Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in upper limb function
研究概览
简要总结
Background:
Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion site of common extensor tendon to humerus. It is usually related to overuse of local muscle. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It applies shockwave energy to the lesion site, enhancing the growth of microvascularity, inducing tissue repair, and thus relieving the symptom.
The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.
Material and Methods
- Subjects: 30 patients will be recruited from outpatient department of physical medicine and rehabilitation department.
- Duration: 2013.09.01-2015.05.31
- Methods: The patients will be randomly divided into the experimental group and the control group through the draw, with 15 patients in each group. Patients in the experimental group receive rESWT plus routine rehabilitation program. Patients in the control group receive sham shockwave therapy plus routine rehabilitation program.
- Assessment: Before the therapy starts, patients who match the inclusion criteria will be evaluated using tools mentioned below:
- General data: age, sex, body height, body weight, affected side, medical history
- Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
- Assess severity of pain with Visual Analogue Scale (VAS)
- Assess grip strength with grip strength dynamometer
- Measure the size of tear (if any) of common extensor tendon through ultrasonography, and assess the texture of common extensor tendon through real-time sonoelastography (RTS)
Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and presentation on ultrasonography and RTS.
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 (Participant)
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
- •Aged > 18 years old
- •Lateral elbow pain lasting > 3 months
- •Pain induced by direct compression on the lateral epicondyle or common extensor tendon, resistant wrist extension and pronation in the elbow extension position, or static stretching of common extensor tendon through the palmer flexion in wrist pronation and elbow extension position
排除标准
- •Generalized inflammatory arthritis (e.g., rheumatic arthritis)
- •Pain at the proximal part of involved arm (e.g., shoulder pain, neck pain)
- •Pain other than elbow pain at the involved arm
- •Abnormal neurogenic symptom over the involved arm (e.g., radicular pain, hands numbness, hemiplegia)
- •Wound or skin lesion at the elbow of the involved arm
- •Pregnancy
- •Severe local or systemic infection
- •Malignancy
- •Coagulopathy
- •Cardiac pacemaker
- •History of surgical treatment at the elbow of the involved arm
- •Non-steroid anti-inflammatory drug (NSAID) use orally or topically at the elbow of the involved arm in the past week
- •Local steroid injection at the elbow of the involved arm in the past 3 months
- •Oral steroid use in the past 6 weeks
- •Refusal to sign the informed consent
- •Impairment in self-expression (e.g., dementia, aphasia)
- •Inability/unwillingness to participate in all the measurements.
结局指标
主要结局
Changes in upper limb function
时间窗: At baseline, 6 weeks, 12 weeks and 24 weeks
Upper extremity disability and symptoms were assessed using the Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
Changes in stiffness of common extensor tendon
时间窗: At baseline, 6 weeks, 12 weeks and 24 weeks
The changes in stiffness of common extensor tendon were assessed with sonoelastography. The images of sonoelastography were interpreted with the modified RTS scoring system and analyzed with color histogram.
Changes in grip strength
时间窗: At baseline, 6 weeks, 12 weeks and 24 weeks
Maximal grip strength of the involved arm was assessed using a grip strength dynamometer. Participants were asked to grip the dynamometer 3 times, at 15- second rest intervals, and the highest grip strength number was recorded.
Changes in pain intensity
时间窗: At baseline, 6 weeks, 12 weeks and 24 weeks
Participants were asked to rate their present pain intensity, as caused by the tennis elbow, from 0-10 using the Visual Analogue Scale (VAS). If participants had bilateral tennis elbow, the side with the worse pain intensity was chosen for the assessment.
次要结局
- Changes in size of tear within common extensor tendon(At baseline, 6 weeks, 12 weeks and 24 weeks)