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Effects of bracing in adolescents with idiopathic scoliosis.

ABSTRACT: The role of bracing in patients with adolescent idiopathic scoliosis who are at risk for curve progression and eventual surgery is controversial.We conducted a multicenter study that included patients with typical indications for bracing due to their age, skeletal immaturity, and degree of scoliosis. Both a randomized cohort and a preference cohort were enrolled. Of 242 patients included in the analysis, 116 were randomly assigned to bracing or observation, and 126 chose between bracing and observation. Patients in the bracing group were instructed to wear the brace at least 18 hours per day. The primary outcomes were curve progression to 50 degrees or more (treatment failure) and skeletal maturity without this degree of curve progression (treatment success).The trial was stopped early owing to the efficacy of bracing. In an analysis that included both the randomized and preference cohorts, the rate of treatment success was 72% after bracing, as compared with 48% after observation (propensity-score-adjusted odds ratio for treatment success, 1.93; 95% confidence interval [CI], 1.08 to 3.46). In the intention-to-treat analysis, the rate of treatment success was 75% among patients randomly assigned to bracing, as compared with 42% among those randomly assigned to observation (odds ratio, 4.11; 95% CI, 1.85 to 9.16). There was a significant positive association between hours of brace wear and rate of treatment success (P<0.001).Bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis. The benefit increased with longer hours of brace wear. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and others; BRAIST ClinicalTrials.gov number, NCT00448448.).

SUBMITTER: Weinstein SL

PROVIDER: S-EPMC3913566 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Effects of bracing in adolescents with idiopathic scoliosis.

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

The New England journal of medicine 20130919 16

<h4>Background</h4>The role of bracing in patients with adolescent idiopathic scoliosis who are at risk for curve progression and eventual surgery is controversial.<h4>Methods</h4>We conducted a multicenter study that included patients with typical indications for bracing due to their age, skeletal immaturity, and degree of scoliosis. Both a randomized cohort and a preference cohort were enrolled. Of 242 patients included in the analysis, 116 were randomly assigned to bracing or observation, and ...[more]

PMID: 24047455

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Project description:STUDY DESIGN: Systematic review. OBJECTIVES: (1) Does brace treatment compared with observation of curves lead to lower rates of surgery and failure for patients with idiopathic scoliosis? (2) Does brace treatment compared with observation of curves lead to better quality of life outcomes for patients with idiopathic scoliosis? (3) Does brace treatment compared with observation of curves lead to improved curve angle for patients with idiopathic scoliosis? METHODS: A systematic review of the English-language literature was undertaken for articles published between 1970 and December 2010. Electronic databases and reference lists of key articles were searched to identify studies comparing brace treatment with observation of curves in patients with idiopathic scoliosis. Two independent reviewers assessed the strength of evidence using the GRADE criteria assessing quality, quantity, and consistency of results. Disagreements were resolved by consensus. RESULTS: We identified eight studies meeting our inclusion criteria. The pooled studies comparing surgical rates between observation and brace treatment showed no statistical significance (P = .65). One study showed a statistically significant difference in failure rate between observation (45%) and brace (15%) treatment (P < .001). Findings with respect to posttreatment quality of life at 2 years were inconsistent. Two studies favored the brace group, and one the observation group using the SRS-22 and Quality of Life Profile for Spine Deformities (QLPSD) measures. Two of three studies reporting pretreatment and posttreatment curve angles demonstrated a treatment effect favoring bracing; however, statistical significance for these treatment effects could not be calculated. One study described a treatment effect favoring observation but the differences were not statistically significant (P = .26). CONCLUSION: This systematic review identified and summarized only the highest level of evidence by limiting to comparison studies. Case-series were not included. This allowed for comparisons among the same patient populations. Findings with respect to surgical rates, quality of life, and change in curve angle demonstrate either no significant differences or inconsistent findings favoring one treatment or the other. If bracing does not cause a positive treatment effect, then its rejection will lead to significant savings for healthcare providers and purchasers. Given the very low to low level of evidence and inconsistent findings, a randomized trial is necessary to determine if bracing should be recommended.

