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

1. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Ayşe Doğan, Ass Prof
  • Telefonnummer: 2241 00903642230300
  • E-mail: dr.mdagu@gmail.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Aktiv komparator: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity will be measured by the Visual Analog Scale (VAS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Grip strength will be measured using a Jamar hand dynamometer
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Pınar Başaran, Dr, Hitit university

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

29. april 2026

Primær færdiggørelse (Anslået)

29. september 2026

Studieafslutning (Anslået)

29. september 2026

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

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

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Kliniske forsøg med Lateral epikondylitis (tennisalbue)

Kliniske forsøg med ESWT Group

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