Effect of bracing and other conservative interventions in the treatment of idiopathic scoliosis in adolescents: a systematic review of clinical trials.

According to the Scoliosis Research Society, scoliosis is a lateral deviation of the normal vertical lines of the spine greater than 10 degrees or an in-potency, 3-dimensionalform deviation from the spine, which is accompanied by lateral curvature of the spine with or without a change in the sagittal and axial surfaces. (1) The idiopathic form is a scoliosis with no clear underlying cause. (2) The age of the patient when scoliosis is first identified determines the classification of idiopathic scoliosis. Adolescent idiopathic scoliosis is found between 10 years of age and skeletal maturity. This form accounts for the majority of cases of idiopathic scoliosis. (2)

The prevalence of adolescent idiopathic scoliosis is 2% to 3% of children between 10 and 16 years of age. The ratio of girls to boys is equal in adolescents with spinal curvatures of 10 degrees. With spinal curvatures greater than 30 degrees, the ratio increases to 10 girls for every boy, and the scoliosis in girls tends to progress more often. Only 10% of adolescents diagnosed with scoliosis have curve progression requiring medical intervention. (2) More than 90% of diagnosed cases require only observation with repeated examination during the growing years. (1,3)

Treatment of idiopathic scoliosis is indicated for patients with spinal curvatures greater than 20 degrees. (4) Possible consequences of untreated idiopathic scoliosis in adults are social isolation, limited job opportunities, and lower marriage rates. (2) There is no indication that life-threatening effects occur in adolescent idiopathic scoliosis. (5)

Treatment strategies for idiopathic scoliosis include conservative treatment and surgery. There is consensus about surgical treatment in a minority of patients with spinal curvatures greater than 45 degrees, especially in patients with severe rotational abnormalities. (3) The vast majority of adolescents with idiopathic scoliosis receive conservative care. The most common interventions used in conservative treatment of adolescent idiopathic scoliosis are bracing, electrical stimulation, and exercise therapy. (1,3,6) Overall, the rationale for the choice of type of conservative care is unclear. Recently, the use of bracing to alter the progression of scoliosis or reduce surgery rate has been questioned. (7-9) The literature shows that bracing does not seem to alter the natural history of progressive idiopathic scoliosis or to reduce surgery rate. (7,9)

In a study by Fallstrom et al, (10) more than 50% of patients with adolescent idiopathic scoliosis initially denied their diagnosis. Several authors (10-12) reported that adolescents with scoliosis seem to have a poorer body image perception compared with a control group without scoliosis. Many researchers (11-13) agreed that people with scoliosis experience problems in their psychological and social development. It appears that quality of life, although measured differently in various studies, is affected not only by the presence of but also by the treatment (especially bracing) for adolescent idiopathic scoliosis.(11,13)

Although the majority of adolescents with idiopathic scoliosis are treated conservatively for years with interventions that have a major impact on their quality of life (eg, bracing), no systematic review concerning the effectiveness of conservative care in adolescent idiopathic scoliosis exists. One review (14) has been done, but it cannot be regarded as valid according to the accepted standards of the Cochrane Collaboration.(15) In that review, 20 studies were included, of which just 1 was a controlled trial; all of the other studies were retrospective patient series or case studies. No other reviews on this topic exist. Therefore, we believe that the current evidence for conservative treatment in patients with idiopathic scoliosis is insufficient. The aim of this study was to evaluate the effectiveness of braces and other conservative interventions used in the treatment of adolescent idiopathic scoliosis by systematically reviewing the literature.

Method

Literature Search

The literature was collected using the Cochrane,(15) PubMed, (16) CINAHL, (17) and PEDro (18) databases from inception to December 2003. With the search strategy for identifying randomized controlled trials (RCTs) as described by Robinson and Dickersin, (19) we used the following key words or combination of words to identify the study population and intervention: "braces," "exercise," "exercise movement techniques," "exercise therapy," "exertion," "human activities," "musculoskeletal manipulations," "orthotic devices," "physical therapy techniques," "scoliosis," "spinal curvatures," and "treatment." Two junior reviewers (ML and AF) and 1 senior and experienced reviewer (AV) independently conducted this search. First, titles and abstracts of identified published articles were reviewed.

Selection

The following criteria were used to select studies:

1. The study had to be designed as an RCT or as a controlled clinical trial (CCT). In this review, a study was considered to be a CCT when there was an intervention group, 1 or more control groups (groups not created by randomization), and a baseline measurement and an outcome measurement.

2. Patients were diagnosed with idiopathic scoliosis.

3. The age of the patients was less than 18 years.

4. The treatment included the use of a conservative intervention (which was defined to exclude surgical and pharmacological interventions).

There were no language restrictions. Abstracts, conference reports, and unpublished studies were excluded. For the final selection of the studies, a selection form was used. The 3 reviewers (ML, AF, and AV) independently applied criteria on the full text of all articles that had passed the first eligibility screening.