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: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:BackgroundThe SRS criteria give the methodological reference framework for the presentation of bracing results, while the SOSORT criteria give the clinical reference framework for an appropriate bracing treatment. The two have not been combined in a study until now. Our aim was to verify the efficacy of a complete, conservative treatment of Adolescent Idiopathic Scoliosis (AIS)according to the best methodological and management criteria defined in the literature.MethodsStudy Design. Retrospective study. Population. We included all AIS patients respecting the SRS inclusion criteria (age 10 years or older; Risser test 0-2; Cobb degrees 25-40 degrees ; no prior treatment; less than one year post-menarchal) who had reached the end of treatment since our institute database start in 2003. Thus we had 44 females and four males, with an age of 12.8 +/- 1.6 at the commencement of the study. Methods. According to individual needs, two patients have been treated with Risser casts followed by Lyon brace, 40 with Lyon or SPoRT braces (14 for 23 hours per day, 23 for 21 h/d, and seven for 18 h/d at start), and two with exercises only (1 male, 1 female): these were excluded from further analysis. Outcome criteria. SRS (unchanged; worsened 6 degrees or more; over 45 degrees at the end of treatment; surgically treated; two years' follow-up); clinical (ATR, Aesthetic Index, plumbline distances); radiographic (Cobb degrees); and ISICO (optimal; minimal). Statistics. Paired ANOVA and t-test, Tukey-Kramer and chi-square test.ResultsMedian reported compliance during the 4.2 +/- 1.4 treatment years was 90% (range 5-106%). No patient progressed beyond 45 degrees , nor was any patient fused, and this remained true at the two-year follow-up for the 85% that reached it. Only two patients (4%) worsened, both with single thoracic curve, 25-30 degrees Cobb and Risser 0 at the start. We found statistically significant reductions of the scoliosis curvatures (-7.1 degrees ): thoracic (-7.3 degrees ), thoracolumbar (-8.4 degrees ) and lumbar (-7.8 degrees ), but not double major. Statistically significant improvements have also been found for aesthetics and ATR.ConclusionRespecting also SOSORT management criteria and thus increasing compliance, the results of conservative treatment were much better than what had previously been reported in the literature using SRS criteria only.

Project description:BackgroundEnhanced recovery after surgery protocols increasingly use multimodal analgesia after major surgeries with intravenous acetaminophen and ketorolac, despite no documented cost-effectiveness of these strategies.AimsThe goal of this prospective cohort study was to model cost-effectiveness of adding acetaminophen or acetaminophen + ketorolac to opioids for postoperative outcomes in children having scoliosis surgery.MethodsOf 106 postsurgical children, 36 received only opioids, 26 received intravenous acetaminophen, and 44 received acetaminophen + ketorolac as analgesia adjuncts. Costs were calculated in 2015 US $. Decision analytic model was constructed with Decision Maker® software. Base-case and sensitivity analyses were performed with effectiveness defined as avoidance of opioid adverse effects.ResultsThe groups were comparable demographically. Compared with opioids-only strategy, subjects in the intravenous acetaminophen + ketorolac strategy consumed less opioids (P = .002; difference in mean morphine consumption on postoperative days 1 and 2 was -0.44 mg/kg (95% CI -0.72 to -0.16); tolerated meals earlier (P < .001; RR 0.250 (0.112-0.556)) and had less constipation (P < .001; RR 0.226 (0.094-0.546)). Base-case analysis showed that of the 3 strategies, use of opioids alone is both most costly and least effective, opioids + intravenous acetaminophen is intermediate in both cost and effectiveness; and opioids + intravenous acetaminophen and ketorolac is the least expensive and most effective strategy. The addition of intravenous acetaminophen with or without ketorolac to an opioid-only strategy saves $510-$947 per patient undergoing spine surgery and decreases opioid side effects.ConclusionIntravenous acetaminophen with or without ketorolac reduced opioid consumption, opioid-related adverse effects, length of stay, and thereby cost of care following idiopathic scoliosis in adolescents compared with opioids-alone postoperative analgesia strategy.

