NCT07638488

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

June 5, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

Trigger PointExtensor Carpi Radialis BrevisCommon Extensor TendonUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Change in Common Extensor Tendon Thickness

    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

Secondary Outcomes (3)

  • Change in Pain Intensity Assessed by Visual Analog Scale

    Baseline and week 4

  • Change in Grip Strength

    Baseline and week 4

  • Change in Functional Disability Assessed by the Duruöz Hand Index

    Baseline and week 4

Study Arms (2)

Active Trigger Point ESWT Group

EXPERIMENTAL

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.

Device: Extracorporeal Shock Wave Therapy

Sham Trigger Point ESWT Group

SHAM COMPARATOR

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.

Device: Extracorporeal Shock Wave TherapyDevice: Sham Extracorporeal Shock Wave Therapy

Interventions

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.

Active Trigger Point ESWT GroupSham Trigger Point ESWT Group

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.

Sham Trigger Point ESWT Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Medicine Hospital

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to whether the trigger point extracorporeal shock wave therapy application was active or sham. The care provider administering the intervention was not blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized into two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region. 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 same trigger point area.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start

October 21, 2024

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations