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| The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis [with consumer summary] |
| Wong MS, Cheng JC, Lam TP, Ng BK, Sin SW, Lee-Shum SL, Chow DH, Tam SY |
| Spine 2008 May 20;33(12):1360-1365 |
| clinical trial |
| 5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; 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: A prospective study on the comparison of the clinical efficacy and patient's acceptance of the 2 orthotic management methods. OBJECTIVE: To compare the treatment effectiveness and patients' acceptance of the flexible spinal orthosis, SpineCor with that of the rigid spinal orthosis for the patients with moderate adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: The patients' acceptance to the rigid spinal orthoses is always a concern as it could greatly affect the clinical outcome. SpineCor is a relatively new design for tackling those inevitable drawbacks found in rigid orthosis. However, there was no study to compare this design with the conventional method regarding their treatment efficacy and the patient's acceptance. METHODS: Forty-three subjects with moderate adolescent idiopathic scoliosis were randomly assigned to the SpineCor group (S group, n = 22) and rigid orthosis group (R group, n = 21). Their survival rate in the first 45 months of intervention was studied. The subjects' acceptance to the orthoses was evaluated by a purpose-designed questionnaire, which was administered in the 3rd, 9th, and 18th months of intervention. RESULTS: In the study period, there were 68% of the subjects in the S group and 95% of the subjects in the R group did not show curve progression. Significant difference (p = 0.046, by Fisher exact test) in failure rate between the 2 subject groups was found although the 2 groups had similar responses to the questionnaire. CONCLUSION: The current study showed that the failure rate of the SpineCor was significantly higher than that of the rigid spinal orthosis, and the patients' acceptance to the SpineCor was comparable to the conventional rigid spinal orthosis.
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