A comparison study on the efficacy of SpinoMed and soft lumbar orthosis for osteoporotic vertebral fracture

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. Clinical relevance In this study, SpinoMed could not provide additional treatment benefits to patients with osteoporotic vertebral fracture regarding pain relief and functional independence improvement at the subacute stage. The effects of SpinoMed in muscle-strengthening and thoracic kyphotic angle reduction for patients with osteoporotic vertebral fracture need to be further verified in a more intensive and longer-term training program.