Scoliosis bracing is controversial and will continue to be even though the recently published results of the long awaited trial known as BrAIST concludes that bracing is effective (1). Here’s the overview and a few impressions.
The BrAIST study was conducted at multiple scoliosis clinics across the U.S. and Canada and included 242 participants with adolescent idiopathic scoliosis (AIS) in the 20 – 40º Cobb angle range, Risser sign from 0 – 2, with study patients from 10 to <15 years. Girls could not be more than one year post-menarche.
126 subjects (52%) were in the bracing cohort (wearing a rigid TLSO) and 116 or 48% were observed. Some were assigned randomly to bracing and 71% in the bracing cohort chose their treatment method. Bracing cohort members wore a brace with an imbedded temperature sensor to measure wear time.
The original intent was for BrAIST to be a completely randomized trial, but the importance of choice for families created the need to add a treatment preference option for either bracing or observation.
The measurement of a successful outcome was when a patient reached skeletal maturity – for the purposes of the trial considered to be a Risser 4 for girls (usually 5), or 5 for boys, prior to attaining a 50º Cobb angle when surgery is often recommended.
Both randomized and preferred treatment cohorts yielded fairly consistent results in each category. Conclusions clearly showed bracing to be a more effective option. The braced cohort experienced a 72% success rate, and it was determined the observation only group had a 48% chance of reaching skeletal maturity prior to a 50º Cobb angle.
That standard may be acceptable for a trial, but in my view not at all acceptable in real life. Imagine a theoretical patient in the random cohort. She is diagnosed at eleven years old with a 25º Cobb angle and a Risser of 0. She is prescribed a brace and continues to progress to a Cobb angle of 48º while wearing the brace. At 14 years old it is determined she is a Risser 4. According to trial parameters, this patient experienced a successful outcome while wearing the brace. She exits the study, and may or may not continue to progress until Risser 5.
In consideration of the Lonstein and Carlson progression factor (2) it seems maybe the net was cast a bit wide for the purposes of the trial. One positive was the use of a brace temperature sensor to insure the conclusions were based on compliant patients. Although patients were instructed to wear the brace 18 hours per day, wear time seemed to fall short and the supplement indicated that 27% stopped the brace prior to trial end. This illustrates what a challenge wearing a scoliosis brace can be.
The study does show a correlation between compliance and success and cites 13 hours daily as the threshold to achieve results as high as 90%. The lowest quartile of brace wearers, 0 – 6 hours daily, yielded only a 42% success rate, lower than the observed cohort success threshold. This correlates exactly with what I tell parents and patients, if the patient can’t or won’t be compliant, don’t bother.
The bracing cohort wore the Boston Brace in 68% of instances with the remaining subjects wearing the “Wilmington, or one of several other designs.” When it comes to bracing studies I prefer a breakdown regarding which brace yields which result. Parents take note: this study did not include the well-marketed flexible “dynamic” brace which I don’t recommend (3). I believe the newest and most exciting bracing concepts are out of Germany, are asymmetrical, encourage overcorrection and are Chêneau based (4).
The BrAIST article failed to mention if patients participated in any adjunctive therapies while wearing the brace. I am well aware most spinal surgeons place little value on non surgical treatments for scoliosis, other than bracing, so maybe treatment concurrent to the study was either ignored or disregarded. I mention the omission of the effect of adjunctive therapy for one reason. I instructed a BrAIST participant at our facility during the summer of 2010. She was compliant in wearing her Boston brace, as indicated by its sensor, and also reported compliance practicing her curve pattern scoliosis exercise program at home. Her mother recently reported her curve remained unchanged through skeletal maturity.
Finally, Quality of Life Assessments were reported in the BrAIST study and were consistent between the two groups at 81-82%. Skeptical of QOL questionnaires when it comes to scoliosis, I found it interesting the observed and braced groups were reported to have the same QOL experience. During our scoliosis exercise treatment protocol, I spend hours with adolescent patients and their parents and know the profound impact bracing can have on the patients compared to the patients who come for Schroth and are not braced.
With that said, Pediatric QOL inventory scores cited back pain as the most common adverse “event” for both cohorts and was essentially equivalent. “Events” in both cohorts were considered “related” based on the judgement of the investigator or research coordinator. According to the trial supplement, many in the bracing cohort contended with brace related challenges such as pressure sores on the trunk, anxiety, skin rubbing off at the hip, and headaches while wearing the brace. One braced patient was hospitalized for anxiety and depression, classified as the only “serious” adverse event of the trial. In contrast, the observed cohort experienced “related” adverse events such as hand and feet numbness, hip pain from gymnastics (in my opinion, not recommended with scoliosis) and right heel pain due to a motor vehicle accident.
One of the great frustrations of bracing is that it is difficult for a scoliosis physician to determine who will progress and who will not. Obviously, if we could determine who those kids are we could spare many others unnecessary bracing. Unfortunately, no one has figured that out yet. That fact, and the generally accepted belief that curves held to 30º or less at skeletal maturity are less likely to progress (5) are why an effective proactive approach makes sense.
Our scoliosis treatment program addresses spinal stabilization, specific to each curve pattern. Learning to control scoliosis, early in the diagnosis, improves a patient’s chances of never requiring a brace or surgery.
It is far easier to make an impact on a 20º Cobb angle than a 35º or 40º Cobb angle. We specialize in teaching adolescents what they can do to stop scoliosis from progressing based on the traditional Schroth Method and the newer Scoliologic® techniques. The skills learned help lessen the effects of scoliosis in the near term and are useful over the long term when living life with a spinal curve(s).
Schroth Method principles have helped many kids achieve results which allow them to prevent the need for a scoliosis brace in the first place. However, not everyone is diagnosed with scoliosis at 15º or 20º. For those at high risk or with progressive curves bracing is sometimes a necessary component of curve management.
Whatever the scenario, our objectives are always the same: to keep more kids out of surgery.
1. Weinstein SL, Dolan LA, Wright JG, et al. The Effects of Bracing in Adolescents with Idiopathic Scoliosis. N Engl J Med 2013;Sept 19.
2. Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. Journal of Bone and Joint Surgery 1984; 66-A:1061-1071.
3. Wong MS, Cheng JC, Lam TP, et al. The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis. Spine. 2008; May 20;33(12):1360-5.
4. Weiss HR, Moramarco M. Remodeling of trunk and backshape deformities in patients with scoliosis using standardized asymmetric computer-aided design/computer-aided manufacturing braces. Hard Tissue. 2013;Feb 26;2(2):14.
5. Weinstein SL, Dolan LA, Spratt KF, et al. Health and Function of Patients With Untreated Idiopathic Scoliosis: A 50-Year Natural History Study. JAMA;2003.289(5):559-567.