Effects of Traditional vs.

Dynamic Bracing on
Scoliotic Curves
Jonathan Davis
Research Methods
Deborah Bubela, PhD, PT, PCS
4/29/2010
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Abstract:

Scoliosis, a three dimensional curvature of the spine has traditionally been managed

conservatively through the use of braces. This study will evaluate the relative effectiveness of the

Boston Brace and SpineCore’ Dynamic scoliosis brace. This will be accomplished through a quasi-

experimental longitudinal repeated measures study. 160 participants will be randomly assigned to

either the Boston Brace or SpineCor’s Dynamic brace. Participants’ Cobb angle and Risser value will be

monitored every 3 months until brace cessation. Then after 5 years biannually until the curve reverts

less than 1 degree per two years. Success of treatment will be assessed through radiographic evaluation

of Cobb angle and stability. Repeated measure ANOVA at .05 alpha will determine if significant

differences exist between braces. This research will serve as a formal comparison to determine whether

dynamic bracing is an effective treatment option, and if so for whom it is most effective.

Introduction:

The Scoliosis Research Society has defined scoliosis as a “lateral deviation of the normal vertical

lines of the spine of greater than 10 degrees or an in-potency, 3-dimensional-form deviation from the

spine, which is accompanied by lateral curvature of the spine with or without a change in the sagittal

and axial surfaces [ CITATION Len05 \l 1033 ]. Adolescent idiopathic scoliosis accounts for the majority

of the scoliosis cases and includes all individuals between the ages of 10 years and skeletal maturity

where the cause of curvature cannot be identified. It is estimated that 2-3% of adolescents have a

curvature of the spine, however only 10% of the diagnosed individuals will need intervention outside of

monitoring the curve for progression. For curves with curvature angles (e.g. Cobb angle) under 10

degrees, the ratio is equal between males and females. Curvatures 30 degrees or greater have been

shown to be 10 times more likely in females then males.

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While treatment for adolescent idiopathic scoliosis occurs worldwide, treatments among

countries are not always consistent. Scoliosis is managed through conservative (non-operative) and

non-conservative (surgical) interventions [ CITATION Wei08 \l 1033 ]. Conservative treatments include

physical therapy and bracing that attempt to halt progression of the curvature. The use of bracing to

prevent curvature progression is controversial with studies both supporting and refuting the use of

orthotics. There are multiple types of orthotics used to manage scoliotic curvature [ CITATION Len05 \l

1033 \m Sch10 \m Row97]. The common ones include the Boston Brace, the Providence Brace, the

Charleston Brace, and a few others. A new player is SpinCor’s dynamic scoliosis bracing system which

uses elastic bands rather than a rigid plastic shell to help realign the spine.

Non-conservative, invasive interventions are reserved for severe scoliotic curvature. Surgical

treatment attempts to achieve four goals: 1) halt progression of the curve; 2) attain maximum

permanent correction for the deformation in all three planes; 3) improve the individuals’ physical

appearance by balancing the trunk; and 4) reduce the likelihood of both short term and long-term

complications.

The Cobb angle typically determines the treatment approach, with angles below 25 degrees

usually being monitored and observed for signs of progression. Physical therapy is often used as a

treatment at this stage in Europe[ CITATION Wei08 \l 1033 ]. As the angle increases to be above 25

degrees but below 45, degrees bracing becomes an option for treatment attempting to push the curve

to a more neutral position to prevent progression until skeletal maturity when the brace can be

removed. Surgical treatment is the preferred option for curves with Cobb angles greater than 45

degrees.

Since ethically one cannot deny medical treatment to individuals, it makes highly controlled

studies of the treatments of adolescent idiopathic scoliosis difficult. The lack of control has been cited
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as a flaw in multiple studies; nevertheless, many consider bracing to be the standard of care for curves

with a high risk of progression [ CITATION Wei08 \l 1033 \m Len05 \m Sch10 \m Gol01]. Given the

various intervention methods, it is important to consider the relationship of brace type and curvature

correction.

