Status in Scotland
- A methodologically robust meta-analysis of seven studies (n=751) found that adolescents with idiopathic scoliosis receiving orthotic bracing had a higher rate of successful outcomes: odds ratio (OR) 3.58, 95% confidence interval (CI) 1.92 to 6.68. Patients treated with bracing also had a significantly better quality of life (mean difference 2.13, 95% CI 0.51 to 3.75), and a higher adverse event rate (OR 5.31, 95% CI 2.42 to 11.66) than patients who did not undergo bracing.
- A Cochrane systematic review that did not include a meta-analysis due to high heterogeneity between studies considered the evidence to be of low or very low quality and had low confidence in the review findings. The review authors reported significantly higher success rates (curve remaining below 50°) with bracing compared with observation in three studies (n=415) in adolescent patients with idiopathic scoliosis. Two studies (n=347) in the review found no statistically significant differences in quality of life between the two groups. One study (n=242) found no significant differences in adverse events between bracing and observation.
- One meta-analysis and two low quality systematic reviews compared night-time bracing with fulltime bracing in adolescent patients with idiopathic scoliosis. The low quality of the primary studies and substantial heterogeneity meant it was not possible to reach any conclusions on whether night-time bracing is as effective as fulltime bracing in this patient population.
- Back pain was the most commonly reported adverse event in patients undergoing orthotic bracing for scoliosis. Results presented in the literature were variable, therefore it is uncertain what effect bracing has on back pain prevalence or severity in patients with adolescent idiopathic scoliosis.
- A systematic review with methodological limitations identified three main risk factors associated with the failure of orthotic bracing in adolescents with idiopathic scoliosis: lower adherence to the prescribed bracing regimen, low levels of skeletal maturity at the time of bracing (patients are younger and still growing), and spinal curvature (Cobb angle) >30° at initial bracing.
- The duration of brace wearing per day affects the effectiveness of the treatment. In a low quality literature review, rates of adherence to prescribed bracing regimens were affected by patient age, the type and fit of the brace, the appearance of the brace, and whether the patient wore the brace at night only or during the day.
- In one systematic review, nine observational studies of unclear quality suggested that overall levels of stress, anxiety and depression were low to moderate amongst adolescents with idiopathic scoliosis treated using bracing, surgery or physiotherapy.
- Twenty-four studies in a systematic review consistently reported negative effects on perceived body image among patients with adolescent idiopathic scoliosis.
- Based on a single study from the United States (US), bracing in patients with adolescent idiopathic scoliosis may be a cost-effective treatment option, generating more quality adjusted life years (+0.22 QALYs) at a lower cost (-$24,903 [approximately £21,057]) compared with observation. The high cost of surgery is a significant driver of the results; the cost effectiveness of bracing is based on an assumed reduction in the need for surgery in patients treated with bracing.
- A comprehensive cost-effectiveness analysis for Scotland is not available so the results from the US study should be treated with caution.
- Scotland-specific costings indicate that the cost of bracing and surgery account for a similar fraction of the costs as described in the US study and thus may not alter the estimated life-time incremental costs in the published economic model.
What were we asked to look at?
SHTG was asked to review the published literature on the clinical effectiveness, cost effectiveness and safety of orthotic bracing for the treatment of children and young people (<18 years) who have been diagnosed with idiopathic scoliosis. The Scottish National Spine Service (SNSS) is a national designated specialist service and this work was requested by NHS National Services Scotland (NSS) to inform future service delivery by the SNSS.
Why is this important
The SNSS cares for children and young people diagnosed with disorders of the spine, including scoliosis. Orthotic bracing is one treatment option for patients with idiopathic scoliosis who are skeletally immature (they are still growing). Bracing may be able to slow down progression of the abnormal curvature of the spine and postpone or eliminate the need for major surgeries to fuse and realign the spine. Repeated surgery for scoliosis in young children can have negative effects on their mental health and wellbeing, which could be mitigated by postponing or eliminating the need for surgery.
National Services Division (NSD) and clinical experts from the Scottish National Spine Service (SNSS)