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A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial

2026年8月20日 更新者:Bihter Aslanyurek、Ankara Yildirim Beyazıt University

The Effects Of Combining Blood Flow Restriction Therapy With Extracorporeal Shock Wave Therapy On Pain, Muscle Strength, And Functional Outcomes İn Patients Diagnosed With Lateral Epicondylitis: a Randomized Controlled Trial

Lateral epicondylitis is a chronic degenerative tendinopathy characterized by pain, tenderness, decreased grip strength, and functional limitations, particularly on the outer part of the elbow. While conservative treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and extracorporeal shock wave therapy (ESWT) are used, surgical methods are considered as alternatives in resistant cases. ESWT reduces pain and inflammation by increasing vascularization in the targeted area and supporting tissue regeneration. Blood flow restriction therapy (BFR), on the other hand, promotes muscle hypertrophy and strength gains through low-intensity exercise. The biochemical effects of both methods increase cellular proliferation and protein synthesis through different mechanisms, thereby supporting tissue healing and functional recovery.

However, there are no studies in the literature examining the effects of combining ESWT and BFR in patients with lateral epicondylitis. Therefore, in our study, we aimed to evaluate the effects of the combined application of ESWT and BFR on pain, muscle strength, and functionality in the treatment of lateral epicondylitis.

Patients will be divided into two groups and will undergo treatment for a total of 4 weeks, with one session per week. The study group will receive ESWT treatment in combination with blood flow restriction therapy (BFR). The control group will receive only ESWT. In both groups, the intensity of the ESWT treatment will be increased between sessions based on the patient's pain tolerance. Pain levels, grip strength, wrist isometric muscle strength, and upper extremity functional status will be assessed in patients in both the treatment and control groups before and after treatment. The effectiveness of the methods will be statistically analyzed.

The findings obtained may contribute to the development of an innovative, evidence-based treatment protocol in the field of physical therapy and rehabilitation, thereby filling a gap in the literature aimed at improving pain management and functional recovery in the treatment of lateral epicondylitis.

調査の概要

詳細な説明

Lateral epicondylitis is a form of tendinitis characterized by pain at the attachment site of the common extensor tendons of the wrist to the lateral epicondyle, resulting from inflammation and degeneration (Kraushaar & Nirschl, 1999). It is most commonly seen in individuals aged 40-59, with a prevalence of 1.3% (Zhang et al., 2024). Common risk factors include female gender, obesity, a history of smoking, repetitive activities, and ipsilateral rotator cuff dysfunction (Shiri et al., 2006). Typically, pain on the lateral aspect of the elbow and forearm, restricted range of motion in the elbow and wrist joints, decreased muscle strength, and loss of function may be observed due to repetitive forearm supination/pronation and wrist extension (Shiri & Viikari-Juntura, 2011; G et al., 2024).

Treatment options include medical (oral and topical nonsteroidal anti-inflammatory drugs, local corticosteroid injections), conservative (cryotherapy, orthoses, electrotherapy, etc.), and surgical methods. Among conservative methods, Extracorporeal Shock Wave Therapy (ESWT) is frequently preferred (Lai et al., 2018). ESWT is a non-invasive method that utilizes high-frequency acoustic waves for therapeutic purposes in target tissues. This method supports tissue regeneration by enhancing angiogenesis at the tendon-bone junction through the stimulation of vascular endothelial growth factors and nitric oxide synthesis, and reduces pain by inhibiting pain receptors (Yoon et al., 2020). Additionally, it triggers the release of lubricin, which facilitates tendon repair and gliding by stimulating tenocyte proliferation through increased expression of TGFβ1 and IGF-1 (Zhang et al., 2011). The literature has demonstrated that ESWT has effects on lateral epicondylitis, such as alleviating pain, shortening recovery time, increasing grip strength, and enabling patients to return to their daily activities (Murat et al., 2024; Pettrone & McCall, 2005).

Another conservative method used in the treatment of lateral epicondylitis is Blood Flow Restriction Therapy (BFR). In this method, arterial blood flow is partially restricted and venous return is blocked by applying an external device (tourniquet or adjustable-pressure cuff) to the proximal part of the extremity (Patterson et al., 2019). This causes the targeted muscle group to work in an ischemic, hypoxic environment, triggering a significant increase in muscle mass and strength by activating fast-twitch muscle fibers (Gorgey et al., 2016; Scott et al., 2014). Studies investigating the effects of BFR on lateral epicondylitis have shown that it reduces pain, increases grip strength, and contributes to functional improvement (Karanasios et al., 2022; Kinandana et al., 2023).