The Boston Brace:

The Boston Brace was developed at Boston Children’s Hospital as a low-profile

thoracolumbosacral orthosis (TLSO) as an alternative to larger more cumbersome braces. For example,

the Milwaukee which is a cervicothoracolumbosacral orthosis (CTLSO), has been shown in some studies

to have less compliance then the TLSO’s [ CITATION Fay10 \l 1033 ]. The Boston Brace also served as an

alternative to the Wilmington Brace mainly in the fact that it was not custom molded, but rather built

using prefabricated modules and measurements of the patient to create a custom orthosis rather than

full contact orthosis fabricated from casting. In the nearly 40-year history of the Boston Brace, it has

undergone a variety of changes including removal of the superstructure and the addition of 15 degrees

of lumbar lordosis to aid in derotation of the spine. While compliance has been noted as an issue with

the Boston Brace, it is still one of the most widely used TLSO’s on the market. The Boston Brace has

been shown to be an effective treatment option for curves up to 45 degrees. Compliance with

recommended wear for 18-23 hours per day, is essential in reducing the progression of the curve and

reducing the likelihood of needing a spinal fusion procedure [ CITATION Wil00 \l 1033 ][ CITATION

Kat01 \l 1033 ].

While not indicated in the study by Wiley et al[CITATION Wil00 \n \t \l 1033 ], the study by Katz

and Durrani [CITATION Kat01 \n \t \l 1033 ] differentiated between single and double curves responses

to the Boston Brace [ CITATION Wil00 \l 1033 \m Kat01]. Their research indicated that double curves

were more likely to progress then single curves. They concluded that compliance was a significant factor
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in the likelihood of progression and noted several other studies which arrived at the same conclusion.

They also noted it was important to have a 25% observable correction during in brace x-rays as these

correlated with showing a 73% success rate on these patients with double curves. Individuals showing

in-brace correction of less than 25% only showed a successful treatment outcome 25% of the time.

SpineCor:

SpineCor’s Treatment Protocol identifies indications, contraindications, prescription evaluations,

treatment and wearing protocol [ CITATION The07 \l 1033 ]. The manufacture published guidelines

suggests usage of the device for males or females with diagnosed and confirmed idiopathic scoliosis

greater than 5 years of age, an initial Cobb angle at or above 15 degrees with family history, or

progression of more than 5 degrees in 6-12 months. The Cobb angle must not exceed 50 degrees and

the Risser value must be three or below for curves of all patterns including unusual left thoracic and

right lumbar. Their brace is contraindicated under the following circumstances: neuromuscular scoliosis,

postural scoliosis, patients who have undergone prior treatment other than shoe lifts and physical

therapy, and any individual having a cognitive delay.

Prescription evaluation involves a detailed clinical and neuromuscular examination, along with x-

rays in the erect frontal PA, lateral, and supine AP views to aid in determining Cobb angles, the

reducibility of the curve, and the Risser value [ CITATION The07 \l 1033 ]. The erect PA and lateral view

must include the full thoracolumbar spine and the iliac crest and the supine view should be

“unstretched” showing as much of the T1-S1 segment as possible to fully evaluate the thoracolumbar

spinal for curvature.

The treatment protocol requires 6 visits within the first year following the initial prescription

followed by followup visits every three months until wearing can be ceased. The brace must be worn for

twenty hours a day initially with four one-hour breaks ideally of equal length and equal spacing until the
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following three criteria have been met: obtaining a full Risser value of four or more; reaching 2 years

after puberty or changes in voice; and wearing the brace for a minimum of 18 months. Once these three

criteria have been met an evaluation of whether or not bracing needs to continue should commence.

This procedure involves the patient receiving in and out of brace x-rays looking for a Cobb angle

difference of 5 degrees or less without the brace. If the Cobb angle difference is less than 5 degrees,

bracing will reduce to 10 hours per day for another 6 months otherwise the recommendation will be for

another 6 months of 20 hours per day of wearing. At the 6 months point another x-ray will be taken

with the brace having been removed 72 hours prior to taking the x-ray. If the Cobb angle difference to

the initial wearing x-ray is 5 degrees or less, use of the brace should discontinue. If the difference is

greater than 5 degrees, however, another 6 months of 10 hour daytime wearing will be recommended

at which point another out of brace x-ray will occur and this process will repeat until the difference in

Cobb angle is 5 degrees or less.

