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.