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Comparison of Extracorporeal Shock Wave Therapy and Low-Level Laser Therapy in Patients With Lateral Epicondylitis

1 maggio 2026 aggiornato da: Pınar Özge Başaran, Hitit University

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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Ayşe Doğan, Ass Prof
  • Numero di telefono: 2241 00903642230300
  • Email: dr.mdagu@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
ESWT will be applied to the lateral epicondyle region using a standardized protocol for 3 sessions in three weeks
Comparatore attivo: 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).
LLLT will be applied to the lateral epicondyle region using a standardized protocol three times per week for 3 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain intensity will be measured by the Visual Analog Scale (VAS)
Lasso di tempo: Baseline and after 3 weeks of treatment
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.
Baseline and after 3 weeks of treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Grip strength will be measured using a Jamar hand dynamometer
Lasso di tempo: Baseline and after 3 weeks of treatment
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.
Baseline and after 3 weeks of treatment
Ultrasonographic assessment of extensor tendon thickness
Lasso di tempo: Baseline and after 3 weeks of treatment
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.
Baseline and after 3 weeks of treatment
Elbow function and pain-related disability will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Lasso di tempo: Baseline and after 3 weeks of treatment
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.
Baseline and after 3 weeks of treatment
Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire
Lasso di tempo: Baseline and after 3 weeks of treatment
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.
Baseline and after 3 weeks of treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Pınar Başaran, Dr, Hitit university

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

29 aprile 2026

Completamento primario (Stimato)

29 settembre 2026

Completamento dello studio (Stimato)

29 settembre 2026

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to institutional regulations and the absence of participant consent for public data sharing.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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