihood of spinal fusion in this population.

Project description:ObjectiveTo analyze the correlation between the polymorphism on interleukin 6 (IL-6) gene promoter region-174 locus and adolescent idiopathic scoliosis (AIS), including the susceptibility, the bracing effectiveness, and the possible mechanism.MethodsThe 182 AIS patients and 210 healthy controls who met the inclusion criteria between January 2013 and January 2016 were collected as research objects. The genotype of IL-6 gene promoter region-174 locus, the serum IL-6, the bone mineral density (BMD) of femoral neck and vertebrae (L 1-4), and the bone metabolism parameters, including bone alkaline phosphatase (BALP), bone gla protein (BGP), tartrate resistant acid phosphatase 5b (TRACP-5b), urine Ca, and urine Ca/Cr, were detected. All research objects were divided into the AIS group and the control group according to whether they had AIS, the GG, CG, CC groups according to their genotype, and progression-free group and progression group according to the therapeutic effectiveness of 1-year bracing treatment. Statistical analysis for the indexes were conducted respectively.ResultsThere were significant differences in AIS history, BMD of femoral neck and lumbar vertebrae between the AIS group and control group ( P<0.05). According to the therapeutic effecitveness of 1-year bracing treatment, 182 AIS patients were divided into progression-free group in 110 cases and progression group in 72 cases. The results of single factor analysis showed that there were significant differences in the genotype and allele distribution of IL-6 gene promoter region-174 locus, BMD of femoral neck and lumbar vertebrae, IL-6, TRACP-5b, urine Ca, and urine Ca/Cr between the progression-free group and progression group ( P<0.05). The results of multivariable analysis showed that the BMD of lumbar vertebrae, TRACP-5b, and urine Ca were the influencing factors of bracing efficacy ( P<0.05). According to the results of genotype detection, all research objects were divided into GG group in 264 cases, CG group in 104 cases, and CC group in 24 cases. The IL-6, TRACP-5b, urine Ca, and urine Ca/Cr of GG type carriers were higher and BMD of femoral neck and lumbar vertebrae were lower when compared with the CG and CC type carriers ( P<0.05). The BMD of lumbar vertebrae of CG type carriers was lower than that of CC type carriers ( P<0.05).ConclusionThe polymorphism of IL-6 genepromoter region-174 locus wasn't correlated with the AIS susceptibility, but it was correlated (not independently correlated) with the scoliosis progression under bracing treatment, and the risk for G-carried patients was higher. The mechanism may be that the polymorphism affected the IL-6 expression level and eventually affected the BMD of AIS patients through the bone metabolism.

Project description:This review aimed to systematically review and meta-analyze the effects of interventions in improving bracing compliance among adolescent idiopathic scoliosis (AIS) patients. Eight databases were searched from their inception to April 2022. The eligibility criteria included controlled studies that used any type of intervention to enhance bracing compliance in braced AIS patients. Two researchers independently screened articles and extracted data based on the PICO (participant, intervention, comparator, and outcome) framework. Quality appraisal of included studies was performed using GRADE (overall assessment), and the risk of bias was assessed with Cochrane RoB Tool 2 for randomized controlled trials (RCT) and ROBINS-I for non-RCT studies. The primary outcome was bracing compliance and secondary outcomes included Cobb Angle and measurements for quality of life. Six eligible studies involving 523 participants were included. All studies were evaluated as low or very low quality with a high risk of bias. Four types of interventions were identified, including sensor monitoring (n = 2, RCTs), auto-adjusted brace (n = 1, RCT), more intensive or collaborated medical care (n = 2), and psychosocial intervention (n = 1). A meta-analysis of 215 patients from the three RCTs suggested that the compliance-enhancing intervention group had 2.92 more bracing hours per day than the usual care control (95%CI [1.12, 4.72], P = 0.001). In subgroup analysis, sensor monitoring significantly improved bracing wearing quantity compared to usual care (3.47 hours/day, 95%CI [1.48, 5.47], P = 0.001), while other aforementioned interventions did not show a significant superiority. Compliance-enhancing interventions may be favorable in preventing curve progression and promoting quality of life, but the improvements cannot be clarified according to limited evidence. In conclusion, although the results of this study suggested that sensor monitoring may be the most promising approach, limited high-quality evidence precludes reliable conclusions. Future well-designed RCTs are required to confirm the actual benefit of compliance-improving interventions in clinical practice.

Project description:ImportanceThe effectiveness of a training support program of individually tailored physiotherapeutic scoliosis-specific exercises (PSSEs) delivered via a digital care system is unclear.ObjectiveTo determine the effectiveness of a digital care program in which patients receive PSSE supervision and guidance via the Healbone Intelligent Rehabilitation System and educational videos compared with a conventional intervention involving 3 treatment sessions conducted by qualified physiotherapists at outpatient clinics or specialized orthopedic institutions and unsupervised home-based PSSE training.Design, setting, and participantsThis randomized clinical trial recruited patients aged 9 to 17 years from Peking Union Medical College Hospital in Beijing, China, who had adolescent idiopathic scoliosis with a primary curve Cobb angle of 10° or greater and skeletal immaturity (as determined via the Risser grading system). The trial was conducted from June 1, 2023, to August 10, 2024.InterventionsPatients were randomly assigned to a digital care (DC) group, in which each patient received fully remote and home-based PSSE training supported by a digital care system, or a usual care group, in which each patient completed 3 treatment sessions conducted by qualified physiotherapists at outpatient clinics or specialized orthopedic institutions and home-based PSSE training without supervision.Main outcomes and measuresThe primary outcome was a change in the Cobb angle of the major curve between baseline and month 6 of the intervention. Primary and secondary outcomes were evaluated using an independent samples t test. The proportion of patients who exhibited disease progression or improvement in the Cobb angle between the 2 groups was compared using a χ2 test.ResultsOf 591 patients assessed for eligibility, 436 did not meet the eligibility criteria, 12 declined to participate, and 15 withdrew before randomization. The remaining 128 patients were randomized to 2 parallel groups, with 64 patients in each group (mean [SD] age, 11.1 (2.2) years; 97 female [75.8%]), all of whom completed the baseline assessment and 6-month follow-up. The mean difference in the improvement of the Cobb angle between the DC group and the usual care group after a 6-month intervention was -4.23° (95% CI, -6.08° to -2.39°) in the intention-to-treat analysis and -4.01° (95% CI, -5.68° to -2.35°) in the per-protocol analysis. The posttreatment Cobb angle was adjusted by using analysis of covariance, and the mean of the difference in the adjusted posttreatment Cobb angle between 2 groups was -4.24° (95% CI, -6.09° to -2.38°).Conclusions and relevanceIn this randomized clinical trial, the effectiveness of individually tailored PSSE training support delivered via a digital care system was superior to that of a conventional PSSE training model in improving the Cobb angle. This mode of exercise may be an effective and convenient alternative for individuals with adolescent idiopathic scoliosis.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR2300076563.

Dataset Information

Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

Study design

Objective

Summary of background data

Methods

Results

Conclusion

Level of evidence

Publications

Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

Similar Datasets

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