NCT00638768已完成2 期
Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Back pain as assessed by a numeric rating scale
研究概览
简要总结
The aim of this pilot study was to determine the effect of physiotherapy on impairments and health-related quality of life in people with a painful osteoporotic spinal fracture. It is hypothesised that physiotherapy will reduce impairments and improve quality of life in this patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •if female, at least five years post-menopause
- •aged > 50 years
- •primary osteoporosis defined as DXA T score < -2.5 at either the spine or proximal femur with at least one morphometric vertebral crush fracture sustained between 3 months to 2 years previously
- •back pain/discomfort in thoracic or lumbar region felt at least weekly within the last 6 months
- •stable dose of medication for treatment of osteoporosis (eg. hormone replacement therapy, bisphosphonates)
- •community dwelling and able to attend for treatment
- •English speaking
排除标准
- •secondary causes of bone loss such as osteomalacia, glucocorticoid medication etc.
- •co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
- •acute vertebral fracture in past 3 months
- •signs and symptoms arising from nerve root compression
- •back pain radiating into the lower limb
- •previous participation in a formal pain management program for back pain
- •physiotherapy for back pain in the past 6 months
- •allergic reaction to adhesive tape or poor skin condition that would prevent use of tape
结局指标
主要结局
Back pain as assessed by a numeric rating scale
时间窗: Baseline and 10 weeks
次要结局
- activity restriction, health-related quality of life and physical activity levels as well as overall perceived rating of change in back pain. Objective measures of thoracic kyphosis, standing balance, back and shoulder muscle endurance(Baseline and 10 weeks)
研究者
研究点 (2)
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