Comparison of the Effect of a Weight Bearing Protocol and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change of physical disability
研究概览
简要总结
The effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. Therefore, the investigators plan to make a comparison of the effect of a weight bearing protocol and a non-weight bearing protocol on osteoporotic women with chronic low back pain.
40 women with osteoporosis and low back pain will be divided into two groups. Each group will be given a specific exercise protocol, twice a week for four weeks, 45 minutes each time. The participants will be tested before starting the program, immediately after finishing it and again two months later. The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS (Visual Analogue Scale) and lumbar range of motion measurement by a digital Inclinometer.
Statistical analysis will be made in order to compare the dependent variables between groups.
详细描述
40 women with osteoporosis and low back pain will be recruited by referral of doctors to the physical therapy clinic in Bat-Yam, Israel. Each woman will be tested by one investigator after meeting the criteria of eligibility and after obtaining formed consent . The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS and lumbar range of motion measurement by a digital Inclinometer. By order of appearance, each participant will be assigned to one of two groups - weight bearing group or non-weight bearing group. After recruiting at least 3 participants in each group, a different investigator will begin a specific exercise protocol for each of the groups for four weeks - twice a week, 45 minutes each time, a total of 8 sessions. After each participant finishes all 8 sessions, she will be tested for the second time by the first investigator, the same tests as the first time. A third identical test will be preformed two months after finishing the program.
After all the participants finish the program statistical analysis will be made in order to compare the dependent variables between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
the investigator will check all the participants without knowing to which group they are assigned to
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with osteoporosis (T score lower than -2.5)
- •women whom had suffered from non specific low back pain for the last 3 months or more.
排除标准
- •history of operations in the spine
- •history of cancer or neurologic disease
- •history of fractures
- •previous trauma to the spine
- •persons whom for any reason cannot sit on a chair or lie on a mattress for 45 minutes
结局指标
主要结局
Change of physical disability
时间窗: 3 months
the Roland Morris Disability Questionnaire. The score of the questionnaire is the total number of items checked - i.e. from a minimum of 0 to a maximum of 24.
次要结局
- change in pain intensity(3 months)
- change in lumbar range of motion - flexion and extension(3 months)
- change in health related quality of life(3 months)