Quality Assessment

Two reviewers (ML and AF) independently assessed the methodological quality of the studies using the Delphi list (20) followed by a consensus meeting. The Delphi list is a generic criteria list for quality assessment of RCTs and CCTs for conducting systematic reviews developed by Delphi consensus (20) (Tab. 1). Quality was defined as "the likelihood of the trial design to generate unbiased results that are sufficiently precise and allow application in clinical practice." (21)(p651) We choose to use the Delphi list because this criteria list appeared to be valid and reliable and is often used in systematic reviews on musculoskeletal disorders. (21) The Delphi list consists of 9 items. All items have a "yes," "no," or "don't know" answer option. A score of 1 point is given to each item assessed with a "yes" answer. Equal weights were applied, resulting in a maximum score of 9 points for the overall methodological quality score. For feasibility reasons, the assessment was not performed under masked conditions. (22) When disagreement between reviewers concerning the scoring of an item persisted, the third reviewer (AV) made the final decision.

Data Extraction

For each study, a data extraction form was used to make a summary of the study characteristics and outcome measures used. Two reviewers (ML and AF) independently collected the data.

Data Analysis

A quality score was calculated using the Delphi items that scored positive, resulting in a score ranging from 0 to 9. With reference to the influence of different scales used to assess quality and its effect on the conclusion of the systematic review, (2, 3) we sed 2 different ways of defining "high-quality" studies. We defined high quality as: (1) presenting a concealed randomization procedure and adequate blinding or (2) a positive score on 5 or more Delphi items (50% of the maximum attainable score). This way, we tried to minimize the possibility that our conclusion was flawed by misclassification.

We calculated relative risks (RRs) with 95% confidence interval (CIs) for dichotomous variables. Relative risk is a ratio and can vary between 0 and infinity, where an RR of 1 represents no difference between the 2 interventions under study. An RR less than 1 represents a better outcome for the first-mentioned comparison group, and an RR higher than 1 represents a better outcome for the second-mentioned comparison group (often the control group). Statistical pooling was limited to clinically homogeneous studies for which the study populations, interventions, and outcomes were considered to be similar by the reviewers. In case of clinical heterogeneity, or if data were lacking, we analyzed the results using a rating system with levels of evidence. (24) The rating system consisted of 5 levels of scientific evidence, based on the quality and the outcome of the studies: (1) strong evidence--consistent findings among multiple (2 or more) high-quality RCTs, (2) moderate evidence--consistent findings among 1 high-quality RCT and multiple (2 or more) low-quality RCTs or CCTs, (3) limited evidence--1 low-quality RCT or CCT, (4) conflicting evidence--inconsistent findings among multiple RCTs or CCTs, and (5) no evidence--no RCTs or CCTs found. Findings were regarded as consistent when more than 75% of the studies came to the same conclusion.25

Results

Study Selection

A total of 436 titles and abstracts were found in the literature search. The Cochrane database brought 1 new title and abstract, but the full text of the article was not retrievable (26) (Figure). After eligibility screening, 13 articles (3 RCTs and 10 CCTs) were included in the systematic review, (27-39) including 1 CCT in which the data of the control group were gathered retrospectively. (29)

[FIGURE OMITTED]

Methodological Quality

There was disagreement between the 2 independent reviewers in 12% of the criteria. After the consensus meeting, no disagreement persisted. The quality score varied between 0 and 5 points out of the maximum of 9 points. The results of the methodological assessment are presented in Table 1.

No studies performed a concealed randomization procedure, and only 1 study (33) performed blinded outcome assessment. Therefore, no studies fulfilled the first criterion of high quality (concealed randomization and adequate blinding). Only 2 studies (27,33) achieved a quality score of 5 or higher and, therefore, were considered to be high quality according to the second criterion. The most prevalent shortcomings of the trials were: allocation procedures not randomized and no attempt to mask the outcome assessor.

Study Characteristics

Table 2 presents a short description of the study design, study population, intervention, control group, outcome measures, and quality score for each article included in the systematic review. None of the studies described what was considered idiopathic scoliosis. Only the characteristics of the scoliosis were sometimes described in the inclusion and exclusion criteria of the studies.

The studies showed a wide range of interventions (eg, bracing, electrical surface stimulation, exercises, behavioral treatment). Often, a combination of interventions was compared with another combination of control interventions. In all except 2 studies, (28,32) a brace was part of 1 or both interventions. Four studies (29,33,38,39) evaluated the effect of a brace by comparing it with no treatment, exercises, or electrical stimulation. The effect of training as add-on therapy upon wearing a brace was evaluated in 2 studies. (27,30) Different braces were compared in 5 studies. (31,34-37) In the remaining 2 studies, the effect of behavioral treatment was compared with no treatment (28) and Cotrel traction was compared with exercises. (32) Treatment duration varied enormously between 8 days and 7.8 years, but often the treatment duration is unclear especially in studies of bracing. Optimal duration of treatment is unknown.

The size of the study groups ranged from 4 to 129 subjects. In 9 studies, 1 or more study groups were smaller than 25 patients, indicating an overall low power. The effect of therapy was mostly measured by degrees of change in spinal curvature or Cobb angle. This measure is regarded the best determination of the curve magnitude, which is derived from a standard posteroanterior standing radiograph of the spine7 Other outcome measures were pulmonary function, "rumpfuberhang" (or torso overhang), rotation component of the spine, and loads on instrumented pads. The follow-up period appeared to be short, or there was no follow-up. Only 4 studies (28,34,36,37) had a follow-up period ranging from 4 to 24 months.

