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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Intervention / Treatment: Device: Extracorporeal Shock Wave Therapy; Device: Sham Extracorporeal Shock Wave Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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 Comparator: 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.	Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Assessed by Visual Analog Scale	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	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	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

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasonography; Trigger Point; Extensor Carpi Radialis Brevis; Common Extensor Tendon
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: LE-ESWT-ECRB-2026; KD24/04 (Other Identifier: Başkent University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy and ethical restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No