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Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.

ABSTRACT: The North American non-surgical standard of care for adolescent idiopathic scoliosis (AIS) includes observation and bracing, but not exercises. Schroth physiotherapeutic scoliosis-specific exercises (PSSE) showed promise in several studies of suboptimal methodology. The Scoliosis Research Society calls for rigorous studies supporting the role of exercises before including it as a treatment recommendation for scoliosis.To determine the effect of a six-month Schroth PSSE intervention added to standard of care (Experimental group) on the Cobb angle compared to standard of care alone (Control group) in patients with AIS.Fifty patients with AIS aged 10-18 years, with curves of 10°-45° and Risser grade 0-5 were recruited from a single pediatric scoliosis clinic and randomized to the Experimental or Control group. Outcomes included the change in the Cobb angles of the Largest Curve and Sum of Curves from baseline to six months. The intervention consisted of a 30-45 minute daily home program and weekly supervised sessions. Intention-to-treat and per protocol linear mixed effects model analyses are reported.In the intention-to-treat analysis, after six months, the Schroth group had significantly smaller Largest Curve than controls (-3.5°, 95% CI -1.1° to -5.9°, p = 0.006). Likewise, the between-group difference in the square root of the Sum of Curves was -0.40°, (95% CI -0.03° to -0.8°, p = 0.046), suggesting that an average patient with 51.2° at baseline, will have a 49.3° Sum of Curves at six months in the Schroth group, and 55.1° in the control group with the difference between groups increasing with severity. Per protocol analyses produced similar, but larger differences: Largest Curve = -4.1° (95% CI -1.7° to -6.5°, p = 0.002) and [Formula: see text] (95% CI -0.8 to 0.2, p = 0.006).Schroth PSSE added to the standard of care were superior compared to standard of care alone for reducing the curve severity in patients with AIS.NCT01610908.

SUBMITTER: Schreiber S

PROVIDER: S-EPMC5198985 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.

Schreiber Sanja S Parent Eric C EC Khodayari Moez Elham E Hedden Douglas M DM Hill Douglas L DL Moreau Marc M Lou Edmond E Watkins Elise M EM Southon Sarah C SC

PloS one 20161229 12

<h4>Background</h4>The North American non-surgical standard of care for adolescent idiopathic scoliosis (AIS) includes observation and bracing, but not exercises. Schroth physiotherapeutic scoliosis-specific exercises (PSSE) showed promise in several studies of suboptimal methodology. The Scoliosis Research Society calls for rigorous studies supporting the role of exercises before including it as a treatment recommendation for scoliosis.<h4>Objectives</h4>To determine the effect of a six-month S ...[more]

PMID: 28033399

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Project description:BackgroundIn North America, care recommendations for adolescents with small idiopathic scoliosis (AIS) curves include observation or bracing. Schroth scoliosis-specific exercises have demonstrated promising results on various outcomes in uncontrolled studies. This randomized controlled trial (RCT) aimed to determine the effect of Schroth exercises combined with the standard of care on quality-of-life (QOL) outcomes and back muscle endurance (BME) compared to standard of care alone in patients with AIS.Material and methodsFifty patients with AIS, aged 10-18 years, with curves 10-45 °, recruited from a scoliosis clinic were randomized to receive standard of care or supervised Schroth exercises plus standard of care for 6 months. Schroth exercises were taught over five sessions in the first two weeks. A daily home program was adjusted during weekly supervised sessions. The assessor and the statistician were blinded. Outcomes included the Biering-Sorensen (BME) test, Scoliosis Research Society (SRS-22r) and Spinal Appearance Questionnaires (SAQ) scores. Intention-to-treat (ITT) and per protocol (PP) linear mixed effects models were analyzed. Because ITT and PP analyses produced similar results, only ITT is reported.ResultsAfter 3 months, BME in the Schroth group improved by 32.3 s, and in the control by 4.8 s. This 27.5 s difference in change between groups was statically significant (95 % CI 1.1 to 53.8 s, p = 0.04). From 3 to 6 months, the self-image improved in the Schroth group by 0.13 and deteriorated in the control by 0.17 (0.3, 95 % CI 0.01 to 0.59, p = 0.049). A difference between groups for the change in the SRS-22r pain score transformed to its power of four was observed from 3 to 6 months (85.3, 95 % CI 8.1 to 162.5, p = 0.03), where (SRS-22 pain score)(4) increased by 65.3 in the Schroth and decreased by 20.0 in the control group. Covariates: age, self-efficacy, brace-wear, Schroth classification, and height had significant main effects on some outcomes. Baseline ceiling effects were high: SRS-22r (pain = 18.4 %, function = 28.6 %), and SAQ (prominence = 26.5 %, waist = 29.2 %, chest = 46.9 %, trunk shift = 12.2 % and shoulders = 18.4 %).ConclusionsSupervised Schroth exercises provided added benefit to the standard of care by improving SRS-22r pain, self-image scores and BME. Given the high prevalence of ceiling effects on SRS-22r and SAQ questionnaires' domains, we hypothesize that in the AIS population receiving conservative treatments, different QOL questionnaires with adequate responsiveness are needed.Trial registrationSchroth Exercise Trial for Scoliosis NCT01610908.