Scoliosis has a tendency to revert back to, and in some cases progress past the original curve.

Therefore, long term studies are needed to evaluate the success of treatment using available

techniques. Wiley and Katz [CITATION Wil00 \n \t \l 1033 ] had follow ups ranging from 6.23 years to

13.22 years and an average of 9.7 years and 3 months to 11.5 years averaging 2.7 years respectively

[ CITATION Kat01 \l 1033 \m Wil00]. An additional study investigating the long term success of the

Boston Brace looked at patients between 12 and 28 years, averaging 19.2 years, after removal of the

brace. The study noted all 86 patients who had radiological follow up showed Cobb angles

approximately equal to those which were recorded at their last follow up visit after treatment prior to

being included in this study [ CITATION Lan09 \l 1033 ]. Since the Dynamic SpineCor brace was

developed in 1998 long term research is not available to determine the likelihood of curve progression.

Therefore, it will be impossible to determine if the initial success the device will correspond to long term

sustainable gains or if the curve will need to be treated surgically [ CITATION Fay10 \l 1033 ].
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Three available English studies looked into the success rates of the Dynamic SpineCor brace for

controlling the progression of the scoliosis [CITATION Sur \l 1033 \m Coi03 \m Coi07]. All three of these

studies used inclusion and exclusion criteria consistent with those outlined in the SpineCor’s Treatment

Protocols, but none of them had a follow up greater than 5 years after the orthosis was removed

[ CITATION The07 \l 1033 ]. The 2003 and 2007 studies by Coillard outline percentages of patients who

show improvement or stabilization and progression in their curve. In the 2003 study 93% of patients

showed stabilization or improvements in their curve, and in the 2007 study 95.7% of patients were

stabilized or improved two years after the orthosis had been removed [ CITATION Coi03 \l 1033 \m

Coi07].

Conclusion:

While researchers have questioned the validity of scoliosis research due to the difficulties of

obtaining data controls, numerous studies have shown positive outcomes associated with bracing.

While the research presented in this review has shown more favorable outcomes from the Dynamic

SpineCor brace than the Boston Brace, the available studies showing success for the SpineCor have only

been over a short time frame whereas studies on the success of the Boston Brace have in some cases

averaged almost 20 years. This proposed study will serve as a more formal analysis comparing the

Boston Brace TSLO and the Dynamic SpineCor brace in the management of spinal curvature with strong

controls from the start with the intention of being a long-term study. It research intends on answering

the question, what the most appropriate orthotic device to control spinal curvature to reduce the

number of Scoliosis patients requiring spinal fusion to straighten the curve?

Methods:

Sample Description:
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For participation in the study, patients will need to conform to indications for usage of the

SpineCor dynamic bracing system as outlined by the manufacture [ CITATION The07 \l 1033 ].

Indications for use according to the SpineCor procedures are more restrictive than those for the Boston

Brace, with the lone exception of initial bracing being acceptable in 15-degree curves rather than the 25-

degree standard used for Boston Braces and other traditional bracing options. In an attempt to establish

continuity with other studies, only patients with curves of Cobb angles between 25 and 50 degrees will

be considered. Additionally it a Risser Sign less than or equal 3 is required for participation. Participants

can be of either gender and the number of participants will be 80 for each type of brace. This number is

based on the Wiley et al study titled “Effectiveness of The Boston Brace in Treatment of Large Curves in

Adolescent Idiopathic Scoliosis” which used 50 patients and Lange’s study “Long-term results after

Boston Brace treatment in adolescent idiopathic scoliosis” which had only 64% of patients return for

radiographic follow up. Based on these estimates approximately 51 patients will continue follow up

through the duration of the study from the initial 80 selected for each brace. This procedure will be

used in evaluating both users of SpineCor’s Dynamic brace and the Boston Brace.

