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Preliminary Results of Part-Time Bracing for the Management of Idiopathic Scoliosis

Christopher J. Roach, BS
Jack T. Andrish, MD

ABSTRACT

We studied 25 patients treated part-time with a Wilmington thoracolumbosacral orthosis in order to determine its efficacy. Our study focused on the outcomes of 19 patients. All were skeletally immature (Risser 0, 1, or 2) at the initiation of orthotic management, with one exception. We followed them until skeletal maturity, until they became non-compliant, or until they required operative intervention. Fifteen of the 19 patients (79%) had curves that did not progress more than 5° during the time interval that the patient was compliant with wearing the orthosis part-time. The remaining four patients (21%) had at least one curve that progressed more than 5° while wearing the orthosis part-time. These results are comparable to those found in the literature for full-time bracing protocols.

Key Words: Idiopathic Scoliosis; Part-Time Bracing.

Introduction

Many factors have been implicated with curve progression in idiopathic scoliosis.^1-6 Most important, larger curves tend to progress more than smaller ones.^1,3,5 Younger and less skeletally mature scoliosis patients are at greater risk for progression. Curves detected prior to menarche have a greater risk of progression. Skeletal maturity can be assessed through the Risser sign. This sign depicts the advancing ossification of the iliac apophysis.^7,8 Double curves tend to progress more than single curves and thoracic curves tend to progress more than lumbar curves.^1,2 Finally, large rib-vertebral angle differences (RVAD) and positive family histories of idiopathic scoliosis are also associated with a heightened risk of curve progression.^2,4,9

A variety of treatment protocols are available to manage idiopathic scoliosis, including exercise programs, electrical stimulation, bracing, and surgical spinal fusion.^10,11 There has been controversy over the effectiveness of orthotic management for idiopathic scoliosis, especially in light of recent results obtained in Iowa City.^12-15 Their study showed no statistical differences between curves managed with an orthosis and their projected natural histories.^1,3,6 However, several previous studies have shown that orthotic treatment can be effective in lowering the percentage of patients who would otherwise require surgery.^10,16-20 Lonstein and Winter studied 1,020 patients treated with the Milwaukee brace and found that significant curve progression or surgical intervention occurred in 40% of skeletally immature patients (Risser 0 or 1) braced with an initial curve of 20-29°, compared with 68% seen in natural history studies.^3,17 The Milwaukee brace was the first consistent orthosis used to treat scoliosis, but compliance with actually wearing the orthosis was low due to the high profile. For this reason, underarm orthoses became popular in the 1970s. In recent years some physicians have prescribed orthoses for part-time use only.^14,21 Part-time bracing with an underarm orthosis can appease patient concerns about appearance and parental concerns with compliance. A study by Green at Vanderbilt University Medical Center showed curve progression in only four of 44 patients who had been managed with a Boston or Milwaukee orthosis part-time.²¹

This retrospective study attempts to determine the effectiveness of a part-time bracing program and to compare these results to historical controls for a full-time schedule. Our present study deals with the Wilmington-type thoracolumbosacral orthosis (TLSO).

Materials and Methods

The Wilmington orthosis is an underarm TLSO made from a cast mold taken from the patient (Figure 1) . Radiographs are used to determine needed pressure points as well as adjustments to the mold, which is then used to fabricate the orthosis.²² This study included patients with idiopathic scoliosis seen at the Cleveland Clinic Foundation between 1980 and 1992 and treated with a protocol using a Wilmington-style orthosis, part-time. Twenty-five patients, consisting of 22 girls and three boys, entered into this treatment plan during this period. Of this original number, adequate information was available on 19 patients (17 girls and two boys). All patients were managed by the same physician (Andrish).

We defined the part-time use of an orthosis as just one aspect of a comprehensive part-time bracing program. Part-time bracing included only the time the patient actually wore the Wilmington TLSO. In contrast, the part-time bracing program began with the part-time use of a Wilmington orthosis and involved conversion to full-time orthotic wear if necessary. Circumstances warranting the conversion to full-time orthotic wear included curve progression, a large curve size from the onset of treatment, parental concern, and non-compliance with part-time orthotic use. Success with the part-time bracing program also included compliance with the physician's guidelines until it was determined that orthotic management was no longer necessary. Those patients whose curves progressed more than 5° while wearing the orthosis part-time were considered failures of part-time bracing, whereas those patients whose curves progressed after part-time bracing was stopped by the physician were failures of the part-time bracing program. For instance, a patient could fail part-time bracing by progressing more than 5° during the time of compliance with bracing, part-time, and eventually succeed in the part-time bracing program through conversion to an effective full-time schedule.

