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The Journal of Bone and Joint Surgery 78:1056-62 (1996)
© 1996 The Journal of Bone and Joint Surgery, Inc.

Adolescent Idiopathic Scoliosis: Treatment with the Wilmington Brace. A Comparison of Full-Time and Part-Time Use*

NANNI J. ALLINGTON, M.D.{dagger} and J. RICHARD BOWEN, M.D.{ddagger}, WILMINGTON, DELAWARE

Investigation performed at the Alfred I. duPont Institute, Wilmington


    Abstract
 Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 
We reviewed the clinical records and the radiographs of 188 patients who had adolescent idiopathic scoliosis. Our purpose was to determine whether part-time and full-time bracing had been equally effective in preventing progression of the curve. Full-time bracing had been used for ninety-eight patients; part-time bracing, for forty-nine; and electrical stimulation, for forty-one. Eighty-eight patients had had a curve of less than 30 degrees and 100 patients, a curve of 30 to 40 degrees. The treatment was considered a failure if the curve had increased 5 degrees or more. The curve progressed 5 degrees or more in thirteen (36 per cent) of the thirty-six patients who had had full-time bracing for a curve of less than 30 degrees, in thirteen (41 per cent) of the thirty-two who had had part-time bracing for such a curve, and in fourteen (70 per cent) of the twenty who had had electrical stimulation for such a curve. Compared with electrical stimulation, both full-time and part-time bracing prevented progression significantly more effectively (p < 0.02 and p < 0.04, respectively). With the numbers available, the difference in progression between the groups that had had full-time and part-time bracing was not significant (p < 0.18). The curve progressed 5 degrees or more in thirty-six (58 per cent) of the sixty-two patients who had had full-time bracing for a curve of 30 to 40 degrees, in ten of the seventeen who had had part-time bracing for such a curve, and in eighteen (86 per cent) of the twenty-one who had had electrical stimulation for such a curve. The difference in progression between each bracing program and electrical stimulation was significant (p < 0.03 for the full-time program and p < 0.05 for the part-time program). With the numbers available, the difference in progression between full-time and part-time bracing was not significant (p < 1.14).


    Introduction
 Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Historically, full-time use of the Milwaukee brace has been reported to be effective in altering the natural history of adolescent idiopathic scoliosis1,8,10,13,26,29,30. During the last few decades, less cumbersome thoracolumbosacral orthoses have been developed; however, the data regarding their effectiveness are conflicting. Emans et al., Bunnell et al.6, and Bassett et al. reported control of progression with use of underarm braces, whereas Miller et al. were less enthusiastic. Green reported that part-time use of underarm braces was effective. However, these studies included different types of curves and varying durations of follow-up, making it difficult to use the data for the purpose of comparison.

In the current study, we compared the effectiveness of full-time and part-time use of the Wilmington brace in the treatment of adolescent idiopathic scoliosis. The results of bracing were also compared with those obtained with electrical stimulation21.


    Materials and Methods
 Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Between March 1983 and April 1985, 349 patients who had adolescent idiopathic scoliosis were managed with a brace or electrical stimulation at the Alfred I. duPont Institute. The criteria for inclusion in the present study were an age of at least nine years at the time of the initial diagnosis; skeletal immaturity (a Risser sign of 0 or 1); a curve of 40 degrees or less, with the apex caudad to the seventh thoracic vertebra; compliance with the treatment program; and follow-up until maturity. On the basis of these criteria, 188 patients were included in the study: ninety-eight (ninety-one girls and seven boys) who had used a brace full-time, forty-nine (forty-five girls and four boys) who had used a brace part-time, and forty-one (thirty-six girls and five boys) who had received electrical stimulation.

The patients were divided into two groups on the basis of the magnitude of the curve at the beginning of treatment. Of eighty-eight patients who had a curve of less than 30 degrees, thirty-six had full-time bracing, thirty-two had part-time bracing, and twenty had electrical stimulation. One hundred patients had a curve of 30 to 40 degrees: sixty-two had full-time bracing, seventeen had part-time bracing, and twenty-one had electrical stimulation.

