NCT03142971已完成不适用
Focused Extracorporeal Shock Wave Therapy for Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
Fondazione IRCCS Policlinico San Matteo di Pavia0 个研究点目标入组 50 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- LEFS score
研究概览
简要总结
The aim of this randomized controlled study is to investigate if focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.
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
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •duration of lateral hip pain of six weeks or longer,
- •normal passive hip range of movement (ROM),
- •sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter
排除标准
- •general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area),
- •history of rheumatologic disease,
- •previous fractures or surgery in the affected limb,
- •full thickness tear of the gluteal tendons,
- •osteoarthritis of the hip (with ROM limitation),
- •clinical signs of lumbar radiculopathy,
- •corticosteroid injections or other conservative therapies (except pharmacological pain treatments) since the onset of the current pain episode.
结局指标
主要结局
LEFS score
时间窗: Baseline, at two months, at six months
Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months
p-NRS
时间窗: Baseline, at two months, at six months
Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months.
次要结局
未报告次要终点
研究者
Ettore Carlis
MD
Fondazione IRCCS Policlinico San Matteo di Pavia
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