To be recommended for the part-time bracing program, patients had to be diagnosed with idiopathic scoliosis and have a curve between 20° and 40°, or a curve that had progressed 5° or more. In addition, all braced patients had Risser signs of 0, 1, or 2, except for a single patient who was braced because of parental concern and a positive family history. All patients were instructed to wear the orthosis 12-16 hours a day. The normal pattern of wear was after school until the next morning before school.

Information collected from each patient's chart included age at the start of orthotic management, age at the end of bracing, and age at the time of final follow-up. From these values, total time of treatment and total time from the end of treatment to final follow-up were calculated. Next, curve patterns and Cobb angles were recorded. Angles and vertebral rotation were evaluated at the initial visit, at the start of bracing, in the cast mold, in the orthosis, at the end of bracing, and at the final follow-up. The RVAD was measured at the initial visit only. All measurements were done by the same person (Roach) with the exception of two patients whose measurements were taken from chart recordings by Andrish. Since Cobb angle variability reports have ranged from 1.6°²³ to 9.6°,²⁴ previous study guidelines were followed and a progression of 6° or more was considered to be a failure of part-time bracing. Curve progression occurring at any time after part-time bracing was terminated by the physician and was considered to be a failure of the part-time bracing program and not of part-time bracing itself.

Compliance was assessed through either telephone conversations with patients or analysis of chart recordings. Compliance included a combination of how often the patient wore the orthosis, personal feelings toward the orthosis, and recommendations that the patient would give to other scoliosis patients.

Results

Twenty-five patients were available for this study; however, four patients were lost to follow-up and two more stopped wearing the orthosis against medical advice after wearing it for an insignificant amount of time. This left 19 patients available for analysis. Of these nineteen patients, adequate information was present on only eight patients for the part-time bracing program. Ages of the nineteen patients ranged from 5 years, 10 months, to 14 years at the start of treatment and averaged 11 years, 8 months. The average ages at the end of treatment and at the final follow-up were 13 years, 10 months (10-16 years), and 16 years, 9 months (13-21 years), respectively. The total time in the orthosis, part-time, ranged from five to 60 months with an average of 24 months. The average follow-up time from the end of bracing for the eight patients who completed the program was 29 months (5-86 months).

Ten of the 19 analyzed patients had single curves, while nine had double curves. Fifteen of the 28 curves were thoracic with only one being left convex. Six were left lumbar; six were left thoracolumbar; and one was right thoracolumbar. The average curve size at the start of part-time bracing was 26° (16°- 37°) and at the end of part-time bracing it was 24.7° (5°-43°). In patients (N=15) whose curves did not progress more than 5° during part-time use of the orthosis, the average curve size at the end of part-time bracing was 22° (5°-39°) (Table A) . Five of these successful patients had double curves and the other ten had single curves. Six of these patients successfully completed the part-time bracing program (see Figure 2) , five patients subsequently failed the program, and four patients were lost to follow-up.

Of the 19 patients available for study, 15 did not progress during the time period that they were compliant with wearing the orthosis part-time. The remaining four patients all had double curves and at least one in each patient progressed 6° or more. These four patients had an average curve size of 31.6° (21°-43°) at the end of part-time bracing (Table B) . Two of these patients went on to have surgery, one patient had no further treatment, and one patient was lost to follow-up.

Apart from the four patients whose curves progressed while wearing the orthosis part-time, five additional patients failed the part-time bracing program (Table C) . Two of these patients failed because, on their own accord, they stopped wearing their orthosis. Due to poor compliance, they were failures of the program even though neither required further treatment. Another two patients failed the program because their curves progressed after part-time bracing was discontinued by the physician. One required surgery while the other needed no further treatment. The last patient whose curves did not progress more than 5° during part-time bracing was switched to full-time bracing because of the large size of her right thoracic curve (39°) and the observation of a 3° progression. In this instance, conversion to full-time bracing was not effective and she eventually required a spinal fusion (Figure 3) .

