Trigger Point Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis (LE-TP-ESWT)
The Effect of Extracorporeal Shock Wave Therapy Applied to the Trigger Point on Grip Strength, Visual Analog Scale Score, and Common Extensor Tendon Thickness in Patients With Lateral Epicondylitis
研究概览
地位
条件
详细说明
Lateral epicondylitis is a common tendinopathic condition characterized by pain over the lateral elbow, reduced grip strength, and limitation in upper extremity function. The extensor carpi radialis brevis tendon and the common extensor tendon origin are frequently involved. Myofascial trigger points in the extensor carpi radialis brevis muscle may also contribute to pain and functional impairment.
This prospective randomized controlled single-blind study investigates whether extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point provides additional clinical and ultrasonographic benefit in patients with lateral epicondylitis. Participants are allocated to two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region once weekly for three sessions. The intervention group also receives active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle. The comparator group receives sham extracorporeal shock wave therapy to the same trigger point area.
Outcome assessments are performed at baseline and at week 4. Pain intensity is assessed using the Visual Analog Scale. Grip strength is measured with a Jamar hand dynamometer. Hand function is assessed using the Duruöz Hand Index. Common extensor tendon thickness is measured by ultrasonography. The primary aim is to determine whether active trigger point extracorporeal shock wave therapy provides additional improvement compared with sham trigger point application when both groups receive active treatment to the lateral epicondyle region.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ankara
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Ankara、Ankara、土耳其(türkiye)、06560
- Gazi University Faculty of Medicine Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Age between 18 and 50 years
- Clinical diagnosis of lateral epicondylitis
- Tenderness over the lateral epicondyle
- Presence of trigger point in the extensor carpi radialis brevis muscle
- Ability to provide written informed consent
Exclusion Criteria:
- Peripheral nerve disease involving the ulnar, median, or radial nerve
- Other elbow pathologies such as instability, arthritis, or dermatologic lesions
- Radicular pain
- Previous elbow surgery
- Platelet-rich plasma injection, stem cell injection, corticosteroid injection, or extracorporeal shock wave therapy to the affected elbow within the previous month
- Presence of a pacemaker
- Pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Active Trigger Point ESWT Group
Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions.
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Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions.
In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle.
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假比较器:Sham Trigger Point ESWT Group
Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and sham extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions.
|
Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions.
In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle.
Sham extracorporeal shock wave therapy is applied to one trigger point in the extensor carpi radialis brevis muscle using a sham applicator that produces a similar sound but does not deliver therapeutic shock wave energy.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Common Extensor Tendon Thickness
大体时间:Baseline and week 4
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Common extensor tendon thickness is measured by ultrasonography using a linear probe with the elbow flexed at 90 degrees and the forearm in mid-supination.
Measurements are performed on a longitudinal image at the lateral epicondyle region, perpendicular to the tendon fibers.
The change from baseline to week 4 is evaluated
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Baseline and week 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Pain Intensity Assessed by Visual Analog Scale
大体时间:Baseline and week 4
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Pain intensity is assessed using a 10-cm Visual Analog Scale.
A score of 0 indicates no pain and a score of 10 indicates the worst pain.
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Baseline and week 4
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Change in Grip Strength
大体时间:Baseline and week 4
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Grip strength is measured using a Jamar hand dynamometer.
Measurements are performed with the participant seated, the shoulder adducted, the elbow flexed at 90 degrees, the forearm in neutral position, and the wrist in neutral position.
Three consecutive measurements are obtained from the affected side, and the mean value is used for analysis.
The change from baseline to week 4 is evaluated.
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Baseline and week 4
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Change in Functional Disability Assessed by the Duruöz Hand Index
大体时间:Baseline and week 4
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functional disability is assessed using the Duruöz Hand Index.
The scale includes 18 items evaluating difficulties in daily activities involving hand use.
Total scores range from 0 to 90, with higher scores indicating greater disability.
The change from baseline to week 4 is evaluated.
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Baseline and week 4
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- LE-ESWT-ECRB-2026
- KD24/04 (其他标识符:Başkent University Clinical Research Ethics Committee)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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研究美国 FDA 监管的药品
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