Recruitment Techniques:

Individuals will be recruited into the study in a variety of ways. Due to the number of patients

required in the study and the limited access each practice has to scoliosis patients, convenient samplings

from new scoliosis at participating orthotic practices will be used. Additional orthotic providers will be

recruited by sending letters notifying them of the study inviting them to participate. Qualified

individuals must have completed both Boston Brace training as well as SpineCor’s Dynamic brace

training and have experience delivering both types of braces. All qualifying patients will be invited to

participate in the study until the 80 patients in each group have been reached. Parents of children will

elect to participate in the study after reviewing a consent form which summarizes information, risks, and

benefits. Participants will be allowed to opt out of the study at any time they chose and switch braces if
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correction is not being obtained. Additionally participants will be made aware of the study

requirements at the start of the experiment as an attempt to minimize potential dropouts. Both

participation on the part of the patient and parent is required as the patients will initially be under the

age of consent. Parents will sign consent and children will sign assent forms.

Experiment Design:

The experiment will be carried out as outlined on pages 6-10 of the SpineCor protocol, with the

appropriate changes made for the Boston Brace. Each patient will randomly be assigned to either the

SpineCor brace or the Boston Brace. The Boston Braces only requires initial blueprinting, however

followup, weaning, radiographic imagining, and any necessary adjustment will follow up will be as

described in the referenced protocol, and as described in the SpineCor training. Patients in both groups

will use the Cricket thermal sensor to aid in gauging brace wearing compliance. Patients will continue to

return for evaluation after bracing as ceased every two years for a minimum of eight follow up

evaluations to look how the curve is returning to pre brace magnitude.

Data Collection:

Data will be collected at all office visits and every two years after brace cessation. Initial data

collected will include the patient’s initial Cobb angle, Risser value, gender, and if it is a single or double

curve. Every follow up visit will note any adjustments made to either brace, and if the brace is

continuing to provide appropriate in brace and out of brace correction. Values will be recorded for both

in-brace and out of brace angles. Additionally, every two years for a minimum of 16 years the patients

will return for imaging to document the rate at which the curve is progressing, patients will continue

returning for bi annual evaluations until their curve progression slows to less than 1 degree per two

years. They will also be requested come in for two extended follow up visits. The first one will be

dependent on their pre brace magnitude, they will return for evaluation at whatever number of years
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their pre brace curve was at. For example someone with a 37 degree curve would return for evaluation

37 years after bracing ended. Patients will also be requested to return 5 years after that point to assess

final stability of the curve. Statistical analysis will be performed using the repeated measures analysis of

variance will be performed on the data to test performance between the two braces, and how Risser

sign, and curve magnitude impact the results. Curves will be divided into moderate 25-35, and

significant 35-50 for the purposes of analysis. A confidence interval of 0.05 will be used.

Reliability Measures:

Patient compliance will be recorded by the patient, parent, as well as the cricket thermal sensor.

Certified and experienced radiographers will be responsible for taking the x-rays and measuring the

Cobb angles. Certified orthotists with additional certifications in use of the Boston Brace and SpineCor’s

Dynamic bracing will be used to measure and fit the orthosis.

Limitations:

The main limitation of this study is patient compliance, and willingness of patients to return for

continued evaluation. These will be mitigated by patient education and awareness of the importance.

Additionally regular reminders will be sent to the patient reminding them they have a scheduled office

visit.

Conclusion:

Through the study, analysis will continuously take place looking for differences between the

success rates of both braces investigating if either brace has a greater success in small or large curves, or

single or double curves. Since both braces are considered full time braces compliance differences

between the two are expected to be negligible. However since the Boston Brace is easier to apply
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correctly due to its less complex strapping system it is expected that the simplicity and rigid shell will

produce more favorable results.

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141-148.

Coillard, C., Vachon, V., Circo, A. B., Beausejour, M., & Rivard, C. H. (2007). Effectiveness of the SpineCor
Brace Based on the New Standardized Criteria Proposed by the Scoliosis Research Society for
Adolescent Idiopathic Scoliosis. Journal of Pediatric Orthopedics, 27(4), 375-379.

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The SpineCorperation. (2007, March). Home Page - SpineCor. Retrieved February 12, 2010, from The
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Weiss, H. R., & Goodall, D. (2008). The treatment of adolescent idiopathic scoliosis (AIS) according to the
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