Patients in the full-time program wore the brace twenty-three of twenty-four hours a day. Weaning, which took a mean of one year, began when the girls had a Risser sign of 4 and were two years postmenarche and when the boys had a Risser sign of 5. Part-time bracing consisted of wearing the brace twelve to sixteen hours a day until maturity, as defined for the full-time group. The electrical stimulation was applied with a single or dual-photon electrospinal orthosis (Medtronic, Minneapolis, Minnesota) that was worn at night21.

The Cobb method7,9,18 was used to measure the magnitude of the curve on radiographs that were made at the time of initial presentation, at the initiation of treatment, when the first cast mold was applied, when the first brace was fitted, at the start of weaning, when treatment was discontinued, at the latest follow-up visit, and before operative intervention. The durations of the bracing, weaning, electrical stimulation, and follow-up were noted, as was the number of braces that had been used. Failure of non-operative treatment to halt the progression of the curve was defined as an increase in the Cobb angle of 5 degrees or more.

The results of full-time and part-time use of the brace were compared with each other as well as with the results of electrical stimulation for both groups of curves14. Chi-square analysis was used to assess the significance of gender and the degree of skeletal maturity (as determined by the presence or absence of menarche and by the Risser sign), and one-way analysis of variance was used to evaluate the influence of the magnitude of the curve. Both tests were used to analyze the results of the three treatment programs.

Curves of Less Than 30 Degrees
The curves of less than 30 degrees included sixty-nine single curves (thirty-three thoracic, twenty-four thoracolumbar, and twelve lumbar curves) and nineteen double-major curves (eight thoracic-thoracolumbar and eleven thoracic-lumbar curves).

The mean curve at the time of the initial presentation was 22 degrees (range, 10 to 29 degrees) in the group that was to be managed with full-time bracing, 21 degrees (range, 9 to 28 degrees) in the group that was to be managed with part-time bracing, and 23 degrees (range, 17 to 29 degrees) in the group that was to receive electrical stimulation. At the beginning of treatment, the mean curves were 25 degrees (range, 20 to 29 degrees), 24 degrees (range, 20 to 28 degrees), and 25 degrees (range, 20 to 29 degrees), respectively. After the application of the first cast mold, the mean curve was 9 degrees (mean correction, 64 per cent [range, 23 to 92 per cent]) in the group that was to be managed with full-time bracing and 9 degrees (mean correction, 63 per cent [range, 52 to 100 per cent]) in the group that was to be managed with part-time bracing. After the application of the first brace, the mean curve was 12 degrees (mean correction, 52 per cent [range, 25 to 80 per cent]) in the group that was to be managed with full-time bracing and 13 degrees (mean correction, 46 per cent [range, 8 to 100 per cent]) in the group that was to be managed with part-time bracing. At the start of weaning, the mean curve was 24 degrees (range, 10 to 42 degrees) in the group that had had full-time bracing. At the end of treatment, the mean curve was 26 degrees (range, 8 to 47 degrees) after full-time bracing, 28 degrees (range, 10 to 50 degrees) after part-time bracing, and 29 degrees (range, 19 to 63 degrees) after electrical stimulation. At the latest follow-up visit, the mean curve was 28 degrees (range, 15 to 47 degrees) in the group that had had full-time bracing, 28 degrees (range, 15 to 59 degrees) in the group that had had part-time bracing, and 35 degrees (range, 20 to 63 degrees) in the group that had had electrical stimulation (Table I).


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TABLE I DATA ON THE EIGHTY-EIGHT PATIENTS WHO HAD A CURVE OF LESS THAN THIRTY DEGREES

 
The mean duration of treatment (including the one-year period of weaning) was three years for full-time bracing, two years and five months for part-time bracing, and two years and two months for electrical stimulation. All patients were followed until full maturity. The patients were followed for a mean of one year and four months after the completion of full-time bracing, one year and two months after the completion of part-time bracing, and two years and two months after the completion of electrical stimulation. A mean of three braces were used full-time, and a mean of two braces were used part-time.

Curves of 30 to 40 Degrees
The curves that measured 30 to 40 degrees included sixty single curves (forty thoracic, fifteen thoracolumbar, and five lumbar curves), thirty-nine double-major curves (twenty-three thoracic-thoracolumbar and sixteen thoracic-lumbar curves), and one multiple curve.