One study (29) was ambispective, meaning that the researchers used a retrospective reference group as a control group, while the remainder of this study was prospective. This ambispective study was included as a CCT because full descriptions of the control and intervention groups were given. Both groups were similar at baseline regarding age at onset of treatment and initial spinal curvature. Six studies (29-31,35,37,38) presented success or failure rates or surgery rates, which allowed us to calculate between-group differences.

Analysis

The studies were not considered clinically comparable with regard to interventions, study populations, and treatment duration. Because of this heterogeneity, we refrained from statistical pooling. Using a threshold of 50% of the maximum available score on the Delphi list (5 or more positive items), only 2 studies were considered of acceptable quality. Three subgroups concerning different interventions could be found: braces, exercises, and electrical stimulation. Table 3 presents the results of the included studies.

Bracing

Versus no treatment. In one low-quality study, (38) an underarm plastic brace was compared with no treatment, and the researchers found a significant reduced failure rate in favor of the brace group of approximately 50% to 80%.

As add-on treatment. Concerning the effectiveness of a Milwaukee brace as an add-on treatment to exercises, 1 high-quality study3a showed no additional effect of bracing, but no data were available to be able to calculate RRs. In addition, the mean change of the spinal curvature (pretreatment-posttreatment) in all groups was small (<5[degrees]).

Versus exercises. One low-quality study (29) evaluated the effectiveness of a brace compared with side shift exercises and showed no difference.

Versus electrical stimulation. Two low-quality studies (38,39) compared bracing and electrical stimulation. Nachemson and Peterson (38) found in their low-quality study significant differences in favor of an underarm plastic brace of approximately 40% to 80%, and Schlenzka et al (39) mentioned an 11% difference in favor of the Boston brace but provided no data to calculate RRs.

Comparison of different types of bracing. Five studies, (31,34-37) all of low quality, evaluated the effectiveness of different braces. No data were provided for 1 study, (36) and small changes of the spinal curve were found in both treatment and control groups in another study. (34) In 3 studies, (31,35,36) we were able to calculate RRs and no significant differences were found in favor of a certain brace.

Exercise

One low-quality study (28) evaluated the effectiveness of exercises between subjects who adhered and those who did not adhere to the exercise program ("compliers" versus "noncompliers") and showed a difference of 14 degrees in spinal curvature in favor of behaviorally posture-oriented exercises, but this study had exceptionally low power (control group: n=4).

As add-on treatment. Two studies (27,30) evaluated exercises as add-on treatment to wearing a brace. One high-quality study (27) showed no additional effect of exercises on the spinal curves but did not present data to calculate RRs. In another low-quality study, (30) no difference in surgery rates were found and only small changes in spinal curvature (<5[degrees]) were found in both treatment and control groups.

Versus other interventions. One low-quality study (32) was found that evaluated exercises versus traction during the night. Only small changes in spinal curvature (<5[degrees]) were found in both groups.

Electrical Stimulation

Versus no treatment. When electrical stimulation was compared with no treatment in 1 low-quality study, (38) no difference in effect was found. Failure rates were high (45%-48%) in both treatment and control groups.

As add-on treatment. When electrical stimulation was evaluated as an add-on treatment to exercise therapy in 1 high-quality study, (33) no difference in effect was found; only small changes of the spinal curve were found in both treatment and control groups.

There is limited evidence of the effectiveness of braces when compared with no treatment. In addition, limited evidence was found for the effectiveness of bracing in reducing the spinal curve when compared with electrical stimulation. An additional effect of bracing as an add-on treatment to exercises, of exercises as an add-on treatment to braces, or of electrical stimulation as an add-on treatment to exercise therapy cannot be justified. No difference in effect could be found for electrical stimulation when compared with no treatment, for a brace when compared with exercises, or between different braces.

Sensitivity Analysis

When using only our first criterion of high quality (randomization and masking), no studies were considered to be of high quality. In that case, our conclusion concerning the effectiveness of different braces would not change. Next, we followed a suggestion by Chalmers et al (40) to evaluate different possibilities as "threshold" based on the methodological quality. When using the mean quality score of 2.5 or a median score of 3 as a "threshold," the number of high-quality trials increased to 7. In this case, as well, our conclusions remained unaffected.

Discussion

Overall, no statistical differences between groups could be found, but a large percentage of patients with a decrease of the scoliotic curve were found while wearing a brace when compared with other interventions. The only study that showed statistically significant differences was the study by Nachemson and Peterson, (38) but this study was of low quality and was nonrandomized. In this study, bracing was found to be superior when compared with no treatment or electrical stimulation. In addition, no differences among different braces or between braces and exercises could be found. Therefore, we conclude that the effectiveness of bracing and exercises is not yet established.

This systematic review might have some limitations. Most studies found were of low quality and low power. There was heterogeneity in treatments found, and the duration of treatments and follow-up period also varied enormously.

The methodological quality of the majority of the trials was disappointingly low. We found only 3 RCTs, and the size of the study groups was too small to reach an adequate power. A randomization procedure often was not performed because the researchers considered it unethical to withhold therapy from patients. We do not consider randomization an ethical problem, because the effectiveness of any conservative treatment for adolescent idiopathic scoliosis is not yet proven.

