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

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 AIS with 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 and 45° randomized to either NT or FT brace group. Follow-up occurred over 2 years, assessing treatment efficacy through radiographs and quality of life using SRS-22 and visual analog scale (VAS) questionnaire scores at baseline, 6 months, and 12 months. Compliance was monitored with thermal sensors every 3 months. Statistical analyses were conducted, with significance set at P < 0.05.

RESULTS

Seventy-eight AIS patients, predominantly females (85.9%), were recruited, including 35 (44.87%) in the FT group and 43 (55.13%) in the NT. Initial Cobb angles were comparable between groups. Nine patients were excluded, and eight required surgery (NT 12.82%, FT 10%). After 2 years, both braces showed similar effectiveness in preventing curve progression. No differences in SRS-22 nor VAS scores were found before treatment. At 6-month follow-up, the NT group reported significantly better outcomes in "self-image" compared with FT ( P =0.047). After 1 year, NT patients reported less pain compared with 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 with NT brace.