The mean curve at the time of the initial presentation was 33 degrees (range, 30 to 40 degrees) in the group that was to be managed with full-time bracing, 31 degrees (range, 30 to 40 degrees) in the group that was to be managed with part-time bracing, and 32 degrees (range, 30 to 40 degrees) in the group that was to receive electrical stimulation. At the beginning of treatment, the mean curves were 35 degrees (range, 30 to 40 degrees), 34 degrees (range, 30 to 40 degrees), and 33 degrees (range, 30 to 40 degrees), respectively. After the application of the first cast mold, the mean curve was 17 degrees (mean correction, 51 per cent [range, 23 to 83 per cent]) before full-time bracing and 13 degrees (mean correction, 62 per cent [range, 30 to 84 per cent]) before part-time bracing. After the application of the first brace, the mean curve was 21 degrees (mean correction, 40 per cent [range, 0 to 82 per cent]) in the group managed full-time and 18 degrees (mean correction, 47 per cent [range, 10 to 82 per cent]) in the group managed part-time. The mean curve was 36 degrees (range, 20 to 58 degrees) at the time of weaning from full-time bracing. At the end of treatment, the mean curve was 39 degrees (range, 26 to 58 degrees) in the group that had had full-time bracing, 34 degrees (range, 30 to 60 degrees) in the group that had had part-time bracing, and 42 degrees (range, 32 to 63 degrees) in the group that had had electrical stimulation. The mean curves at the time of the latest follow-up visit were 41 degrees (range, 28 to 58 degrees), 41 degrees (range, 30 to 62 degrees), and 43 degrees (range, 32 to 63 degrees), respectively (Table II).


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TABLE II DATA ON THE ONE HUNDRED PATIENTS WHO HAD A CURVE OF THIRTY TO FORTY DEGREES

 
The mean duration of treatment (including the one-year weaning period) was three years and one month for full-time bracing, two years and seven months for part-time bracing, and two years and two months for electrical stimulation. All patients were followed until maturity. The mean duration of follow-up was two years and one month after the completion of full-time bracing, one year and four months after part-time bracing, and one year and six months after electrical stimulation. A mean of three braces were used full-time, and a mean of two braces were used part-time.


    Results
 Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Chi-square analysis showed no significant demographic differences among the patients in the three treatment groups (p < 0.62 for gender, p < 0.97 for the Risser sign, and p < 0.54 for menarche). This made it possible to compare the three groups of patients. One-way analysis of variance applied to the two groups of curves showed no significant differences (p < 0.09 for curves of less than 30 degrees and p < 0.12 for curves of 30 to 40 degrees).

Curves of Less Than 30 Degrees
The curve progressed 5 degrees or more in thirteen (36 per cent) of the thirty-six patients who had had full-time bracing, thirteen (41 per cent) of the thirty-two who had had part-time bracing, and fourteen (70 per cent) of the twenty who had had electrical stimulation (Fig. 1-A). The differences in the percentage of patients who had progression, between the two groups that had had bracing and the group that had had electrical stimulation, were significant (p < 0.02 for full-time bracing compared with electrical stimulation, p < 0.04 for part-time bracing compared with electrical stimulation, and p < 0.05 for both bracing groups compared with electrical stimulation; chi-square analysis). With the numbers available, the difference in progression between the groups that had had full-time and part-time bracing was not significant (p < 0.18).



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Figs. 1-A and 1-B: Graphs showing the mean curves at the initiation of treatment and at the latest follow-up evaluation. Fig. 1-A: Curves of less than 30 degrees at the initiation of treatment.

 
Operative intervention was recommended for two (6 per cent) of the thirty-six patients who had had full-time bracing, two (6 per cent) of the thirty-two who had had part-time bracing, and three (15 per cent) of the twenty who had had electrical stimulation. Of these patients, one in each group that had had bracing and two who had had electrical stimulation had operative intervention.

Curves of 30 to 40 Degrees
The curve progressed 5 degrees or more in thirty-six (58 per cent) of the sixty-two patients who had had full-time bracing, ten of the seventeen who had had part-time bracing, and eighteen (86 per cent) of the twenty-one who had had electrical stimulation (Fig. 1-B). The difference, in the percentage of patients who had progression, between each group that had had bracing and the group that had had electrical stimulation was significant (p < 0.03 for full-time bracing compared with electrical stimulation and p < 0.05 for part-time bracing compared with electrical stimulation). With the numbers available, the difference in progression between the two groups that had had bracing was not significant (p < 1.14).