There is difficulty, however, in masking the care provider and the patients during conservative treatment for idiopathic scoliosis. Masking of outcome measurement, especially when measuring Cobb angles, seems to be possible, but was mentioned only once. Using different criteria or cutoff points for quality, our conclusions did not change. Therefore, we regard our conclusions as rather robust.

Most included articles did not mention a follow-up period. A long follow-up period is recommended in order to obtain insights into the long-term effects of treatment, especially bracing. Because of the expected physiological changes, such as developing a poorer body image perception (10-12) or quality of life, (11,13) we believe it is necessary to follow up until maturity.

Most studies did not address the measurement of treatment adherence. It is difficult to estimate teenagers' adherence to orthopedic bracing treatments in the absence of objective measurements of the wearing time, as opposed to the patient's reported value. According to Vandal et al, (41) the adherence rate reported by the participants appeared to be much higher than the actual rate determined by an objective measurement.

The risk of publication and language bias in our review is probably small, because we performed an extensive search and no study was found that could not be included because of language. Some rather well-known studies were excluded because of the design. Most designs were retrospective and did not have a control group, although this was not always clearly stated, such as in the studies by Noonan et al (7) and Fernandez-Feliberti et al. (42) In some studies, such as the studies by Rowe et al (14) and Weiss et al, (43) the results of the intervention group were compared with data from a control group of another study. Most studies claimed beneficial effects of braces or exercises, but controlled studies did not yet clearly confirm these claims.

Cobb angles were used as an outcome measure in all studies except the study by Athanaspoulos et al. (27) In that study, pulmonary function was used as an outcome measure. We do not consider pulmonary function especially relevant for the effect of conservative treatment for idiopathic scoliosis. Pulmonary function is relevant only in patients with thoracic curves over 60 degrees.

None of the studies included quality-of-life outcome measures, although many researchers (11-13) agreed that adolescents with scoliosis who have disturbed perceptions of body image also experience greater problems in their psychological and social development. Quality of life is affected by the presence of and treatment for adolescent idiopathic scoliosis. (11,13) Braces especially, being a physical hindrance, create additional personal insecurity, which further complicates the teenager's identity development. (10,44)

Future research should focus on large, high-quality randomized controlled studies. We believe that it is possible and necessary to conduct a randomized trial evaluating braces and exercises, including an untreated control group with a follow-up until adulthood. We believe that, in future research, outcome measures should include psychological and social effects of different conservative treatments for adolescent idiopathic scoliosis.

Conclusion

The power and methodological quality of the studies were low, and studies were clinically heterogeneous. Therefore, it was impossible to draw firm conclusions regarding the effectiveness of conservative treatments for adolescents with idiopathic scoliosis. We conclude that the effectiveness of bracing and exercises is promising, but not yet established.

References

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(2) Reamy BV, Slakey JB. Adolescent idiopathic scoliosis: review and current concepts. Am Fam Physician. 2001;64:111-116.

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(19) Robinson KA, Dickersin K. Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. Int J Epidemiol. 2002;31:150-153.

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(24) Van Tulder MW, Furlan A, Bombarbier C, Bouter LM; Editorial Board of the Cochrane Collabaration Back Review Group. Updated method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group. Spine. 2003;28:1290-1299.

(25) Smidt N, Assendelft WJ, van der Windt DA, et al. Corticosteroid injections for lateral epicondylitis: a systematic review. Pain. 2002;96: 23-40.

(26) Ferraro C, Masiero S, Venturin A, et al. Effect of exercise therapy on mild idiopathic scoliosis. Europa Medico Physica. 1998;34:25-31.

(27) Athanasopoulos S, Paxinos T, Tsafantakis E, et al. The effect of aerobic training in girls with idiopathic scoliosis. Scand J Med Sci Sports. 1999;9:36-40.

(28) Birbaumer N, Flor H, Cevey B, et al. Behavioral treatment of scoliosis and kyphosis. J Psychosom Res. 1994;38:623-628.

(29) den Boer WA, Anderson PG, van Limbeek J, et al. Treatment of idiopathic scoliosis with side-shift therapy: an initial comparison with a brace treatment historical cohort. Eur Spine J. 1999;8:406-410.

(30) Carman D, Roach JW, Speck G, et al. Role of exercises in the Milwaukee brace treatment of scoliosis. J Pediatr Orthop. 1985;5:65-68.

(31) von Deimling U, Wagner UA, Schmitt O. Long-term effect of brace treatment on spinal decompensation in idiopathic scoliosis: a comparison of Milwaukee brace-Cheneau corset [in German]. Z Orthop Ihre Grenzgeb. 1995;133:270-273.

(32) Dickson RA, Leatherman KD. Cotrel traction, exercises, casting in the treatment of idiopathic scoliosis. Acta Orthop Scand. 1978;49:46-48.

(33) el-Sayyad M, Conine TA. Effect of exercise, bracing, and electrical surface stimulation on idiopathic scoliosis: a preliminary study. Int J Rehabil Res. 1994;17:70-74.

