Night-Time Bending Brace vs. a TLSO in the Treatment of Adolescent Idiopathic Scoliosis: An IRB Prospective Randomized Trial
Methods: In November 1992, we received an IRB approval to prospectively randomize adolescents with the diagnosis of AIS, for whom a recommendation of brace management for their scoliosis had been made. The group would be randomized into two treatment arms, night-time bending brace (NBB) vs. traditional 20/24 hour TLSO management. Parents were given the approved informed consent packet.
The initial six patients/parents declined enrollment after reviewing the informed consent, and requested NBB management. We therefore proceeded by two of the attendings primarily utilizing the NBB and the other using the traditional TLSO, which was the preference of the attending involved. Thus, this study became a contemporary comparison of night-time bending brace management vs. TLSO brace management for AIS. Inclusion criteria were pragmatic. A diagnosis of AIS with a curve for which brace treatment was recommended. A vast majority of the night-time bending brace candidates were female (84%), average age at presentation was 12 years (range: 5 to 15 years)
67% were premanarcal, 79% were Risser 0-1. The average curve magnitude of the maximum curve was 28° (range: 14° to 46°).
We matched the NBB patients to similarly aged AIS patients treated with a TLSO brace. We excluded those children with a diagnosis of congenital, infantile, or neuromuscular scoliosis. Additionally, 15 patients who had initial treatment with a TLSO brace, and then were changed to a NBB for various reasons (most commonly, failure of correction in TLSO are kept as a separate group for reporting).
Results: Of the 45 adolescents in the night-time bending arm, 87% came to skeletal maturity with no surgical intervention, and 13% progressed to the point of having surgical care. We considered overall management a “success” in 80% (36/45). Success encompassed curve magnitude, physical appearance, pain, and magnitude of curve change in brace management without surgery.
In comparison to the curve magnitude at brace initiation, the curve at skeletal maturity for final evaluation was the same (within 5°) in 44%, improved at least 5° in 13%, increased 6°-10° in 20%, and increased 11° or greater in 22%.
Conclusion: NBB is effective in the management of patients with AIS. This study documents that in those with generally smaller curves of 20-40°, with an apex lower than T8, that initiation of brace management with NBB is as effective as TLSO management.
Significance: The use of NBB may be more acceptable to many parents and adolescents and as such, successful brace utilization may be encouraged. After initiation of treatment with an NBB, the curve progresses to an unsatisfactory level, then conversion to traditional 20/24 hour a day orthotic management may ensue.