Comparison of Extracorporeal Shock Wave Therapy and Low-Level Laser Therapy in Patients With Lateral Epicondylitis
Effects of Extracorporeal Shock Wave Therapy Versus Low-Level Laser Therapy on Ultrasonographic Tendon Thickness and Clinical Outcomes in Patients With Lateral Epicondylitis
Background:
Lateral epicondylitis is a common musculoskeletal condition characterized by pain and functional impairment of the elbow, often associated with degenerative changes in the common extensor tendon. Extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) are widely used noninvasive treatment modalities; however, comparative evidence regarding their clinical and structural effects remains limited.
Objective:
This study aims to compare the effects of ESWT and LLLT on pain intensity, elbow function, quality of life, grip strength, and ultrasonographic characteristics of the extensor tendon (thickness and echogenicity) in patients with lateral epicondylitis.
Methods:
This prospective, randomized, single-blind, comparative clinical trial will be conducted at the Physical Medicine and Rehabilitation outpatient clinic. Patients aged 18-65 years with clinically diagnosed lateral epicondylitis and symptom duration of at least six weeks will be included. All participants will receive a tennis elbow brace and a standardized exercise program. Participants will be randomly assigned to receive either ESWT or LLLT. ESWT will be applied to the lateral epicondyle region using a standardized protocol once weekly for 3 weeks. LLLT will be administered to the same region using standard clinical protocol three times per week for 3 weeks.
Assessments will be performed before and after treatment. Pain will be evaluated using the Visual Analog Scale (VAS), elbow function using the Patient-Rated Tennis Elbow Evaluation (PRTEE), quality of life using the Short Form-36 (SF-36), and grip strength using a hand dynamometer. Ultrasonographic evaluation of the common extensor tendon will be performed by a blinded specialist using a high-frequency linear probe to assess tendon thickness.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Lateral epicondylitis is a common overuse disorder characterized by degenerative changes in the common extensor tendon, particularly the extensor carpi radialis brevis. Current evidence suggests that the condition represents a tendinopathic process rather than an inflammatory disorder, emphasizing the importance of treatments targeting both symptom relief and tendon healing.
Extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) are widely used noninvasive treatment modalities in clinical practice. ESWT is thought to promote tendon healing through mechanotransduction and neovascularization, whereas LLLT may enhance cellular metabolism, fibroblast proliferation, and collagen synthesis. Although both treatments have demonstrated clinical benefits, comparative data evaluating their effects on both clinical outcomes and tendon structure are limited.
This study is designed as a prospective, randomized, single-blind, comparative clinical trial conducted at the Physical Medicine and Rehabilitation outpatient clinic of Hitit University. Eligible participants aged 18-65 years with clinically diagnosed lateral epicondylitis and symptom duration of at least six weeks will be randomly assigned to receive either ESWT or LLLT using a computer-generated randomization sequence. Outcome assessors will be blinded to group allocation.
ESWT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol (1.6 bar, 2000 pulses, 10 Herz, once weekly for 3 weeks). LLLT will be administered to the same anatomical region three times per week for 3 weeks (four points, 40 seconds per point, 4 joules per square centimeter (J/cm²). In addition, all participants will receive a tennis elbow brace and a standardized exercise program. No additional physical therapy modalities or changes in ongoing medical treatments will be allowed during the study period.
Clinical assessments will be performed at baseline and immediately after treatment. Pain intensity will be measured using the Visual Analog Scale (VAS). Elbow function will be evaluated using the Patient-Rated Tennis Elbow Evaluation (PRTEE). Quality of life will be assessed with the Short Form-36 (SF-36), and grip strength will be measured using a hand dynamometer.
Ultrasonographic evaluation will be performed by an experienced physiatrist blinded to treatment allocation, using a high-frequency linear probe. The common extensor tendon will be assessed in both longitudinal and transverse planes. Tendon thickness will be measured in millimeters.