(34) Fiore N, Onimus M, Ferre B, et al. Treatment of lumbar and dorso-lumbar scoliosis using the Boston orthosis and the 3-valve orthosis: comparative study of the results in the frontal and horizontal planes [in French]. Rev Chir Orthop Reparatrice Appar Mot. 1988;74: 569-575.

(35) Gepstein R, Leitner Y, Zohar E, et al. Effectiveness of the Charleston Bending Brace in the treatment of a single curve idiopathic scoliosis. J Pediatr Orthop. 2002;22:84-87.

(36) Minami S. Results of brace treatment in idiopathic scoliosis; evaluation of the patients treated for over two years or those who completed the treatment [in Japanese]. Nippon Seikeigeka Gakkai Zasshi. 1982;56: 471-485.

(37) Mulcahy T, Galante J, DeWald R, et al. A follow-up study of forces acting on the Milwaukee brace on patients undergoing treatment for idiopathic scoliosis. Clin Orthop. 1973;93:53-68.

(38) Nachemson AL, Peterson LE. 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;77:815-822.

(39) Schlenzka D, Ylikoski M, Poussa M. Experiences with lateral electric surface stimulation in the treatment of idiopathic scoliosis [in German]. Beitr Orthop Traumatol. 1990;37:373-378.

(40) Chalmers TC, Smith H, Blackburn B, et al. A method for assessing the quality of a randomised control trial. Control Clin Trials. 1981;2: 31-49.

(41) Vandal S, Rivard CH, Bradet R. Measuring the compliance behavior of adolescents wearing orthopedic braces. Issues Compr Pediatr Nurs. 1999;22(2-3):59-73.

(42) Fernandez-Feliberti R, Flunn J, Ramirez N, et al. Effectiveness of TLSO bracing in the conservative treatment of idiopathic scoliosis. J Pediatr Orthop. 1995;15:176-181.

(43) Weiss HR, Weiss G, Petermann F. Incidence of curvature progression in idiopathic scoliosis patients treated with scoliosis in-patient rehabilitation (SIR): an age and sex-matched controlled study. Pediatr Rehabil. 2003;6:23-30.

(44) Olafsson Y, Saraste H, Ahlgren R. Does bracing affect self-image? A prospective study on 54 patients with adolescent idiopathic scoliosis. Eur Spine J. 1999;8:402-405.

M-LB Lenssinck, PT, BC, is Physiotherapist and Research Assistant, Department of General Practice, Erasmus Medical Centre Rotterdam, Rotterdam, the Netherlands.

AC Frijlink, PT, BC, is Physiotherapist, Department of Physiotherapy, Hogeschool Rotterdam, Rotterdam, the Netherlands.

MY Berger, PhD, MD, is Epidemiologist and Senior Researcher, Department of General Practice, Erasmus Medical Centre Rotterdam.

SMA Bierma-Zeinstra, PT, PhD, is Physiotherapist and Associate Professor, Department of General Practice, Erasmus Medical Centre Rotterdam.

K Verkerk, PT, MSc, is Physiotherapist and Assistant Professor, Department of Physiotherapy, Hogeschool Rotterdam.

AP Verhagen, PT, PhD, is Physiotherapist, Epidemiologist, and Senior Researcher, Department of General Practice, Erasmus Medical Centre Rotterdain, PO Box 1738, 3000 DR Rotterdam, the Netherlands ([e-mail]). Address all correspondence to Dr Verhagen.

Dr Bierma-Zeinstra and Dr Verhagen designed the study. Ms Lenssinck and Ms Frijlink provided data collection and analysis and wrote the draft manuscript. Dr Berger and Ms Verkerk were involved as content experts. Dr Verhagen provided project management and facilities/equipment. All authors critically read the manuscript.

This article was received October 8, 2004, and was accepted April 28, 2005.

Table 1.

Overview of Methodological Quality: Delphi List

                                          Concealed    Baseline
                          Randomization   Allocation   Similarity

Athanasopoulos            Yes             No           Yes
  et al (27)
el-Sayyad and             Yes             DK           Yes
  Conine (33)
den Boer et al (29)       No              No           Yes
Birbaumer et al (28)      No              No           Yes
Carman et al (30)         No              No           Yes
Gepstein et al (35)       No              No           DK
Nachemson and             No              No           DK
  Peterson (38)
Dickson and               Yes             DK           Yes
  Leatherman (32)
von Deimling et al (31)   No              No           DK
Fiore et al (34)          No              No           Yes
Mulcahy et al (37)        No              No           No
Schlenzka et al (39)      No              No           Yes
Minami (36)               No              No           DK

                                        Outcome    Care
                          Eligibility   Assessor   Provider   Patient
                          Criteria      Masked     Masked     Masked

Athanasopoulos            Yes           DK (a)     DK         DK
  et al (27)
el-Sayyad and             Yes           Yes        No         No
  Conine (33)
den Boer et al (29)       Yes           No         No         DK
Birbaumer et al (28)      No            DK         No         No
Carman et al (30)         Yes           DK         DK         DK
Gepstein et al (35)       Yes           DK         DK         DK
Nachemson and             Yes           DK         No         No
  Peterson (38)
Dickson and               No            DK         DK         DK
  Leatherman (32)
von Deimling et al (31)   No            DK         DK         No
Fiore et al (34)          No            No         No         No
Mulcahy et al (37)        DK            No         No         No
Schlenzka et al (39)      No            DK         DK         DK
Minami (36)               No            DK         No         No

