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The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner".

ABSTRACT:

Background

In 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 methods

Fifty 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.

Results

After 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 %).

Conclusions

Supervised 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 registration

Schroth Exercise Trial for Scoliosis NCT01610908.

SUBMITTER: Schreiber S

PROVIDER: S-EPMC4582716 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner".

Schreiber Sanja S Parent Eric C EC Moez Elham Khodayari EK Hedden Douglas M DM Hill Doug D Moreau Marc J MJ Lou Edmond E Watkins Elise M EM Southon Sarah C SC

Scoliosis 20150918

<h4>Background</h4>In 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 pa ...[more]

PMID: 26413145

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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: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.

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: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:Over the last years, evidence has accumulated in support of bracing as an effective treatment option in patients with idiopathic scoliosis. Yet, little information is available on the impact of compliance on the outcome of conservative treatment in scoliotic subjects. The aim of the present study was to prospectively evaluate the association between compliance to brace treatment and the progression of scoliotic curve in patients with idiopathic adolescent (AIS) or juvenile scoliosis (JIS).Among 1.424 patients treated for idiopathic scoliosis, 645 were eligible for inclusion criteria. Three outcomes were distinguished in agreement with the SRS criteria: curve correction, curve stabilization and curve progression. Brace wearing was assessed by one orthopaedic surgeon (LA) and scored on a standardized form. Compliance to treatment was categorized as complete (brace worn as prescribed), incomplete A (brace removed for 1 month), incomplete B (brace removed for 2 months), incomplete C (brace removed during school hours), and incomplete D (brace worn overnight only). Chi square test, T test or ANOVA and ANOVA for repeated measures tests were used as statistical tests.The results from our study showed that at follow-up the compliance was: Complete 61.1%; Incomplete A 5.2%; Incomplete B 10.7%; Incomplete C 14.2%; Incomplete D 8.8%. Curve correction was accomplished in 301/319 of Complete, 19/27 Incomplete A, 25/56 Incomplete B, 52/74 Incomplete C, 27/46 Incomplete D. Cobb mean value was 29.8?±?7.5 SD at beginning and 17.1?±?10.9 SD at follow-up. Both Cobb and Perdriolle degree amelioration was significantly higher in patients with complete compliance over all other groups, both in juvenile, both in adolescent scoliosis. In the intention-to-treat analysis, the rate of surgical treatment was 2.1% among patients with definite outcome and 12.1% among those with drop-out. Treatment compliance showed significant interactions with time.Curve progression and referral to surgery are lower in patients with high brace compliance. Bracing discontinuation up to 1 month does not impact on the treatment outcome. Conversely, wearing the brace only overnight is associated with a high rate of curve progression.

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: Bracing could be efficacious, given good compliance and quality of braces. Recently the SOSORT Brace TREATMENT Management Guidelines (SBTMG) have highlighted the perceived importance of the professional teams surrounding braced patients. PURPOSE: To verify the impact of a complete rehabilitation team in the adolescent patient with bracing. MATERIALS AND METHODS: Design. Initial cross-sectional study, followed by a retrospective case-control study. POPULATION: Thirty-eight patients (15.8?±?1.6?years; 26 females; 10 hyperkyphosis, 28 scoliosis of 29.2?±?7.9° Cobb) extracted from a single orthotist database (between January 1, 2008 and September 1, 2009) and treated by the same physician; brace wearing at least 15?hours/day for a minimum of 6?months; age 10 or more. TREATMENT: Braces: Sforzesco, Sibilla, Lapadula or Maguelone. Exercises: SEAS. METHODS: Two questionnaires filled in blindly by patients: SRS-22 and one especially developed and validated with 25 questions on adherence to treatment. Groups (main risk factor): TEAM (private institute: satisfied 44/44 SOSORT criteria; grade of teamwork, "excellent") included 13 patients and NOT 25 (National Health Service Rehabilitation Department: 35/44 SOSORT criteria respected; grade, "insufficient"). RESULTS: TEAM was more compliant to bracing than NOT (97?±?6% vs. 80?±?24%) and performed nearly double the exercises (38?±?12 vs. 20?±?13?minutes/session). The self-reduction of bracing was significant in NOT (from 16.8?±?3.7 to 14.8?±?4.9?hours/day, , P<0.05); TEAM showed a significant reduction in the difficulties due to bracing (from 8.9?±?1.4 to 3.5?±?2.0 in 12?months on a 10-point scale, P<0.05). Pain was perceived by 55% of NOT versus 7% of TEAM (P?<?0.05). The populations did not differ at the baseline studied outcomes. The absence of a good team surrounding the patient increases by five times the risk of reduced compliance to bracing (odds ratio OR 5.5 - 95% confidence interval 95CI 3.6-7.4), along with more than 15 times that of QoL problems (OR 15.7 - 95CI 13.6-17.9) and pain (OR 16.8 - 95CI 14.5-19.1). CONCLUSIONS: Provided the limits of this first study on the topic, the SBTMG seems to be important for brace treatment, influencing pain, QoL and compliance (and so, presumably, final results). Future studies on the topic are advisable.

Project description:BACKGROUND:The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT), that produced its first Guidelines in 2005, felt the need to revise them and increase their scientific quality. The aim is to offer to all professionals and their patients an evidence-based updated review of the actual evidence on conservative treatment of idiopathic scoliosis (CTIS). METHODS:All types of professionals (specialty physicians, and allied health professionals) engaged in CTIS have been involved together with a methodologist and a patient representative. A review of all the relevant literature and of the existing Guidelines have been performed. Documents, recommendations, and practical approach flow charts have been developed according to a Delphi procedure. A methodological and practical review has been made, and a final Consensus Session was held during the 2011 Barcelona SOSORT Meeting. RESULTS:The contents of the document are: methodology; generalities on idiopathic scoliosis; approach to CTIS in different patients, with practical flow-charts; literature review and recommendations on assessment, bracing, physiotherapy, Physiotherapeutic Specific Exercises (PSE) and other CTIS. Sixty-five recommendations have been given, divided in the following topics: Bracing (20 recommendations), PSE to prevent scoliosis progression during growth (8), PSE during brace treatment and surgical therapy (5), Other conservative treatments (3), Respiratory function and exercises (3), Sports activities (6), Assessment (20). No recommendations reached a Strength of Evidence level I; 2 were level II; 7 level III; and 20 level IV; through the Consensus procedure 26 reached level V and 10 level VI. The Strength of Recommendations was Grade A for 13, B for 49 and C for 3; none had grade D. CONCLUSION:These Guidelines have been a big effort of SOSORT to paint the actual situation of CTIS, starting from the evidence, and filling all the gray areas using a scientific method. According to results, it is possible to understand the lack of research in general on CTIS. SOSORT invites researchers to join, and clinicians to develop good research strategies to allow in the future to support or refute these recommendations according to new and stronger evidence.

Dataset Information

The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner".

Background

Material and methods

Results

Conclusions

Trial registration

Publications

The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner".

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