The primary aim is to compare the effects of ESWT and LLLT on pain and tendon thickness, while secondary outcomes include functional scores, quality of life, grip strength, and tendon echogenicity. It is hypothesized that both treatments will improve clinical outcomes, with ESWT potentially providing greater structural improvement in tendon characteristics.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Pınar Başaran, Dr
- Número de telefone: 2251 00903642230300
- E-mail: pinarozge@yahoo.com
Estude backup de contato
- Nome: Ayşe Doğan, Ass Prof
- Número de telefone: 2241 00903642230300
- E-mail: dr.mdagu@gmail.com
Locais de estudo
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Çorum, Turquia (Türkiye)
- Recrutamento
- Hitit University Erol Olçok Research Hospital Physical Medicine and Rehabilitation Clinic
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Contato:
- Ayşe Gülşen Doğan, Ass Prof
- Número de telefone: +905554734440
- E-mail: dr.mdagu@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Clinical diagnosis of lateral epicondylitis based on physical examination findings
- Symptom duration of at least 6 weeks
- Presence of lateral elbow pain aggravated by wrist extension and/or gripping activities
- Ability to understand and comply with study procedures
- Provision of written informed consent
Exclusion Criteria:
- Previous surgery involving the affected elbow
- History of corticosteroid or other injection therapy to the affected elbow within the last 6 months
- Presence of inflammatory rheumatic diseases (e.g., rheumatoid arthritis)
- Neurological disorders affecting the upper extremity
- Systemic inflammatory or metabolic diseases that may affect tendon structure or healing
- Cervical radiculopathy or other causes of referred upper extremity pain
- Pregnancy or breastfeeding
- Use of anticoagulant therapy or bleeding disorders
- Severe comorbid conditions that may interfere with participation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: ESWT Group
Participants in the experimental group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo extracorporeal shock wave therapy (ESWT).
ESWT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol (1.6 bar, 2000 pulses, 10 Herz, once weekly for 3 weeks).
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ESWT will be applied to the lateral epicondyle region using a standardized protocol for 3 sessions in three weeks
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Comparador Ativo: LLLT Group
Participants in the active comparator group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo low-level laser therapy (LLLT).
LLLT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol three times per week for 3 weeks at four points, 40 seconds per point, with a dose of 4 joules per square centimeter (J/cm²).
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LLLT will be applied to the lateral epicondyle region using a standardized protocol three times per week for 3 weeks
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain intensity will be measured by the Visual Analog Scale (VAS)
Prazo: Baseline and after 3 weeks of treatment
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Pain intensity will be measured by the Visual Analog Scale (VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will be asked to indicate their pain level, and the score will be recorded accordingly.
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Baseline and after 3 weeks of treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Grip strength will be measured using a Jamar hand dynamometer
Prazo: Baseline and after 3 weeks of treatment
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Grip strength will be measured using a Jamar hand dynamometer in a standardized position.
Measurements will be performed three times, and the average value will be recorded.
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Baseline and after 3 weeks of treatment
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Ultrasonographic assessment of extensor tendon thickness
Prazo: Baseline and after 3 weeks of treatment
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Extensor tendon thickness will be measured by an experienced physiatrist blinded to treatment allocation using ultrasonography.
Measurements will be performed over the common extensor tendon at the level of the lateral epicondyle using a high-frequency linear probe.
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Baseline and after 3 weeks of treatment
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Elbow function and pain-related disability will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Prazo: Baseline and after 3 weeks of treatment
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Elbow function and pain-related disability will be assessed by Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
The PRTEE is a validated, patient-reported outcome measure consisting of 15 items evaluating pain and functional limitations.
Scores range from 0 to 100, with higher scores indicating greater pain and disability.
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Baseline and after 3 weeks of treatment
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Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire
Prazo: Baseline and after 3 weeks of treatment
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Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, a validated instrument consisting of 36 items that evaluate eight domains of health-related quality of life, including physical functioning, bodily pain, and mental health.
Scores range from 0 to 100, with higher scores indicating better quality of life.
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Baseline and after 3 weeks of treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pınar Başaran, Dr, Hitit University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-15
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