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A comparison study on the efficacy of SpinoMed and soft lumbar orthosis for osteoporotic vertebral fracture [with consumer summary]
Li M, Law S-W, Cheng J, Kee H-M, Wong MS
Prosthetics and Orthotics International 2015 Aug;39(4):270-276
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; 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*

BACKGROUND: Osteoporosis is one of the major health problems in aging population and may lead to osteoporotic vertebral fracture that causes severe back pain and reduced functional independency. OBJECTIVES: To compare the efficacy of SpinoMed and soft lumbar orthosis at the subacute stage (the second and third weeks of disease onset) of the patients with osteoporotic vertebral fracture. STUDY DESIGN: Prospective randomized trial, pilot trial. METHODS: A total of 51 female subjects aged 55 years or above with osteoporotic vertebral fracture were randomly distributed to the soft lumbar orthosis (control group, n = 24) and SpinoMed (test group, n = 27) groups after the acute stage (the first week of disease onset). The pain level was assessed by obtaining verbally feedback in 10-point scale scoring, while functional mobility level was estimated with Functional Independence Measure-motor Scores, Elderly Mobility Scale, and Modified Functional Ambulation Category. The thoracic kyphosis angle was measured from standing x-ray on 10 out of 51 subjects. RESULTS AND CONCLUSION: Both groups showed significant reduction in the patients' pain level and limitations of daily life (p < 0.05). The effect of the two types of spinal orthoses on the pain level reduction and functional mobility level gain did not show significant difference (p > 0.05) at the subacute stage.

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