Clinical Effectiveness of Extracorporeal Shock Wave Therapy Combined With Exercise in Patients With Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.
研究概览
简要总结
The primary objective of this study is to compare the clinical effectiveness of exercise therapy alone versus exercise combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals with lateral epicondylitis, focusing on changes in pain, grip strength, functional status, and overall treatment success.
详细描述
This randomized, controlled, prospective clinical trial aims to compare the effectiveness of exercise therapy alone versus exercise therapy combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals diagnosed with lateral epicondylitis. The study is conducted at a single center and includes adult participants who meet predefined eligibility criteria.
Participants are randomly assigned to one of two groups: an exercise-only group and an exercise-plus-ESWT group. Both groups follow a 4-week treatment program consisting of 12 sessions delivered three times per week. The exercise program includes isometric, isotonic, and stretching exercises targeting wrist extensors and related musculature. These exercises are demonstrated and supervised by physiotherapists, with participants encouraged to continue them as a home program.
In the intervention group, ESWT is administered once weekly for a total of four sessions. A radial-type ESWT device is used with preset parameters (2.0 bar pressure, 10 Hz frequency, 2000 pulses per session). All ESWT applications are performed by trained physiotherapists.
Clinical assessments occur at baseline and at the end of the 4-week intervention. Pain intensity, upper-extremity functional capacity, and condition-specific functional limitations are measured using validated outcome tools. Global improvement is also recorded at post-treatment to evaluate the participant's perceived benefit.
This study is designed to provide comparative data on the added value of ESWT when combined with a structured exercise program for the management of lateral epicondylitis, with the goal of informing clinical decision-making and optimizing treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with the following characteristics will be included in the study:
- •Being 18 years of age or older
- •Having a clinical diagnosis of lateral epicondylitis
- •Not having received any other similar treatment within the last 6 months
- •Having the cognitive ability to understand the Turkish questionnaire and assessment forms
- •Voluntarily agreeing to participate in the study and providing written informed consent
排除标准
- •Individuals with one or more of the following conditions will be excluded from the study:
- •Having a history of concomitant systemic, rheumatological, or inflammatory diseases that could affect pain
- •Having a history of trauma, surgery, or neurological disease in the upper extremity
- •Presence of conditions other than lateral epicondylitis, such as tendinopathy, bursitis, or nerve entrapment
- •Having major psychiatric disorders that could affect the pain threshold (e.g., major depression, schizophrenia)
结局指标
主要结局
Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.
时间窗: 8 week
Pain Intensity (Visual Analog Scale - VAS) Description: Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level on the line. Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse pain.
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH)
时间窗: 8 week
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH) Description: Functional status will be measured using the QuickDASH questionnaire. Scores range from 0 (no disability) to 100 (severe disability). Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse functional impairment.
次要结局
未报告次要终点
研究者
salih tan
Doctorate
Istanbul Medipol University Hospital