A Norwegian study that compared different weaning techniques for patients with scoliosis found planned early weaning of brace use was associated with shortened bracing time and good clinical results.
Researchers followed the long-term progress of the primary major scoliosis curve and surgical rate for patients who underwent unplanned early weaning (aborted brace wear), planned early weaning and ordinary brace wear until skeletal maturity. Among the 381 patients studied, 59 patients underwent planned early weaning, 32 patients underwent unplanned early weaning and 290 patients received ordinary Boston Brace treatment. Long-term results were measured at an average of 23 years after the end of treatment. The researchers also studied sociodemographic and quality of life factors, including self-image and satisfaction with treatment.
All participants were treated between 1976 and 1988 by the now retired Johan Emil Lange, MD. At the time of treatment, Lange was head of the Prosthetic and Orthotic Center at the former Sophies Minde Orthopaedic Hospital in Oslo, Norway, “which at that time served more or less the whole country with respect to treatment for scoliosis,” according to Harald Steen, MD, PhD, a coauthor of the study, research scientist and head of the Biomechanics lab in the Orthopaedic Department at Oslo University Hospital and professor in Clinical Biomechanics at Oslo and Akershus University College of Applied Sciences in Oslo.
An innovative approach
“The idea of planned early weaning was [conceived] and initiated by the innovative Dr. Lange almost 40 years ago in patients who started bracing at a young age with a long [prospective] treatment time, where the original plan was changed before reaching puberty after 2 [years] to 3 years or more of brace treatment,” Steen told O&P News. “Later, influenced by the positive results associated with this new regimen, he also included a few patients with less than 2 years of brace wear.”
All patients chosen for early weaning had to demonstrate a positive impact from the brace with a stable reduction of the primary curve to less than or equal to 25° at repeated measurements. They also had to be skeletally immature, with bone age less than 14 years and Risser grade of 3 or lower at planned early weaning.
Planned early weaning took place gradually by reducing bracing time for 2 hours weekly during a period of 2 months to 3 months. The curve was controlled every 4 months until the end of growth. In contrast, unplanned early weaning occurred for patients who immediately ceased wear of the brace due to personal reasons, most commonly pain, skin irritation and psychological distress.
Physical impact
Among patients who underwent planned early weaning, 48 (81%) had a primary curve less than or equal to 25° at weaning. The mean curve size at the long-term follow-up was 25.1° for patients with planned early weaning, 34° for patients with normal bracing and 34.8° for patients with unplanned early weaning. One patient with planned early weaning (2%) had surgery compared with 14 (5%) of those with ordinary bracing and 12 (38%) of those with unplanned early weaning. Surgery was recommended for patients with curve progression to greater than 45° during bracing and after weaning.
Sixteen patients (27%) with planned early weaning resumed bracing after a mean time of 2 years.
“We were surprised by the finding that the curve did not progress at long-term [follow-up], but this may partly be explained by the fact that those who had progressed at short-term had a new bracing period,” Steen said. “We were also surprised by the result that only one patient [in the planned early weaning group] progressed to about 45° and had surgery.”
The study showed planned early weaning can be effective for patients if the curve reduction is stable with time and the primary curve is reduced to less than or equal to 25°.
“The patients should be monitored carefully and regularly at 4-[month] to 6-month intervals until maturity, and a new brace should be prepared if the curve increases significantly [by greater than 5°],” Steen said.
Steen noted clinical impact should be just as relevant for U.S. practitioners as it is for those in Norway, as both countries follow the treatment protocol established by the Society on Scoliosis Orthopaedic and Rehabilitation Treatment.
Quality of life analysis
The researchers also conducted a long-term assessment of quality of life factors.
“With help from Professor Jens Ivar Brox [MD, PhD], who is an expert in quality of life analysis, we used multiple sociodemographic and quality of life questionnaires to register various parameters,” Steen said.
Questionnaires included measures of pain, disability, quality of life and work, comorbidity, surgery and demographics.
Overall, the differences among groups were small. Quality of life showed most patients are within the average population, although about half of patients had treatment for back problems within the past year.
The planned early weaning group had better results for self-image and satisfaction with treatment, but the differences were small and “of uncertain clinical importance,” according to the study.
Patient selection, recommendations
Steen and colleagues believe planned early weaning was successful for most patients based on patient satisfaction and curve size measurements at long-term follow-up. On average, these patients were saved 2 years of bracing. As patients were selected based on specific criteria, however, those criteria may have influenced the results. All patients with planned early weaning were younger at brace start with smaller curves, better curve flexibility and curve redressement.
The lack of randomization was the main limitation of the study, Steen said.
“In clinical studies in general, and in this old prospective clinical study in particular, stringent selection of patients is hard to accomplish.”
For example, 81% the patients chosen for planned early weaning met the threshold value of a primary curve of less than or equal to 25°.
“Ideally, this recommendation should be based on findings from a future multicenter randomized study comparing planned early weaning and ordinary bracing in patients,” Steen said.
Randomization and a larger study also could provide more clinically important information from the quality of life questionnaires, he added. – by Amanda Alexander
- Reference:
- Steen H, et al. Scoliosis. 2015;doi:10.1186/s13013-015-0059-2.
Disclosures: Steen and his coauthors report no relevant financial disclosures.