                                         Intention-
                          Data           to-Treat     Sum
                          Presentation   Analysis     Score

Athanasopoulos            Yes            Yes            5
  et al (27)
el-Sayyad and             Yes            No             5
  Conine (33)
den Boer et al (29)       Yes            Yes            4
Birbaumer et al (28)      Yes            Yes            3
Carman et al (30)         Yes            No             3
Gepstein et al (35)       Yes            Yes            3
Nachemson and             Yes            Yes            3
  Peterson (38)
Dickson and               No             DK             2
  Leatherman (32)
von Deimling et al (31)   Yes            Yes            2
Fiore et al (34)          No             No             1
Mulcahy et al (37)        Yes            No             1
Schlenzka et al (39)      No             No             1
Minami (36)               No             DK             0

(a) DK="don't know."

Table 2.

Study Characteristics (a)

Study            Design           Study Sample

Athanasopoulos   RCT              Scoliosis: curves
  et al (27)     QS: 5              20[degrees]-50[degrees]
                                  Primary curve in thoracic
                                    region to the right
                                  N=40
                                  Mean age: 13.5 y (I),
                                    13.6 y (C)
                                  Mean curve: 27.4[degrees] (I),
                                    29.5[degrees] (C)
                                  Girls only
el-Sayyad and    RCT              Scoliosis: curves
  Conine (33)    QS: 5              15[degrees]-45[degrees]
                                  N=30
                                  Mean age: 12.1 y (I),
                                    11.8 y (C1),
                                    10.8 y (C2)
den Boer et      CCT,             Scoliosis: Cobb angle
  al (29)          ambispective     20[degrees]-32[degrees]
                 QS: 4            N=164

                                  Mean age: 13.6 y (I, C)
Birbaumer        CCT              Scoliosis: curves
  et al (28)     QS: 3              15[degrees]-38[degrees]
                                  N=19
                                  Mean age: 12.6 y (I),
                                    10.7 y (C)
                                  Mean curve: 25.8[degrees]
Carman et        CCT              Scoliosis: right thoracic,
  al (30)        QS: 3              left lumbar curves of
                                    <60[degrees]
                                  Eligible N=37
                                  Mean age: 13.3 y (I),
                                    12.4 y (C)
                                  Mean curve: 39.0[degrees] (I),
                                    37.0[degrees] (C)
Gepstein et      CCT              Scoliosis: adolescent
  al (35)        QS: 3              type, single curvature
                                  N=122
                                  Age range: 10-16 y
                                  Mean age: 12.8 y (I),
                                    13.0 y (C)
                                  Mean curve: 30.4[degrees]
Nachemson and    CCT              Scoliosis: single curve,
  Peterson       QS: 3              apex between T8 and
  (38)                              L1
                                  N=286
                                  Mean age: 12.6 y
                                  Girls only
Dickson and      RCT              Scoliosis: adolescent onset
  Leatherman     QS: 2            N=20
  (32)                            Mean age: 13.1 y (I),
                                    13.6 y (C)
                                  Mean curve: 42[degrees] (I),
                                    40[degrees] (C)
von Deimling     CCT              Scoliosis: no information
  et al (31)     QS: 2            N=47
                                  Mean curve: 33.3[degrees] (I),
                                    30.5[degrees] (C)
Fiore et al      CCT              Scoliosis: lumbar or
  (34)           QS: 1              thoracolumbar curve
                                  N=30
                                  Mean age: 14.4 y (I),
                                    14.0 y (C)
                                  Mean curve: 30[degrees] (I),
                                    23[degrees] (C)
Mulcahy et       CCT              Scoliosis: no information
  al (37)        QS: 1            N=37
                                  Mean age: 14.5 y (I),
                                    12.7 y (C)
                                  Girls only
Schlenzka et     CCT              Scoliosis: no information
  al (39)        QS: 1            N=40
                                  Mean age: 10.9 y (I),
                                    11.9 y (C)
                                  Mean curve: 26[degrees] (I),
                                    34[degrees] (C)
Minami (36)      CCT              Scoliosis: no information
                 QS: 0            N=509
                                  Mean age: 12.7 y

