11.08.13
Back braces may not be the most aesthetically pleasing invention, but they certainly can be effective treatment devices.
New research indicates bracing helps decrease the progression of curves in adolescent patients with idiopathic scoliosis.In a prospective, partly randomized study, bracing led to treatment success in 72 percent of patients, compared with 48 percent of those who simply were observed over time, according to Stuart Weinstein, M.D., of the University of Iowa in Iowa City.
Treatment success significantly was associated with the amount of time patients wore their braces on a daily basis, Weinstein and colleagues reported online in The New England Journal of Medicine and at the annual meeting of the Scoliosis Research Society in Lyon, France. In the lowest quartile of wear time - less than six hours a day - the rate of treatment success was 41 percent, compared with between 90 percent and 93 percent in the top two quartiles, defined as more than 12.9 hours a day.
The multicenter study of 242 patients, ages 10 to 15, was stopped early because of the efficacy of bracing, the researchers reported.
Bracing is one of many available treatments, but there's really no specific marker that helps doctors and patients decide on the appropriate therapy, noted William Taylor, M.D., of the University of California San Diego in La Jolla.
"Scoliosis comes as a range of diseases, of pathophysiology, and of treatments," he told MedPage Today, adding that the study will "allow us to give patients and families higher-quality information."
"I don't know if it's going to change practice," Taylor said, "but what it certainly does is change the discussion and change the information you have to give to patients about what some of the treatments are and also what some of the failures are."
Earlier research also has suggested that in some patients, bracing can improve outcomes, Weinstein and colleagues reported, though most studies have been observational and results have been inconsistent.
"The effect of bracing on curve progression and rate of surgery has remained unclear," they noted. To help fill the gap, they designed a randomized trial, but slow enrollment led them to add a preference cohort in which patients and families could choose their therapy.
Patients were eligible if they had "typical indications for bracing" because of age, skeletal immaturity, and degree of scoliosis. The primary outcomes were treatment failure, defined as a curve progression to a Cobb angle of 50 degrees or more, and treatment success, defined as skeletal maturity with less curve progression.
A total of 1,086 patients met the inclusion criteria and 383 agreed to partipate in the study, but 141 were not analyzed because they had not reached the endpoint when the study was stopped.
Of the 242 patients in the analysis, 116 were in the randomized arm, including 51 assigned to receive a brace and 65 assigned to observation. Among the remaining 126 patients in the preference cohort, 88 chose a brace and 38 chose observation.
When both cohorts were analyzed together, the rate of treatment success was 72 percent after bracing and 48 percent after observation, yielding a propensity-score-adjusted odds ratio (OR) for treatment success of 1.93 (95 percent CI 1.08-3.46).
With the analysis restricted to the randomized cohort, the rate of treatment success was 75 percent among patients assigned to bracing and 42 percent among those assigned to observation (unadjusted OR 4.11, 95 percent CI 1.85-9.16), Weinstein and colleagues reported.
Most patients were fitted with a brace that recorded temperature and time as a means of quantifying the amount of time it was worn, the investigators noted.
During the first six months, they found, patients wore the brace for an average 12.1 hours a day, ranging from none to 23 hours.
While the study adds the "weight of the literature" in favor of bracing, Taylor noted that the patients might have been self-selected to have success, since about 65 percent of those screened and eligible did not take part in the study.
Indeed, the enrolment difficulties "must be considered in interpreting the results," commented Eugene Carragee, M.D., of Stanford University School of Medicine in Stanford, Calif., and Ronald Lehman, M.D., of the Walter Reed National Military Medical Center in Bethesda, Md.
In an accompanying editorial, they said that the associations between braces and treatment success might have been "inadvertently magnified" if participants whose curves were more likely to progress were less inclined to wear a brace -- something might have happened, for instance, if a patient had a relatively stiff curve that resisted the pressure of the brace.
Since the study also showed that some children did well without a brace, they concluded that "the challenge for the field going forward is to identify children who are most likely to benefit from bracing and those who are unlikely to benefit."