Project description:BackgroundNon-surgical interventions for adolescents with idiopathic scoliosis remain highly controversial. Despite the publication of numerous reviews no explicit methodological evaluation of papers labeled as, or having a layout of, a systematic review, addressing this subject matter, is available.ObjectivesAnalysis and comparison of the content, methodology, and evidence-base from systematic reviews regarding non-surgical interventions for adolescents with idiopathic scoliosis.DesignSystematic overview of systematic reviews.MethodsArticles meeting the minimal criteria for a systematic review, regarding any non-surgical intervention for adolescent idiopathic scoliosis, with any outcomes measured, were included. Multiple general and systematic review specific databases, guideline registries, reference lists and websites of institutions were searched. The AMSTAR tool was used to critically appraise the methodology, and the Oxford Centre for Evidence Based Medicine and the Joanna Briggs Institute's hierarchies were applied to analyze the levels of evidence from included reviews.ResultsFrom 469 citations, twenty one papers were included for analysis. Five reviews assessed the effectiveness of scoliosis-specific exercise treatments, four assessed manual therapies, five evaluated bracing, four assessed different combinations of interventions, and one evaluated usual physical activity. Two reviews addressed the adverse effects of bracing. Two papers were high quality Cochrane reviews, Three were of moderate, and the remaining sixteen were of low or very low methodological quality. The level of evidence of these reviews ranged from 1 or 1+ to 4, and in some reviews, due to their low methodological quality and/or poor reporting, this could not be established.ConclusionsHigher quality reviews indicate that generally there is insufficient evidence to make a judgment on whether non-surgical interventions in adolescent idiopathic scoliosis are effective. Papers labeled as systematic reviews need to be considered in terms of their methodological rigor; otherwise they may be mistakenly regarded as high quality sources of evidence.Protocol registry numberCRD42013003538, PROSPERO.

Project description:Recently an RCT confirmed brace efficacy in adolescent idiopathic scoliosis (AIS) patients. Previously, a Cochrane review suggested also producing studies according to the Scoliosis Research Society (SRS) criteria on the effectiveness of bracing for AIS. Even if the SRS criteria propose a prospective design, until now only one out of 6 published studies was prospective. Our purpose was to evaluate the effects of bracing plus exercises following the SRS and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria for AIS conservative treatment.prospective cohort study nested in a clinical database of all outpatients of a clinic specialized in scoliosis conservative treatment.seventy-three patients (60 females), age 12 years 10 months ±17 months, 34.4±4.4 Cobb degrees, who satisfied SRS criteria were included out of 3,883 patients at first evaluation.Cobb angle at the end of treatment according to SRS criteria : (unchanged; worsened 6° or more, over 45° and surgically treated, and rate of improvement of 6° or more).Braces were prescribed for 18-23 hours/day according to curves magnitude and actual international guidelines. Weaning was gradual after Risser 3. All patients performed exercises and were managed according to SOSORT criteria. Results in all patients were analyzed according to intent-to-treat at the end of the treatment. Funding and Conflict of Interest: no.Overall 34 patients (52.3%) improved. Seven patients (9.6%) worsened, of which 1 patient progressed beyond 45° and was fused. Referred compliance was assessed during a mean period of 3 years 4 months ±20 months; the median adherence was 99.1% (range 22.2-109.2%). Employing intent-to-treat analysis, there were failures in 11 patients (15.1%). At start, these patients had statistically significant low BMI and kyphosis, high thoracic rotation and higher Cobb angles. Drop-outs showed reduced compliance and years of treatment; their average scoliosis at discontinuation was low: 22.7° (range 16-35°) at Risser 1.3 ± 1.Bracing in patients with AIS who satisfy SRS criteria is effective. Combining bracing with exercise according to SOSORT criteria shows better results than the current literature.

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Effects of bracing in adolescents with idiopathic scoliosis.

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Effects of bracing in adolescents with idiopathic scoliosis.

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