Abstract

BackgroundRecent 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.MethodsThis 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/CERResultsFor 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.ConclusionsThe 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 registrationNCT01610908 April 2, 2012

Highlights

  • Recent randomized controlled trials (RCTs) support using physiotherapeutic scoliosis-specific exercises (PSSE) for adolescents with idiopathic scoliosis (AIS)

  • Several randomized controlled trials (RCT) investigating the effect of PSSE in adolescents with idiopathic scoliosis (AIS) have been published. In their long-term RCT found that PSSE consisting of active selfcorrection and task-oriented exercises, consistent with Scientific Exercise Approach to Scoliosis (SEAS) [1, 2] improved Cobb angles by 5.3° at skeletal maturity in patients with AIS, while traditional exercises were associated with stable curves

  • [3] Kuru et al, in their 6-month long RCT [4] in patients with AIS concluded that Schroth PSSE improved the Cobb angle by 2.5° in the supervised group, while the patients who were not supervised deteriorated by 3.3° which was similar to controls receiving no treatment [4]

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Summary

Introduction

Recent randomized controlled trials (RCTs) support using physiotherapeutic scoliosis-specific exercises (PSSE) for adolescents with idiopathic scoliosis (AIS). [5] Monticone et al in an RCT conducted on adults with idiopathic scoliosis with childhood onset undergoing a 20-week long SEAS PSSE or usual physiotherapy, found that the Cobb angle in the experimental group improved by 2.9° and in the control group deteriorated by 2.1° [6] All these RCTs reported statistically significant results favouring PSSE but none reported on clinical significance. One definition is “the extent to which therapy moves someone outside the range of scores typical of the dysfunctional population or within the range of the functional population” [12] Another one states that “a clinically significant change is a difference score that is large enough to have an implication for the patient's treatment or care” [15]. In an effort to evaluate whether the treatment has had a clinically significant effect on a patient’s outcome variable, several approaches have been proposed

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