Efficacy of bracing versus observation in the treatment of idiopathic scoliosis

ABSTRACT

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.

STUDY RATIONALE AND CONTEXT Bracing of patients with idiopathic scoliosis remains an evocative subject. There are strong advocates and skeptics. The aim of bracing is to prevent curve deterioration and surgical intervention. However, it is still a treatment that can adversely affect the individual patient. Often, a patient with a small curve may have a spinal deformity unrecognizable to their friends and peer group. This occurs at a time for most patients when appearing different can lead to significant negative consequences. Bracing in itself may create an illness behavior. By making the problem more visible this may highlight the condition to other individuals. The negative result of a brace can be offset if its clinical effect causes a treatment outcome that stops major surgical intervention and risk exposure. However, if the brace does not prevent surgery or curve progression then the economic costs to society and the negative psychological and social effects of wearing a brace cause a morbidity that should be avoided. There has been little done in the way of systematic reviews using only high-level evidence studies or meta-analyses comparing brace treatment with observation in the past. Several systematic reviews have compared bracing with observation 1, 2, 3. Negrini et al 1 only included two studies; one comparing brace treatment to observation and one comparing two different brace types. They concluded that there was very low quality of evidence supporting brace treatment. Weiss and Goodall 2 compared several different treatments—physical therapy, inpatient rehabilitation, bracing, and surgery to the natural history of idiopathic scoliosis. They concluded that there was some evidence of a better scientific standard supporting inpatient rehabilitation and bracing for the treatment of idiopathic scoliosis. Finally, Lenssinck et al 3 compared various conservative treatments, such as bracing, electrical stimulation, and exercise. They concluded that because of the low-level quality studies, it is hard to draw firm conclusions. However, the effectiveness of bracing is promising, but not yet established. In one meta-analysis, Rowe et al 4 compared different kinds of bracing with electrical stimulation and observation. However, only one study with observation was included. All other studies compared different types of braces and electrical stimulation. Their conclusions support the effectiveness of bracing for treating idiopathic scoliosis. None of the previous systematic reviews included surgical rates, failure rates, curve-angle changes, and patient-centered quality of life (QoL) outcomes together in the same review. Therefore, our aim was to compare brace treatment with observation only with respect to all these measures in the treatment of idiopathic scoliosis. 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 QoL 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? MATERIALS AND METHODS Study design: Systematic review. Sampling: Search: PubMed, Cochrane collaboration database, and National Guideline Clearinghouse databases; bibliographies of key articles. Dates searched: 1970 – December 2010. Inclusion criteria: Patients with adolescent idiopathic scoliosis. Randomized controlled trials (RCTs) and nonrandomized comparison studies. Exclusion criteria: Scoliosis from any other causes; adult patients; adjunct treatments such as electrical stimulation; case-series and studies with historical controls. Outcomes: Surgery rates, failure rates, QoL, and curve-angle changes. Analysis: Descriptive statistics. Study-level surgical rate data was combined to calculate pooled surgical rates and risk differences (between the two groups) with 95% confidence intervals. Change scores for studies reporting pretreatment and posttreatment QoL and curve angles were computed. Treatment effects (ie, effects of bracing versus observation) were calculated by subtracting change scores. Data could not be pooled due to the heterogeneity of outcome measures and absence of preoperative and postoperative standard deviations. Details about methods can be found in the web appendix at www.aospine.org / ebsj.

