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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ankara
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Ankara、Ankara、トルコ（Türkiye）、06560
- Gazi University Faculty of Medicine Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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|
偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Common Extensor Tendon Thickness
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Intensity Assessed by Visual Analog Scale
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LE-ESWT-ECRB-2026
- KD24/04 (その他の識別子：Başkent University Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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