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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

20 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

52

Estágio

  • Não aplicável

Contactos e Locais

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Locais de estudo

      • Ankara, Turquia (Türkiye), 06010
        • Recrutamento
        • Gülhane Training and Research Hospital, Clinic of Sports Medicine
        • Contato:
        • Contato:
          • Merve GÖRGÜLÜ, PT, MSc Student
          • Número de telefone: +905075916424
          • E-mail: merve3694@gmail.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pain Intensity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de abril de 2025

Conclusão Primária (Estimado)

1 de abril de 2027

Conclusão do estudo (Estimado)

1 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

20 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de agosto de 2026

Primeira postagem (Real)

24 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de agosto de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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