Comparison of the Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Change Patient-rated Tennis Elbow Evaluation score
研究概览
简要总结
No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the lack of evidence. Although conflicting results are present, radial extracorporeal shock wave therapy (rESWT) has increasingly been used in the treatment of tendinopathy
详细描述
ESWT and exercise have beneficial effects on the management of tendinopathies owing to their various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes, extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific rotator cuff tendinopathies, and patellar 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
- Double (Investigator, 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
- •The diagnosis of LE was made in the clinical examination, and the diagnosis was confirmed with the Southampton Diagnostic Criteria of "the presence of epicondyle pain, and epicondyle pain and tenderness on resisted extension of the wrist.
- •Patients with symptoms lasting longer than 3 months
- •with average pain in the previous week detected as 3 or above on a 10-cm visual analogue scale (VAS)
- •who were aged over 18 years
排除标准
- •pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain)
- •abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity
- •presence of posterior interosseous nerve entrapment
- •congenital or acquired upper extremity deformities that might affect grip strength
- •systemic musculoskeletal system or neurologic disorders
- •systemic rheumatologic disease or systemic infection
- •presence of malignancy, coagulation disorders, and anticoagulant use
- •inserted cardiac pacemaker
- •history of surgical treatment on the elbow of the affected extremity
- •pregnancy.
- •patients who were administered other treatments such as physical therapy or steroid injections in the last 3 months
研究组 & 干预措施
rESWT
the group receiving rESWT
干预措施: rESWT (Device)
supervised exercises
the group receiving supervised exercises
干预措施: Supervised exercises (Other)
结局指标
主要结局
Change Patient-rated Tennis Elbow Evaluation score
时间窗: Change from Baseline at 1 month and 3 months after treatment.
The Patient-rated Tennis Elbow Evaluation is a specific questionnaire designed for the evaluation of the disease-specific pain and function/disability in LE. The scores were calculated separately and as the total PRTEE score, where 0 represented the best score, and 100 represented the worst score. The PRTEE consists of a pain scale with 5 items questioning pain during rest and specific activities (0 represents 'no pain' and 10 represents 'the highest pain'), and a function/disability scale with 10 items evaluating difficulties experienced during specific and daily activities (0 represents 'no difficulty' and 10 represents 'the highest difficulty)
次要结局
- Change Visual Analogue Scale score(Change from Baseline at 1 month and 3 months after treatment.)
- Change Roles and Maudsley Score(Change from Baseline at 1 month and 3 months after treatment.)
- Change Grip Strength score(Change from Baseline at 1 month and 3 months after treatment.)
研究者
MUSTAFA CORUM
Principal Investigator
Istanbul University