REFERENCES

• 1 Negrini S, Minozzi S, Bettany-Saltikov J. et al . Braces for idiopathic scoliosis in adolescents.  Spine (Phila Pa 1976). 2010;  35 1285-1293
• 2 Weiss H R, Goodall D. The treatment of adolescent idiopathic scoliosis (AIS) according to present evidence: a systematic review.  Eur J Phys Rehabil Med. 2008;  44 (2) 177-193
• 3 Lenssinck M L, Frijlink A C, Berger M Y. et al . Effect of bracing and other conservative interventions in the treatment of idiopathic scoliosis in adolescents: a systematic review of clinical trials.  Phys Ther. 2005;  85 (12) 1329-1339
• 4 Rowe D E, Bernstein S M, Riddick M F. et al . A meta-analysis of the efficacy of non-operative treatments for idiopathic scoliosis.  J Bone Joint Surg Am. 1997;  79 (5) 664-674
• 5 Nachemson A L, Peterson L E. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis: a prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society.  J Bone Joint Surg Am. 1995;  77 (6) 815-822
• 6 Danielsson A J, Hasserius R, Ohlin A. et al . A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of 16 years after maturity.  Spine (Phila Pa 1976). 2007;  32 2198-2207
• 7 Fernandez-Feliberti R, Flynn J, Ramirez N. et al . Effectiveness of TLSO bracing in the conservative treatment of idiopathic scoliosis.  J Pediatr Orthop. 1995;  15 176-181
• 8 Cheung K M, Cheng E Y, Chan S C. et al . Outcome assessment of bracing in adolescent idiopathic scoliosis by the use of the SRS-22 questionnaire.  Int Orthop. 2007;  31 (4) 507-511
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EDITORIAL PERSPECTIVE

The reviewers found the article interesting and relevant but noted that there had been previous attempts at meta-analysis, most recently in Lancet 2008 by S Weinstein et al [1] using the Cochrane review and Medline from 1996 – 2006 and by Sponseller in 2011 [2]. It should, however, be noted that the Weinstein systematic review is primarily a summary of case series from both treatment arms that reduces the level of evidence of their findings substantially.

Only one of the studies (Fernandez-Feliberti, 1995) used in the systematic review by Weinstein [1] was also used in the published EBSJ systematic review, which includes 8 articles: Mannherz (1988); Nachemson (1995); Fernandez-Feliberti (1995); Ugwonali (2004); Cheung (2006); Pham (2008); Danielsson (2007); Parent (2009).

In addition, the Weinstein article [2] consisted of a review of surgical techniques versus bracing without mention of observation only. As to the Sponseller article [2], its creation coincided with the writing of the present EBSJ article. Its main focus was aimed at identifying consensus for indications for bracing.

The reviewers concur with the EBSJ authors' conclusion that the evidence for bracing in the treatment of adolescent idiopathic scoliosis (AIS) is—at best—marginal. Despite a literal explosion of publications on the subject of AIS in the general literature and a steadily growing body of studies in the orthopaedic literature there remains a paucity of clarity. There are two current well-funded and well-controlled prospective trials under way in North America, but it will likely be many years before any conclusions can be reached.

Are there then patients well suited for bracing using a best practices standard? The present EBSJ systematic review was not designed to provide any directed help in this regard.

Sponseller in his recent review suggests that patients with AIS curves between 25 to 45 degrees during their Risser 0 to 1 status should be considered for initial bracing [2]. He goes on to suggest that patients of Risser scores 2 or 3 and curves of 30 – 45 degrees may be offered bracing on their initial visits.

This recommendation, however, is again tempered by questions surrounding the reliability of the Risser sign, thus limiting the validity of these recommendations. Patient compliance with brace wear and brace acceptance remains another important variable, which cannot be fully accounted for despite technological advances, such as thermal scanners and electrical impedance measuring devices.

Finally, the reviewers noted that the authors of the EBSJ systematic review touched upon, but did not elaborate on the importance of cultural expectations, family dynamics, and physician-interactions in the determination for or against bracing. Both, the Sponseller review [2] and the Weinstein review [1] recommended a shared decision-making model to be used. The effects of a shared decision-making model in regards to patient outcomes and conversion rates to surgery of patients presenting with adolescent idiopathic scoliosis remain unknown. In terms of study size and long-term dimensions the reviewers recommend reading the Nachemson study from 1995, which was part of the systematic review performed here [3].

1. Weinstein SL, Dolan LA, Cheng JC, et al (2008) Adolescent idiopathic scoliosis. Seminar. Lancet; 371 (9623): 1527 – 1537.

2. Sponseller PD (2011) Bracing for adolescent idiopathic scoliosis in practice today. J Pediatr Orthop; 31 (1Suppl): S53 – S60.

3. Nachemson A, Peterson LE (1995) Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis: a prospective, controlled study based on data from the brace study of the Scoliosis Research Society. J Bone Joint Surg Am; 77: 815 – 822.