                                                 Outcome
Study            Intervention                    Measures

Athanasopoulos   I: Boston brace + training,     Pulmonary function
  et al (27)       n=20, mean bracing            Aerobic capacity
                   0.3 y, 2-mo training
                   period, 4 times a week,
                   30 min
                 C: Boston brace, n=20,
                   mean bracing 0.24 y,
                   2-mo measurements
el-Sayyad and    I: exercise program +           Angle of spinal
  Conine (33)      Milwaukee brace, n=8,           curve
                   bracing minimal,
                   18 h/d, 12 wk
                 C1: exercise program,
                   n=10
                 C2: exercise program +
                   electrical stimulation,
                   n=8
                 Exercise program:
                   instruction for daily
                   activity, home exercise,
                   3 times a week physical
                   therapy for 12 wk
den Boer et      I: side shift therapy,          Cobb angle
  al (29)          n=44, mean treatment            (degrees)
                   duration=2.2 y, 10-12
                   times a week, 30 min,
                   follow-up every 4 mo
                 C: brace therapy, n=120,
                   mean treatment
                   duration=3 y, bracing
                   23 h/d
Birbaumer        I: behaviorally posture-        Cobb angle
  et al (28)       oriented training,              (degrees)
                   acoustic signal when
                   patient assumed
                   incorrect posture, n=15,
                   mean wearing
                   time= 15.88 h/d,
                   treatment period=
                   8-39 mo
                 C: Noncompliers, n=4,
                   mean wearing
                   time=4.23 h/d
                   (SD=7.88), treatment
                   period=4-13 mo
Carman et        I: Milwaukee brace +            Spinal curvature
  al (30)          exercises, n=21                 (degrees)
                 C: Milwaukee brace,
                   n=16
                 Bracing for 23 h/d
Gepstein et      I: Charleston bending           Spinal curvature,
  al (35)          brace, n=85, bracing            success rate,
                   at least 8 h at night           surgery rate
                 C: thoraco-lumbo-sacral
                   orthosis, n=37
                 Bracing for 18-22 h/d
Nachemson and    I: underarm plastic brace,      Cobb angle (degrees)
  Peterson         n=111, bracing for at
  (38)             least 16 h/d
                 C1: night-time electrical
                   surface stimulation,
                   n=46
                 C2: no treatment, n=29
                 Treatment duration for all
                   groups until maturity or
                   until failure of treatment
Dickson and      I: traction, n=?, fixed         Spinal curvature
  Leatherman       traction at night, auto-        (degrees)
  (32)             elongation traction during
                   the day, treatment
                   duration=8 d
                 C: exercises, n=?,
                   exercises 2 times a day,
                   1 hr, 20 exercises, 15
                   times, treatment
                   duration=8 d
von Deimling     I: Cheneau corset, n=21,        Cobb angle (degrees)
  et al (31)       mean follow-up=4 y            "Rumpfuberhang"
                 C: Milwaukee brace,
                   n=26, mean follow-
                   up=7.8 y
Fiore et al      I: 3-valve orthosis, n=15,      Spinal curvature
  (34)             mean treatment                  correction, rotation
                   duration=11.1 mo                component (degrees)
                 C: Boston brace, n=15,
                   mean treatment
                   duration=11.8 mo
Mulcahy et       I: Milwaukee brace, throat      Loads on instumented
  al (37)          mold design, n=7                pads (kilograms)
                 C: conventional Milwaukee       Spinal curve (degrees)
                   brace, n=30
Schlenzka et     I: lateral electrical surface   Cobb angle (degrees)
  al (39)          stimulation, n=20, less
                   than 8 h/d, at night,
                   mean treatment
                   duration=1.5 y
                 C: Boston brace, n=20,
                   mean treatment
                   duration=2.2 y
Minami (36)      I: Milwaukee brace              Spinal curvature
                 C: thoraco-lumbo-sacral           (degrees)
                   orthosis, Boston-
                   Milwaukee brace
                 Mean treatment duration for
                   all groups=3.3 y

Study            Details

Athanasopoulos   Scoliosis remained unaffected
  et al (27)       during 2-mo training period
el-Sayyad and    Loss: n=4; 2 (I), 2 (C2)
  Conine (33)
den Boer et      Failure: nonadherence, or
  al (29)          progression Cobb angle
                   >5[degrees] in 4 mo, or
                   progression >10[degrees] during
                   treatment, or Cobb angle
                   >35[degrees]
Birbaumer        Follow-up 4-8 mo
  et al (28)       posttreatment, n=5
Carman et        Loss I: n=6 surgery, n=3
  al (30)          other brace
                 Loss C: n=3 surgery, n=1
                   other brace
Gepstein et      Adherence: 80%
  al (35)        Only complete case analysis,
                   no information on dropouts
Nachemson and    Loss: n=39 (13.6%)
  Peterson       I: n=23
  (38)           C1: n=7
                 C2: n=9
Dickson and
  Leatherman
  (32)
von Deimling     Correlation "rumpfuberhang"
  et al (3l)       and Cobb angle is low
                   ([+ or -] 0.3)
Fiore et al      Follow-up: 12-17 mo
  (34)
Mulcahy et       3 patients changed from
  al (37)          C group to I group
                 Follow-up seems to be 6 mo
Schlenzka et     Loss I: n=5 surgery, n=9
  al (39)          Boston brace
Minami (36)      Follow-up 24 mo posttreatment,
                   n=60, change: -1.6[degrees]

(a) Degrees with "-" sign indicate a decrease of the spinal curvature;
degrees with "+" sign indicate an increase of the spinal curvature.
Failure is >5 degrees progression of spinal curvature. RCT=randomized
controlled trial, CCT=controlled clinical trial, QS=quality score,
I=intervention, C=control.

Table 3.