Project description:Background:Recent randomized controlled trials (RCTs) support using physiotherapeutic scoliosis-specific exercises (PSSE) for adolescents with idiopathic scoliosis (AIS). All RCTs reported statistically significant results favouring PSSE but none reported on clinical significance. The number needed to treat (NNT) helps determine if RCT results are clinically meaningful. The NNT is the number of patients that need to be treated to prevent one bad outcome in a given period. A low NNT suggests that a therapy has positive outcomes in most patients offered the therapy. The objective was to determine how many patients require Schroth PSSE added to standard care (observation or brace treatment) to prevent one progression (NNT) of the Largest Curve (LC) or Sum of Curves (SOC) beyond 5° and 10°, respectively over a 6-month interval. Methods:This was a secondary analysis of a RCT. Fifty consecutive participants from a scoliosis clinic were randomized to the Schroth PSSE + standard of care group (n = 25) or the standard of care group (n = 25).We included males and females with AIS, age 10-18 years, all curve types, with curves 10°- 45°, with or without brace, and all maturity levels. We excluded patients awaiting surgery, having had surgery, having completed brace treatment and with other scoliosis diagnoses. The local ethics review board approved the study (Pro00011552).The Schroth intervention consisted of weekly 1-h supervised Schroth PSSE sessions and a daily home program delivered over six months in addition to the standard of care. A prescription algorithm was used to determine which exercises patients were to perform. Controls received only standard of care.Cobb angles were measured using a semi-automatic system from posterior-anterior standing radiographs at baseline and 6 months.We calculated absolute risk reduction (ARR) and relative risk reduction (RRR). The NTT was calculated as: NNT = 1/ARR. Patients with missing values (PSSE group; n = 2 and controls; n = 4) were assumed to have had curve progression (worst case scenario). The RRR is calculated as RRR = ARR/CER. Results:For LC, NNT = 3.6 (95% CI 2.0-28.2), and for SOC, NNT = 3.1 (95% CI 1.9-14.2). The corresponding ARR was 28% for LC and 32% for the SOC. The RRR was 70% for LC and 73% for the SOC. Patients with complete follow-up attended 85% of prescribed visits and completed 82.5% of the home program. Assuming zero compliance after dropout, 76% of visits were attended and 73% of the prescribed home exercises were completed. Conclusions:The short term of Schroth PSSE intervention added to standard care provided a large benefit as compared to standard care alone. Four (LC and SOC) patients require treatment for the additional benefit of a 6-month long Schroth intervention to be observed beyond the standard of care in at least one patient. Trial registration:NCT01610908 April 2, 2012.

