Effects of two newly developed spinal orthoses on trunk muscle strength, posture, and quality-of-life in women with postmenopausal osteoporosis: a randomized trial.

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.

Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial.

OBJECTIVE: One fourth of women > or =50 yrs of age in the general population have one or more vertebral fractures. The orthotic treatment modality in the management of vertebral fractures caused by osteoporosis remains subjective because no objective data from clinical trials are available. The objective of this research was to evaluate the efficacy of a newly developed spinal orthosis in patients with osteoporotic vertebral fractures. DESIGN: We conducted a study that measured trunk muscle strength, angle of kyphosis, body height, body sway, and variables of quality of life such as pain, well-being, and limitations of daily living. RESULTS: Wearing the orthosis for 6-mo period was associated with a 73% increase in back extensor strength, a 58% increase in abdominal flexor strength, an 11% decrease in angle of kyphosis, a 25% decrease in body sway, a 7% increase in vital capacity, a 38% decrease in average pain, a 15% increase in well-being, and a 27% decrease in limitations of daily living. The overall tolerability of the orthosis was good, no side-effects were reported, and the drop-out rate of 3% was rather low. CONCLUSIONS: The use of an orthosis increases trunk muscle strength and thus 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. Therefore, the use of an orthosis may represent an efficacious nonpharmacologic treatment option for spinal osteoporosis.

Effects of vitamin D and calcium supplementation on falls: a randomized controlled trial.

Specific receptors for vitamin D have been identified in human muscle tissue. Cross-sectional studies show that elderly persons with higher vitamin D serum levels have increased muscle strength and a lower number of falls. We hypothesized that vitamin D and calcium supplementation would improve musculoskeletal function and decrease falls. In a double-blind randomized controlled trial, we studied 122 elderly women (mean age, 85.3 years; range, 63-99 years) in long-stay geriatric care. Participants received 1200 mg calcium plus 800 IU cholecalciferol (Cal+D-group; n = 62) or 1200 mg calcium (Cal-group; n = 60) per day over a 12-week treatment period. The number of falls per person (0, 1, 2-5, 6-7, >7 falls) was compared between the treatment groups. In an intention to treat analysis, a Poisson regression model was used to compare falls after controlling for age, number of falls in a 6-week pretreatment period, and baseline 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D serum concentrations. Among fallers in the treatment period, crude excessive fall rate (treatment - pretreatment falls) was compared between treatment groups. Change in musculoskeletal function (summed score of knee flexor and extensor strength, grip strength, and the timed up&go test) was measured as a secondary outcome. Among subjects in the Cal+D-group, there were significant increases in median serum 25-hydroxyvitamin D (+71%) and 1,25-dihydroxyvitamin D (+8%). Before treatment, mean observed number of falls per person per week was 0.059 in the Cal+D-group and 0.056 in the Cal-group. In the 12-week treatment period, mean number of falls per person per week was 0.034 in the Cal+D-group and 0.076 in the Cal-group. After adjustment, Cal+D-treatment accounted for a 49% reduction of falls (95% CI, 14-71%; p < 0.01) based on the fall categories stated above. Among fallers of the treatment period, the crude average number of excessive falls was significantly higher in the Cal-group (p = 0.045). Musculoskeletal function improved significantly in the Cal+D-group (p = 0.0094). A single intervention with vitamin D plus calcium over a 3-month period reduced the risk of falling by 49% compared with calcium alone. Over this short-term intervention, recurrent fallers seem to benefit most by the treatment. The impact of vitamin D on falls might be explained by the observed improvement in musculoskeletal function.