Results of the Studies Included in Systematic Review (a)

Study                          Intervention

Athanasopoulos et al (27)      I: Boston brace + training, n=20
                               C: Boston brace, n=20
el-Sayyad and Conine (33)      I: exercise + Milwaukee brace,
                                 n=8
                               C1: exercise, n=10
                               C2: exercise + electrical
                                 stimulation, n=8
den Boer et al (29)            I: side shift therapy, n=44
                               C: brace therapy, n=120
Birbaumer et al (28)           I: behaviorally posture-oriented
                                 training, n=15
                               C: noncompliers, n=4
Carman et al (30)              I: Milwaukee brace + exercises,
                                 n=21
                               C: Milwaukee brace: n=16
Gepstein et al (35)            I: Charleston bending brace, n=85
                               C: thoraco-lumbo-sacral orthosis,
                                 n=37
Nachemson and Peterson (38)    I: underarm plastic brace, n=111
                               C1: night-time electrical surface
                                 stimulation, n=46
                               C2: no treatment, n=129
Dickson and Leatherman (32)    I: traction, n=?
                               C: exercises, n=?
von Deimling et al (31)        I: Cheneau corset, n=21
                               C: Milwaukee brace, n=26
Fiore et al (34)               I: 3-valve orthosis, n=15
                               C: Boston brace, n=15
Mulcahy et al (37)             I: Milwaukee brace, throat
                                 mold design, n=7
                               C: conventional Milwaukee brace,
                                 n=30
Schlenzka et al (39)           I: lateral electrical surface
                                 stimulation, n=20
                               C: Boston brace, n=20
Minami (36)                    I: Milwaukee brace
                               C: thoraco-lumbo-sacral orthosis,
                                 Boston-Milwaukee brace

Study                          Results

Athanasopoulos et al (27)      I: increased ability to perform
                                 aerobic work 48.1%
                               C: decreased ability to perform
                                 aerobic work 9.2%
el-Sayyad and Conine (33)      I change: -4.05[degrees]
                               C1 change: -2.93%
                               C2 change: -3.76[degrees]
den Boer et al (29)            I change: +2.6[degrees], failure=34.1%
                               C change: -1.5[degrees], failure=31.7%
Birbaumer et al (28)           I change: -6.14[degrees]
                               C change: +8.20[degrees]
Carman et al (30)              I (n=12) change: -3.7[degrees]
                               C (n=12) change: -3.4[degrees]
Gepstein et al (35)            Success: I=80%, C=81%
                               Surgery: I=12.3%, C=11.8%
                               Failure: I=7.4%, C=5.4%
Nachemson and Peterson (38)    Failure: I=15%, C1 =48%,
                                 C2=45%
Dickson and Leatherman (32)    I change: standing curve in cast
                                 +3[degrees], curve on lateral bending
                                 +1[degrees]
                               C change: standing curve in cast
                                 +1[degrees], curve on lateral bending
                                 -4[degrees]
von Deimling et al (31)        I change: +1.2[degrees], 19% success
                               C change: +2.9[degrees], 3.8% success
Fiore et al (34)               I angle change: -6[degrees]
                               C angle change: -3[degrees]
Mulcahy et al (37)             I: 42.85% remain in brace,
                                 14.3% surgery
                               C: 36.7% remain in brace,
                                 16.7% surgery
Schlenzka et al (39)           I (n=6) change: posttreatment
                                 +5[degrees], follow-up (2.3 y)
                                 +8[degrees]
                               C change: posttreatment -6[degrees],
                               follow-up (2.7 y) -2[degrees]
Minami (36)                    No information about results
                                 of different treatment groups;
                                 results in curve and age groups

Study                          RR as Calculated by the Reviewers
Athanasopoulos et al (27)
el-Sayyad and Conine (33)
den Boer et al (29)            Failure I versus C: RR= 1.08
                                 (0.66-1.75), meaning no differences in
                                 failure rate between I and C
Birbaumer et al (28)
Carman et al (30)              Surgery I versus C: RR=1.52 (0.45-5.18),
                                 meaning no difference in surgery rate
                                 between I and C
Gepstein et al (35)            Surgery I versus C: RR=1.09 (0.36-3.25),
                                 meaning no difference in surgery rate
                                 between I and C
                               Failure I versus C: RR=1.31 (0.28-6.17),
                                 meaning no difference in failure
                                 between I and C
Nachemson and Peterson (38)    Failure I versus C1: RR=0.3 (0.16-0.56),
                                 meaning failure rate in I
                                 significantly lower compared with C1
                               Failure I versus C2: RR=0.28
                                 (0.16-0.48), meaning failure rate in I
                                 significantly lower compared with C2
                               Failure C1 versus C2: RR=0.93
                                 (0.62-1.41), meaning no difference in
                                 failure rate between both control
                                 groups
Dickson and Leatherman (32)
von Deimling et al (31)        Success I versus C: RR=0.84 (0.67-1.05),
                                 meaning no difference in success rate
                                 between I and C
Fiore et al (34)
Mulcahy et al (37)             Surgery I versus C: RR=0.86 (0.12-6.23),
                                 meaning no difference in surgery rate
                                 between I and C
Schlenzka et al (39)
Minami (36)

(a) "Degrees with "-" sign indicate a decrease of the spinal curvature;
degrees with "+" sign indicate an increase of the spinal curvature.
Failure is >5 degrees progression of spinal curvature. RR=relative risk
(95% confidence interval); RR <1 means effect in favor of
first-mentioned comparison. I=intervention, C=control.