In the literature, the effects of both methods on lateral epicondylitis have been examined separately, but their efficacy has not been compared. Therefore, the aim of our study is to compare the efficacy of extracorporeal shock wave therapy (ESWT) and blood flow restriction therapy (BFR) in patients with lateral epicondylitis. By comparing different treatment methods that can be used in the management of lateral epicondylitis symptoms, our study will contribute to the use of more personalized and effective treatment strategies by healthcare professionals and will serve as a guide for future research.

研究の種類

介入

入学 (推定)

52

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Ankara、トルコ(Türkiye)、06010
        • 募集
        • Gülhane Training and Research Hospital, Clinic of Sports Medicine
        • コンタクト:
        • コンタクト:
          • Merve GÖRGÜLÜ, PT, MSc Student
          • 電話番号:+905075916424
          • メール:merve3694@gmail.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  1. Having been diagnosed with lateral epicondylitis by a specialist physician
  2. Being between the ages of 18 and 60
  3. Having a body mass index (BMI) between normal weight (18.5-24.9 kg/m²) and overweight (25.0-29.9 kg/m²)
  4. Volunteering to participate in the study

Exclusion Criteria:

  1. Presence of a different elbow pathology
  2. Presence of bilateral lateral epicondylitis
  3. Presence of sensory and motor impairments in the upper extremities
  4. History of surgery in the elbow region
  5. History of systemic or metabolic disease
  6. History of diabetes mellitus
  7. History of hematological disease
  8. History of cardiac disease, heart failure, or coronary artery disease
  9. History of hypertension
  10. Malignancy
  11. History of peripheral vascular disease (presence of varicose veins/history, history of deep vein thrombosis, presence of lymphedema)
  12. Coagulation disorder
  13. Use of anticoagulants
  14. History of pulmonary disease
  15. History of pulmonary embolism
  16. Pregnancy
  17. Use of oral contraceptives
  18. Patients with a pacemaker
  19. History of trauma to the upper extremity within the past 6 months or 1 year

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Extracorporeal Shock Wave Therapy
Participants in this group will receive ESWT treatment once a week for 4 weeks for their elbows, which have been diagnosed with lateral epicondylitis.
Extracorporeal shock wave therapy will be performed using a Radial ESWT device. The intensity will be increased between sessions based on the patient's pain tolerance. The treatment will be administered once a week for 4 weeks.
実験的:Extracorporeal Shock Wave Therapy and Blood Flow Restriction Therapy
Participants in this group will receive ESWT and BFR treatment once a week for 4 weeks for their elbows, which have been diagnosed with lateral epicondylitis.
For blood flow restriction therapy, the occlusion pressure will be set at 40%-50% of the arterial occlusion pressure. During the 20-minute blood flow restriction therapy session, upper extremity strengthening, stretching, and stabilization exercises will be performed. The weight used in the strengthening exercises will be selected to be 20%-30% of 1 RM. Extracorporeal shock wave therapy will be performed using a Radial ESWT device. The intensity will be increased between sessions based on the patient's pain tolerance. The treatment will be administered once a week for 4 weeks.

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
Pain Intensity
時間枠:Baseline and at the end of 4 weeks
Pain intensity at rest, during activity, and at night will be assessed using the Visual Analog Scale (VAS).
Baseline and at the end of 4 weeks
Grip Strength
時間枠:Baseline and at the end of 4 weeks
The grip strength will be measured using a Jamar hand dynamometer.
Baseline and at the end of 4 weeks
Isometric Muscle Strength
時間枠:Baseline and at the end of 8 weeks.
Wrist isometric flexion and extension muscle strength will be assessed using the Nicholas MMT Hand-Held dynamometer.
Baseline and at the end of 8 weeks.
Functional Activity
時間枠:Baseline and at the end of 4 weeks
Functional activity will be assessed using the DASH (Disability of the Arm, Shoulder, and Hand) questionnaire.
Baseline and at the end of 4 weeks

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年4月3日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年4月1日

試験登録日

最初に提出

2026年8月20日

QC基準を満たした最初の提出物

2026年8月20日

最初の投稿 (実際)

2026年8月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月24日

QC基準を満たした最後の更新が送信されました

2026年8月20日

最終確認日

2026年5月1日

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