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Fig. 1-B Curves of 30 to 40 degrees at the initiation of treatment.

 
An operation was recommended for thirty-five (56 per cent) of the sixty-two patients who had had full-time bracing, six of the seventeen who had had part-time bracing, and fourteen (67 per cent) of the twenty-one who had had electrical stimulation, and an operation was performed in twenty, four, and five patients, respectively. With the numbers available, one-way analysis of variance showed that, in the group of patients who had operative treatment, the difference in the prevalence of curve progression among the treatment programs was not significant (p < 0.74). This finding may be secondary to the posterior spinal arthrodesis, which altered the progression and, therefore, decreased the magnitude of the curve at the most recent follow-up visit (Table II).


    Discussion
 Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 
The effectiveness of any non-operative treatment of adolescent idiopathic scoliosis must be compared with the natural course of the disease. Unfortunately, few investigations have met the criteria for a study of the natural history of scoliosis. We were able to assess our results, in patients who had had a curve of less than 30 degrees, in relation to the results reported by Lonstein and Carlson, who reviewed the natural history of the disease in 727 patients. Lonstein and Carlson found that 192 (68 per cent) of skeletally immature patients (a Risser sign of 0 or 1) who had had a curve of 20 to 29 degrees had curve progression of 5 degrees or more. Those findings supported the conclusion of Rogala et al., who reported progression of the curve in forty-one (79 per cent) of fifty-two skeletally immature patients who had had a curve of between 20 and 30 degrees. Bunnell5 reported progression of the curve in 52 per cent of patients who had had a curve of between 20 and 30 degrees.

It is difficult to find any studies on the natural history of scoliotic curves of 30 degrees or more in skeletally immature patients. New studies on natural history are unlikely to become available because, as a result of the greater degree of awareness and screening programs, patients are referred sooner for treatment and observation of a progressive curve is socially unacceptable. Picault et al. reported progression of the curve in five of eight patients who had had a curve of between 30 and 39 degrees. Bunnell4 stated that 67 per cent of curves of 30 to 40 degrees progressed. Nachemson et al.20 reported that 90 per cent of curves of between 30 and 60 degrees progressed in children who were ten to twelve years old. In the current study, electrical stimulation did not prevent progression (of 5 degrees or more) of fourteen (70 per cent) of twenty curves that were less than 30 degrees or of eighteen (86 per cent) of twenty-one curves that were 30 to 40 degrees; therefore, we used this group as a control for the purpose of evaluating the results of bracing. We are aware that curves may progress after maturity2,22,26-28; however, we did not analyze progression after maturity. Instead, we focused on the effectiveness of treatment with a brace during the rapid growth period of adolescence, with sufficient follow-up to allow the curve to settle after complete cessation of use of the brace.

The criteria for the effectiveness of braces have varied among authors. Bassett et al., Emans et al., and Green defined progression as an increase of more than 5 degrees irrespective of the magnitude of the curve. This is slightly different from the criteria of Lonstein and Carlson. Bassett et al. observed progression of twenty-seven (28 per cent) of ninety-five curves that were 20 to 39 degrees and suggested that failure of the brace to halt progression does not automatically imply a poor clinical result, as only a small percentage of the curves that progressed necessitated operative intervention.

Montgomery et al. defined failure of the brace as progression of the curve to more than 45 degrees and a possible need for operative treatment; they reported failure in forty-nine (21 per cent) of 233 patients. In the current study, we reported both progression of 5 degrees or more and progression leading to a recommendation for or actual operative intervention. The effectiveness of the brace was judged on the basis of its ability to prevent progression of 5 degrees or more at the latest follow-up visit as compared with the initial curve. We agree with Lonstein and Carlson that full-time bracing effectively prevents progression. In addition, we found that only a small number of patients who had a curve of less than 30 degrees needed operative treatment (Table I), compared with a larger number who had a curve of 30 to 40 degrees (Table II).

