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

1. května 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Pınar Başaran, Dr
  • Telefonní číslo: 2251 00903642230300
  • E-mail: pinarozge@yahoo.com

Studijní záloha kontaktů

  • Jméno: Ayşe Doğan, Ass Prof
  • Telefonní číslo: 2241 00903642230300
  • E-mail: dr.mdagu@gmail.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Aktivní komparátor: 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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain intensity will be measured by the Visual Analog Scale (VAS)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Grip strength will be measured using a Jamar hand dynamometer
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Pınar Başaran, Dr, Hitit university

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

29. dubna 2026

Primární dokončení (Odhadovaný)

29. září 2026

Dokončení studie (Odhadovaný)

29. září 2026

Termíny zápisu do studia

První předloženo

27. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

27. dubna 2026

První zveřejněno (Aktuální)

4. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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