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Trigger Point Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis (LE-TP-ESWT)

5. juni 2026 opdateret af: Sueda SOYDAN, Gazi University

The Effect of Extracorporeal Shock Wave Therapy Applied to the Trigger Point on Grip Strength, Visual Analog Scale Score, and Common Extensor Tendon Thickness in Patients With Lateral Epicondylitis

This randomized controlled study evaluates the effect of extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point in patients with lateral epicondylitis. Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region. In addition, one group receives active extracorporeal shock wave therapy to the extensor carpi radialis brevis trigger point, while the other group receives sham extracorporeal shock wave therapy to the trigger point. Pain, grip strength, hand function, and common extensor tendon thickness are assessed before treatment and at week 4.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lateral epicondylitis is a common tendinopathic condition characterized by pain over the lateral elbow, reduced grip strength, and limitation in upper extremity function. The extensor carpi radialis brevis tendon and the common extensor tendon origin are frequently involved. Myofascial trigger points in the extensor carpi radialis brevis muscle may also contribute to pain and functional impairment.

This prospective randomized controlled single-blind study investigates whether extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point provides additional clinical and ultrasonographic benefit in patients with lateral epicondylitis. Participants are allocated to two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region once weekly for three sessions. The intervention group also receives active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle. The comparator group receives sham extracorporeal shock wave therapy to the same trigger point area.

Outcome assessments are performed at baseline and at week 4. Pain intensity is assessed using the Visual Analog Scale. Grip strength is measured with a Jamar hand dynamometer. Hand function is assessed using the Duruöz Hand Index. Common extensor tendon thickness is measured by ultrasonography. The primary aim is to determine whether active trigger point extracorporeal shock wave therapy provides additional improvement compared with sham trigger point application when both groups receive active treatment to the lateral epicondyle region.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyrkiet (Türkiye)
    • Ankara
      • Ankara, Ankara, Tyrkiet (Türkiye), 06560
        • Gazi University Faculty of Medicine Hospital

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

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age between 18 and 50 years
  • Clinical diagnosis of lateral epicondylitis
  • Tenderness over the lateral epicondyle
  • Presence of trigger point in the extensor carpi radialis brevis muscle
  • Ability to provide written informed consent

Exclusion Criteria:

  • Peripheral nerve disease involving the ulnar, median, or radial nerve
  • Other elbow pathologies such as instability, arthritis, or dermatologic lesions
  • Radicular pain
  • Previous elbow surgery
  • Platelet-rich plasma injection, stem cell injection, corticosteroid injection, or extracorporeal shock wave therapy to the affected elbow within the previous month
  • Presence of a pacemaker
  • Pregnancy

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: Active Trigger Point ESWT Group
Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions.
Enhed: Extracorporeal Shock Wave Therapy
Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions. In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle.
Sham-komparator: Sham Trigger Point ESWT Group
Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and sham extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions.
Enhed: Extracorporeal Shock Wave Therapy
Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions. In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle.
Enhed: Sham Extracorporeal Shock Wave Therapy
Sham extracorporeal shock wave therapy is applied to one trigger point in the extensor carpi radialis brevis muscle using a sham applicator that produces a similar sound but does not deliver therapeutic shock wave energy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Common Extensor Tendon Thickness
Tidsramme: Baseline and week 4
Common extensor tendon thickness is measured by ultrasonography using a linear probe with the elbow flexed at 90 degrees and the forearm in mid-supination. Measurements are performed on a longitudinal image at the lateral epicondyle region, perpendicular to the tendon fibers. The change from baseline to week 4 is evaluated
Baseline and week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity Assessed by Visual Analog Scale
Tidsramme: Baseline and week 4
Pain intensity is assessed using a 10-cm Visual Analog Scale. A score of 0 indicates no pain and a score of 10 indicates the worst pain.
Baseline and week 4
Change in Grip Strength
Tidsramme: Baseline and week 4
Grip strength is measured using a Jamar hand dynamometer. Measurements are performed with the participant seated, the shoulder adducted, the elbow flexed at 90 degrees, the forearm in neutral position, and the wrist in neutral position. Three consecutive measurements are obtained from the affected side, and the mean value is used for analysis. The change from baseline to week 4 is evaluated.
Baseline and week 4
Change in Functional Disability Assessed by the Duruöz Hand Index
Tidsramme: Baseline and week 4
functional disability is assessed using the Duruöz Hand Index. The scale includes 18 items evaluating difficulties in daily activities involving hand use. Total scores range from 0 to 90, with higher scores indicating greater disability. The change from baseline to week 4 is evaluated.
Baseline and week 4

Samarbejdspartnere og efterforskere

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

Sponsor

Gazi 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 (Faktiske)

21. oktober 2024

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LE-ESWT-ECRB-2026
  • KD24/04 (Anden identifikator: Başkent University Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared due to privacy and ethical restrictions.

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Kliniske forsøg med Lateral epikondylitis (tennisalbue)

Kliniske forsøg med Extracorporeal Shock Wave Therapy

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