The curves at the initiation of treatment have been grouped differently in the various published studies, making comparison difficult. Bassett et al. included curves of 20 to 39 degrees in one group, Montgomery et al. included all curves of 45 degrees or less, Emans et al. described several groups with curves ranging from 20 to 59 degrees, Miller et al. included curves of 15 to 30 degrees, Green included curves of at least 25 degrees, and O'Donnell et al. divided the curves into two groups (20 to 29 degrees and 30 to 39 degrees). In the current study, we identified a group of patients who had a curve of less than 30 degrees, to match the group of curves of 20 to 29 degrees in the study of natural history by Lonstein and Carlson. O'Donnell et al. reported that, after electrical stimulation, there was progression of forty-six (71 per cent) of sixty-five curves that had measured 20 to 29 degrees and nineteen (66 per cent) of twenty-nine curves that had measured 30 to 39 degrees. Similar to O'Donnell et al., we did not find electrical stimulation to be effective.

Several authors have analyzed the results of bracing according to the pattern of the curve. Emans et al. noted that the pattern of the curve did not seem to alter the effectiveness of the brace. Nachemson and Peterson, in a prospective study, included all curves with an apex between the eighth thoracic and first lumbar vertebrae. We did not analyze the results according to the pattern of the curve, but we noted that the apex was between the eighth thoracic and first lumbar vertebrae in 158 of our 188 patients. The numbers of patients are too small for further division, and any statistical analysis of such data would be meaningless.

The types of scoliosis have differed among published studies, making it even more difficult to compare the results. Emans et al. included all patients between four and eighteen years old who had idiopathic scoliosis; Miller et al., all patients between eight and seventeen years old; McCollough et al., patients who had congenital and neuromuscular scoliosis; and Montgomery et al., girls less than sixteen years old and boys less than seventeen years old. All of those authors concluded that full-time bracing was effective, but the data are difficult to analyze because of differences in the patient populations. For this reason, we compared our data with those in the natural history group in the study by Lonstein and Carlson, those in the group that had had electrical stimulation in the study by O'Donnell et al., and those in our group that had had electrical stimulation, as these three populations can be matched most closely.

On the basis of a difference between the results for patients who had not complied with a bracing program and the results for those who had complied part-time, Emans et al. suggested that part-time bracing may be as effective as full-time bracing. Green performed a prospective study of the effects of part-time bracing and concluded it to be effective, but his sample of patients was small and there were no control groups.

We found that full-time and part-time bracing were equally effective in preventing progression of curves of 40 degrees or less in skeletally immature patients who had adolescent idiopathic scoliosis.


    Footnotes
 

*No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. No funds were received in support of this study.

{dagger}Centre Hospitalier Regional de la Citadelle, Boulevard du 12 sup e de Ligne, 1, 4000 Liege, France.

{ddagger}Alfred I. duPont Institute, P.O. Box 269, Wilmington, Delaware 19899.


    References
 Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

  1. Andrews, G., and |and |MacEwen, G. D.: Idiopathic scoliosis. An 11-year follow-up study of the role of the Milwaukee brace in curve control and trunco-pelvic alignment. Orthopedics, 12: 809-816, 1989.[Medline]
  2. Ascani, E.; Bartolozzi, P.; Logroscino, C. A.; Marchetti, P. G.; Ponte, A.; Savini, R.; Travaglini, F.; Binazzi, R.; and |and |Di Silvestre, M.: Natural history of untreated idiopathic scoliosis after skeletal maturity. Spine, 11: 784-789, 1986.[Medline]
  3. Bassett, G. S.; Bunnell, W. P.; and |and |MacEwen, G. D.: Treatment of idiopathic scoliosis with the Wilmington brace. Results in patients with a twenty to thirty-nine-degree curve. J. Bone and Joint Surg., 68-A: 602-605, April 1986.[Abstract/Free Full Text]
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  6. Bunnell, W. P.; MacEwen, G. D.; and |and |Jayakumar, S.: The use of plastic jackets in the non-operative treatment of idiopathic scoliosis. Preliminary report. J. Bone and Joint Surg., 62-A: 31-38, Jan. 1980.[Abstract/Free Full Text]
  7. Carman, D. L.; Browne, R. H.; and |and |Birch, J. G.: Measurement of scoliosis and kyphosis radiographs. Intraobserver and interobserver variation. J. Bone and Joint Surg., 72-A: 328-333, March 1990.[Abstract/Free Full Text]
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