The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •according to the Eaton et al. classification the inclusion criteria involved those patients with stage III, participants had to have a history 6 months of pain and they were 18 years of age or older.
排除标准
- •were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.
- •Exclusion Criteria:
- •Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.
结局指标
主要结局
Visual Analogue Scale
时间窗: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
It is a horizontal line, 10 cm in length with 0 cm labeled "no pain" and 10 cm labeled "worst pain I have ever had". The patient marks on the line the point that they feel represents their perception of their current state
Duruöz Hand Index (DHI)
时间窗: The change in the mean of DHI at 3 and 6 months follow up
is a self-report questionnaire which measures hand functional ability detecting how much difficulty the patient has performing eighteen daily tasks of living in reference to hand function. Each item is scored from 0 (performed without difficulty) to 5 (impossible to do). A total score is obtained by adding the scores of all questions (range 0-90). A higher score indicates greater disability. It was found that this scale is reliable and valid in patients with osteoarthritis
Disabilities of the Arm, Shoulder, and Hand questionnaire
时间窗: The changes in mean at 3 and 6 months follow up
It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). The score ranges from 0 to 100, where 0 disability and 100 most severe disability.
次要结局
- grip and pinch tests(The change in mean at 3 and 6 months follow up)
研究者
Francesco Ioppolo
MD, PhD
University of Roma La Sapienza