New research indicates bracing helps decrease the progression of curves in adolescent patients with idiopathic scoliosis.In a prospective, partly randomized study, bracing led to treatment success in 72 percent of patients, compared with 48 percent of those who simply were observed over time, according to Stuart Weinstein, M.D., of the University of Iowa in Iowa City.
Treatment success significantly was associated with the amount of time patients wore their braces on a daily basis, Weinstein and colleagues reported online in The New England Journal of Medicine and at the annual meeting of the Scoliosis Research Society in Lyon, France. In the lowest quartile of wear time - less than six hours a day - the rate of treatment success was 41 percent, compared with between 90 percent and 93 percent in the top two quartiles, defined as more than 12.9 hours a day.
The multicenter study of 242 patients, ages 10 to 15, was stopped early because of the efficacy of bracing, the researchers reported.
Bracing is one of many available treatments, but there's really no specific marker that helps doctors and patients decide on the appropriate therapy, noted William Taylor, M.D., of the University of California San Diego in La Jolla.
"Scoliosis comes as a range of diseases, of pathophysiology, and of treatments," he told MedPage Today, adding that the study will "allow us to give patients and families higher-quality information."
"I don't know if it's going to change practice," Taylor said, "but what it certainly does is change the discussion and change the information you have to give to patients about what some of the treatments are and also what some of the failures are."
Earlier research also has suggested that in some patients, bracing can improve outcomes, Weinstein and colleagues reported, though most studies have been observational and results have been inconsistent.
"The effect of bracing on curve progression and rate of surgery has remained unclear," they noted. To help fill the gap, they designed a randomized trial, but slow enrollment led them to add a preference cohort in which patients and families could choose their therapy.
Patients were eligible if they had "typical indications for bracing" because of age, skeletal immaturity, and degree of scoliosis. The primary outcomes were treatment failure, defined as a curve progression to a Cobb angle of 50 degrees or more, and treatment success, defined as skeletal maturity with less curve progression.
A total of 1,086 patients met the inclusion criteria and 383 agreed to partipate in the study, but 141 were not analyzed because they had not reached the endpoint when the study was stopped.
Of the 242 patients in the analysis, 116 were in the randomized arm, including 51 assigned to receive a brace and 65 assigned to observation. Among the remaining 126 patients in the preference cohort, 88 chose a brace and 38 chose observation.
When both cohorts were analyzed together, the rate of treatment success was 72 percent after bracing and 48 percent after observation, yielding a propensity-score-adjusted odds ratio (OR) for treatment success of 1.93 (95 percent CI 1.08-3.46).
With the analysis restricted to the randomized cohort, the rate of treatment success was 75 percent among patients assigned to bracing and 42 percent among those assigned to observation (unadjusted OR 4.11, 95 percent CI 1.85-9.16), Weinstein and colleagues reported.
Most patients were fitted with a brace that recorded temperature and time as a means of quantifying the amount of time it was worn, the investigators noted.
During the first six months, they found, patients wore the brace for an average 12.1 hours a day, ranging from none to 23 hours.
While the study adds the "weight of the literature" in favor of bracing, Taylor noted that the patients might have been self-selected to have success, since about 65 percent of those screened and eligible did not take part in the study.
Indeed, the enrolment difficulties "must be considered in interpreting the results," commented Eugene Carragee, M.D., of Stanford University School of Medicine in Stanford, Calif., and Ronald Lehman, M.D., of the Walter Reed National Military Medical Center in Bethesda, Md.
In an accompanying editorial, they said that the associations between braces and treatment success might have been "inadvertently magnified" if participants whose curves were more likely to progress were less inclined to wear a brace -- something might have happened, for instance, if a patient had a relatively stiff curve that resisted the pressure of the brace.
Since the study also showed that some children did well without a brace, they concluded that "the challenge for the field going forward is to identify children who are most likely to benefit from bracing and those who are unlikely to benefit."