Project description:BackgroundFinding an optimal treatment strategy for adolescent idiopathic scoliosis (AIS) patients remains challenging because of its intrinsic complexity. For mild to moderate scoliosis patients with lower skeletal growth potential (Risser 3-5), most clinicians agree with observation treatment; however, the curve progression that occurs during puberty, the adolescent period, and even in adulthood, remains a challenging issue for clinicians. The aim of the study is to investigate the efficacy of Schroth exercise in AIS patients with lower skeletal growth potential (Risser 3-5) and moderate scoliosis (Cobb angle 20°-40°).MethodsFrom 2015 to 2017, data of 64 patients diagnosed with AIS in Peking University Third Hospital were reviewed. Forty-three patients underwent Schroth exercise were classified as Schroth group, and 21 patients underwent observation were classified as observation group. Outcomes were measured by health-related quality of life (HRQOL) and radiographic parameters. HRQOL was assessed using the visual analog scale (VAS) scores for back, Scoliosis Research Society-22 (SRS-22) patient questionnaire. Radiographic spinopelvic parameters were obtained from anteroposterior and lateral X-rays. The pre-treatment and post-treatment HRQOL and radiographic parameters were tested to validate Schroth exercise efficacy. The inter-rater reliability of the radiographic parameters was tested using the interclass correlation coefficient (ICC). The paired t test was used to examine HRQOL and radiographic parameters. Clinical relevance between C2-C7 sagittal vertical axis (SVA) and thoracic kyphosis was analyzed using Spearman correlation.ResultsIn Schroth group, VAS back score, SRS-22 pain, and SRS-22 self-image domain were significantly improved from pre-treatment 3.0 ± 0.8, 3.6 ± 0.5, and 3.5 ± 0.7 to post-treatment 1.6 ± 0.6 (t = 5.578, P = 0.013), 4.0 ± 0.3 (t = -3.918, P = 0.001), and 3.7 ± 0.4 (t = -6.468, P < 0.001), respectively. No significant improvements of SRS-22 function domain (t = -2.825, P = 0.088) and mental health domain (t = -3.174, P = 0.061) were observed. The mean Cobb angle decreased from 28.9 ± 5.5° to 26.3 ± 5.2° at the final follow-up, despite no statistical significance was observed (t = 1.853, P = 0.102). The mean C2-C7 SVA value decreased from 21.7 ± 8.4 mm to 17.0 ± 8.0 mm (t = -1.224 P = 0.049) and mean T1 tilt decreased from 4.9 ± 4.2 ° to 3.5 ± 3.1° (t = 2.913, P = 0.011). No significant improvement of radiographic parameters and HRQOL were observed in observation group.ConclusionsFor AIS patients with a Risser 3-5 and a Cobb angle 20°-40°, Schroth exercises improved HRQOL and halted curve progression during the follow-up period. Both cervical spine alignment and shoulder balance were also significantly improved after Schroth exercises. We recommend Schroth exercises for patients with AIS.

Project description:BACKGROUND:The Cobb angle is proposed as the "disease process" outcome for scoliosis research because therapies aim to correct or stop curve progression. While the Scoliosis Research Society recommends the Cobb angle as the primary outcome, the Society on Scoliosis Orthopaedic and Rehabilitation Treatment prioritises, as a general goal, patient related outcomes over Cobb angle progression. OBJECTIVE:To determine the threshold of change in the Cobb angle in adolescents with idiopathic scoliosis (AIS) who perceive improvement in a 6-months randomized controlled trial comparing a Schroth exercise intervention added to the standard of care to the standard of care alone. METHODS:This is a secondary analysis of data from a randomized controlled trial of 50 patients with AIS, with curves ranging from 10° to 45°, with or without a brace. Participants with diagnoses other than AIS, surgical candidates or patients who had scoliosis surgery were excluded. The 6-month interventions consisted of Schroth exercises added to standard-of-care (observation or bracing) with daily home exercises and weekly therapy sessions (Schroth) or standard-of-care alone (Control). The anchor method for estimating the minimal important difference (MID) in the largest Cobb angles (LC) was used. Patient-reported change in back status over the 6-month treatment period was measured using the Global Rating of Change (GRC) scale as anchor varying from -?7 ("great deal worse") to +?7 ("great deal better"). Participants were divided into two groups based on GRC scores: Improved (GRC ?2) or Stable/Not Improved (GRC ?1). MID was defined as the change in the LC that most accurately predicted the GRC classification as per the receiver operating characteristic curve (ROC). RESULTS:The average age was 13.4?±?1.6?years and the average LC was 28.5?±?8.8 °s. The average GRC in the control group was -?0.1?±?1.6, compared to +?4.4?±?2.2 in the Schroth group. The correlation between LC and GRC was adequate (r?=?-?0.34, p?<?0.05). The MID for the LC was 1.0 °. The area under the ROC was 0.69 (0.52-0.86), suggesting a 70% chance to properly classify a patient as perceiving No Improvement/Stable or Improvement based on the change in the LC. CONCLUSION:Patients undergoing Schroth treatment perceived improved status of their backs even if the Cobb angle did not improve beyond the conventionally accepted threshold of 5°. Standard of care aims to slow/stop progression while Schroth exercises aim to improve postural balance, signs and symptoms of scoliosis. Given the very small MID, perceived improvement in back status is likely due to something other than the Cobb angle. This study warrants investigating alternatives to the Cobb angle that might be more relevant to patients. TRIAL REGISTRATION:ClinicalTrials.gov , NCT01610908 . Retrospectively registered on April 2, 2012 (first posted on June 4, 2012 - https://clinicaltrials.gov/ct2/keydates/NCT01610908 ).

