Objectives: We conducted a prospective randomized study to evaluate the efficacy of two newly developed spinal orthoses in patients with vertebral fractures.
Design: We conducted a prospective, randomized, cross-over study to evaluate the efficacy of two newly developed spinal orthoses in patients with osteoporotic vertebral fractures. Measurements include trunk muscle strength, angle of kyphosis, body height, body sway, and parameters of quality-of-life such as pain, well-being, and limitations of daily living.
Results: Wearing the orthosis Spinomed during a 6-mo period (results of Spinomed active are given in parentheses) was associated with a 72% (64%) increase in back extensor strength (P < 0.01), a 44% (56%) increase in abdominal flexor strength (P < 0.01), an 11% (11%) decrease in the angle of kyphosis (P < 0.01), a 23% (20%) decrease in body sway (P = 0.03 and P = 0.02), a 19% (18%) increase in vital capacity (P < 0.01 and P = 0.03), a 41% (47%) decrease in average pain (P < 0.01), an 18% (18%) increase in well-being (P < 0.01), and a 49% (54%) decrease in limitations of daily living (P < 0.01), respectively. The overall tolerability of the orthoses was good; no adverse effects were reported and the dropout rate with 7% was rather low.
Conclusions: The use of an orthosis increases trunk muscle strength and therefore improves posture in patients with vertebral fractures caused by osteoporosis. In addition, a better quality-of-life is achieved by pain reduction, decreased limitations of daily living, and improved well-being. Thereby, the use of an orthosis may represent an efficacious nonpharmacologic treatment option for spinal osteoporosis.