Impact on Quality of Life of Full-Time and Night-Time Braces in Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial.

Abstract

Study design: Randomized clinical trial.

Objective: To compare the effect on quality of life of night-time (NT) and full-time (FT) brace treatment for adolescent idiopathic scoliosis (AIS).

Summary of background data: Conservative treatment of adolescent idiopathic scoliosis (AIS) with full-time (FT) braces has proven to prevent the risk of progression and the need for surgery, with an inversely proportional relationship to the number of hours worn. However, therapeutic adherence and its effect on quality of life continue to pose a clinical challenge.

Materials and methods: Open-label clinical trial including AIS patients with curves between 25-45 degrees randomized to either NT or FT brace group. Follow-up occurred over two years, assessing treatment efficacy through radiographs and quality of life using SRS-22 and visual analog scale (VAS) questionnaires scores at baseline, 6 months, and 12 months. Compliance was monitored with thermal sensors every three months. Statistical analyses were conducted, with significance set at P < 0.05.

Results: 78 AIS patients, predominantly females (85.9%), were recruited, including 35 (44.87%) in FT group and 43 (55.13%) in NT. Initial Cobb angles were comparable between groups. Nine patients were excluded, and eight required surgery (NT 12.82%, FT 10%). After two years, both braces showed similar effectiveness in preventing curve progression. No differences on SRS-22 nor VAS scores were found before treatment. At six-month follow-up, NT group reported significantly better outcomes in "Self-image" compared to FT (P=0.047). After one year, NT patients reported less pain compared to baseline (P=0.048).

Conclusions: According to our results, both braces are equally effective in avoiding the progression of the deformity and need for surgery. However, FT brace has a higher impact on self-image and pain compared to NT brace.