Project description:BACKGROUND:Supine imaging modalities provide valuable 3D information on scoliotic anatomy, but the altered spine geometry between the supine and standing positions affects the Cobb angle measurement. Previous studies report a mean 7°-10° Cobb angle increase from supine to standing, but none have reported the effect of endplate pre-selection or whether other parameters affect this Cobb angle difference. METHODS:Cobb angles from existing coronal radiographs were compared to those on existing low-dose CT scans taken within three months of the reference radiograph for a group of females with adolescent idiopathic scoliosis. Reformatted coronal CT images were used to measure supine Cobb angles with and without endplate pre-selection (end-plates selected from the radiographs) by two observers on three separate occasions. Inter and intra-observer measurement variability were assessed. Multi-linear regression was used to investigate whether there was a relationship between supine to standing Cobb angle change and eight variables: patient age, mass, standing Cobb angle, Risser sign, ligament laxity, Lenke type, fulcrum flexibility and time delay between radiograph and CT scan. RESULTS:Fifty-two patients with right thoracic Lenke Type 1 curves and mean age 14.6 years (SD 1.8) were included. The mean Cobb angle on standing radiographs was 51.9° (SD 6.7). The mean Cobb angle on supine CT images without pre-selection of endplates was 41.1° (SD 6.4). The mean Cobb angle on supine CT images with endplate pre-selection was 40.5° (SD 6.6). Pre-selecting vertebral endplates increased the mean Cobb change by 0.6° (SD 2.3, range -9° to 6°). When free to do so, observers chose different levels for the end vertebrae in 39% of cases. Multi-linear regression revealed a statistically significant relationship between supine to standing Cobb change and fulcrum flexibility (p = 0.001), age (p = 0.027) and standing Cobb angle (p < 0.001). The 95% confidence intervals for intra-observer and inter-observer measurement variability were 3.1° and 3.6°, respectively. CONCLUSIONS:Pre-selecting vertebral endplates causes minor changes to the mean supine to standing Cobb change. There is a statistically significant relationship between supine to standing Cobb change and fulcrum flexibility such that this difference can be considered a potential alternative measure of spinal flexibility.

Project description:BackgroundSpinal manipulative therapy is commonly used in the treatment of adolescent idiopathic scoliosis. Some therapists also rely on physiotherapeutic scoliosis-specific exercise (PSSE). Combining these two modalities seems reasonable, but the effectiveness of this combination has never been rigorously tested. Here, a protocol for a pilot study is proposed to determine the feasibility of conducting a larger randomized trial. The pilot study was designed to test the hypothesis that spinal manipulative therapy followed by PSSE is more effective than PSSE alone in improving the Cobb angle, sensorimotor integration, the angle of trunk rotation (ATR), body symmetry, and quality of life.MethodsThe protocol describes a randomized controlled pilot trial with 40 subjects divided into study and control groups. Both groups will receive 8 weeks of PSSE, but the study group will also receive spinal manipulative therapy during the first 2 weeks before PSSE. The primary outcome will be an estimate of the feasibility of conducting a full-scale experiment. The influencing factors will be the time to complete enrollment, the recruitment rate, subject retention, and adherence to the treatment allocations. The secondary outcomes that will be used to assess the efficacy of treatment will include the Cobb angle, somatosensory evoked potentials, ATR, three-dimensional postural parameters, and scores on the 22-item Scoliosis Research Society outcomes questionnaire. The Cobb angle will be measured at baseline and at the end of 8 weeks of training. The somatosensory evoked potentials will be measured at baseline and at the end of 2 weeks of training. The ATR, three-dimensional postural parameters, and scores on the 22-item Scoliosis Research Society outcomes questionnaire will be measured at baseline and at 2 weeks, 4 weeks, and 8 weeks of treatment.DiscussionThis study will inform the design of a future full-scale trial. The outcomes will provide preliminary data about the efficacy of the combination of spinal manipulative therapy and exercise in treating scoliosis.Trial registrationProspectively registered at Chinese clinical trial registry, ChiCTR1900027037 . Registered on 29 October 2019. http://www.chictr.org.cn/edit.aspx?pid=44954&htm=4.

Project description:BackgroundMajor depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population.MethodsWe conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789).FindingsThe intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01-2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance.InterpretationAs opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice.FundingThe study was funded by the Italian Medicines Agency within the "2016 Call for Independent Drug Research".

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Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.

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Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial.

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