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| Whether orthotic management and exercise are equally effective to the patients with adolescent idiopathic scoliosis in mainland China: a randomized controlled trial study [with consumer summary] |
| Zheng Y, Dang Y, Yang Y, Li H, Zhang L, Lou EHM, He C, Wong MS |
| Spine 2018 May;43(9):E494-E503 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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STUDY DESIGN: Prospective randomized controlled trial OBJECTIVE: To investigate the effectiveness of orthotic management versus exercise on spinal curvature, body symmetry and quality of life. SUMMARY OF BACKGROUND DATA: A number of well-designed studies comparing conservative treatment of adolescent idiopathic scoliosis have been conducted and the evidence becomes stronger. However, there is a lack of the information on the effectiveness of orthotic management versus exercise. METHODS: The inclusion criteria recommended by the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) were used during enrollment. Eligible patients were randomly assigned to either bracing group or exercise group. Patients in the bracing group were prescribed with a rigid thoracolumbosacral orthosis and requested to wear 23 h/day, while patients in the exercise group were treated with the protocol of the Scientific Exercise Approach to Scoliosis. Data regarding angle of trunk inclination, Cobb angle, shoulder balance, body image, quality of life (QoL) were collected every 6 months. RESULTS: Twenty-four patients in the bracing group and 29 patients in the exercise group participated in this study. For the inter-group comparison, the bracing group showed better results about the correction of spinal curvature (Cobb angle at the first 12 months of intervention, p = 0.039), scores concerning quality of life, especially function (p < 0.001), mental health (p < 0.001) and total score (p < 0.001), were higher than that of the exercise group. The results of body symmetry evaluation did not differ significantly between the two groups. For the intra-group comparison, parameters of spinal curvature (baseline versus 12-month, p < 0.03 in the exercise group and p < 0.001 in the bracing group), QoL (baseline versus 12-month, p < 0.001) and TAPS (baseline versus 12-month, p < 0.033) significantly improved over the studied period. Shoulder balance (baseline versus 12-month, p < 0.005) showed significant improvement only in the bracing group. CONCLUSIONS: Both interventions of bracing and exercise showed significant treatment effectiveness on the patients with AIS. Bracing was superior to capture corrections in parameters of spinal curvature and body symmetry, while the QoL, especially in aspect of the functional and psychological status, was significantly better in the exercise group. LEVEL OF EVIDENCE: 1.
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