Spinal rotation did not change significantly in any of the nineteen patients during treatment, nor was it severe in any patient. The greatest RVAD in any patient was 17° and the average was about 5°. These numbers are not considered significant in calculating risk for curve progression.^9,11

We contacted 14 of the 19 patients by phone to determine compliance and personal feelings about the orthosis. Although patients were instructed to wear the orthosis 12-16 hours each day, the actual time the orthosis was worn each day averaged between 10 and 11 hours and ranged from 8 to 16 hours for the 14 patients contacted. Most patients wore the orthosis less as they grew out of it and the fit became tighter. However, after adjustments were made, orthotic wear usually returned to normal. Two patients mentioned previously were stable during their part-time bracing but failed the program because they became non-compliant and stopped wearing their orthoses.

The 14 patients we contacted also rated orthosis likability, appreciation, and tolerability on an analogue scale from 0 to 10, with 0 being the worst and 10 the best in each category. In terms of how well the orthosis was liked, the average rating was 4.5 and the range was from one to eight. Most patients thought the orthosis was helping them as only three of the 14 patients rated orthosis appreciation below five. The average rating for appreciation was 6.5. Two of the three patients who did not appreciate the orthosis eventually required surgery. Many patients found the orthosis intolerable at first, but became more comfortable with the orthosis a few months into the treatment. The average tolerability score was six and ranged from two to eight. Finally, all 14 patients would recommend treatment with a similar orthosis to other scoliosis patients.

Discussion

Because of the small number of patients captured by our study, and especially by the even smaller number of patients who completed the bracing program, we were unable to assess the efficacy of part-time bracing for the management of idiopathic scoliosis. To make such an assessment would have required a larger number of patients complying with the program who were followed for a much longer period. Our small population did not allow us to categorize our patient cohort by curve size, curve pattern, or patient maturity as similar studies have done. However, one unique aspect of our study was that all of the patients were treated by the same physician using the same type of underarm orthosis. This decreased the opportunity for confounding variables by limiting the treatment method to a single bracing philosophy.

Despite the limitations of this study, our results do show that part-time bracing prevented significant curve progression in 15 out of 19 patients (79%) while they were actively engaged in wearing the orthosis part-time. This is favorable when compared to Lonstein and Carlson's reported 68% probability of curve progression in skeletally immature patients with untreated curves of 20° to 29°.³ Our study is also unique in separating the results of part-time orthosis wear from a part-time bracing program. Our assessment of the ability of the Wilmington orthosis to prevent curves from progressing while wearing the orthosis only part-time is comparable with the reported results of the Wilmington orthosis worn full-time, which reported curve progression of more than 5° at follow-up in 28% of skeletally immature patients with curves measuring 20°-39°.¹⁶

Despite having 15 of 19 patients successfully control their curves while complying with part-time orthosis wear, only six succeeded in the program. This disappointing number was adversely affected by the four patients lost to follow-up. All four had given the appearance that their management would have been successful if they had completed the program. In addition, the two patients who failed the program as a result of non-compliance also had given indications of success.

Finally, there are factors involved with our program that prevent it from being directly compared with others. Many reports on full-time bracing include a weaning process at the end of full-time orthosis wear^15,17 that usually lasts an additional two years. These additional years of orthosis wear could possibly account for additional success with patients in a full-time program. Our study also separates part-time bracing itself from the part-time bracing program. Even though the intent of our part-time bracing program was to salvage those patients who had demonstrated significant curve progression while wearing the orthosis part-time from further curve progression by conversion to full-time orthosis wear, our study had no such successes.

Conclusion

Because of the small number of patients enrolled in our study, and the even smaller number of patients that actually completed the management program, we cannot imply that this was a study of efficacy of a part-time bracing program for the management of idiopathic scoliosis. However, what we do have is a series of patients with scoliosis with curves and maturity levels that most would consider eligible for orthotic management. And, in this cohort, when we looked at how the curve behaved during the period of time that the patient was compliant with the part-time orthotic wear, we found that the percentage of patients in whom the curve did not progress was at least as high as that reported for full-time orthotic regimens. The implication is that in order for an orthosis to be effective in the management of scoliosis in the long term, it must at least demonstrate the ability to control the curve in the short term while the patient is wearing the orthosis. We recognize, however, that overall efficacy is dependent on many additional factors that include compliance, length of time the patient is compliant with a bracing program, weaning, as well as numerous selection criteria in the first place, such as curve size, and skeletal and endocrinologic maturity.

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