Shockwave Therapy Plus Exercise for Lateral Epicondylitis

Clinical Effectiveness of Extracorporeal Shock Wave Therapy Combined With Exercise in Patients With Lateral Epicondylitis

The primary objective of this study is to compare the clinical effectiveness of exercise therapy alone versus exercise combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals with lateral epicondylitis, focusing on changes in pain, grip strength, functional status, and overall treatment success.

Study Overview

• Status: Active, not recruiting
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Other: exercise therapy; Other: Extracorporeal Shock Wave Therapy (ESWT)

Detailed Description

This randomized, controlled, prospective clinical trial aims to compare the effectiveness of exercise therapy alone versus exercise therapy combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals diagnosed with lateral epicondylitis. The study is conducted at a single center and includes adult participants who meet predefined eligibility criteria.

Participants are randomly assigned to one of two groups: an exercise-only group and an exercise-plus-ESWT group. Both groups follow a 4-week treatment program consisting of 12 sessions delivered three times per week. The exercise program includes isometric, isotonic, and stretching exercises targeting wrist extensors and related musculature. These exercises are demonstrated and supervised by physiotherapists, with participants encouraged to continue them as a home program.

In the intervention group, ESWT is administered once weekly for a total of four sessions. A radial-type ESWT device is used with preset parameters (2.0 bar pressure, 10 Hz frequency, 2000 pulses per session). All ESWT applications are performed by trained physiotherapists.

Clinical assessments occur at baseline and at the end of the 4-week intervention. Pain intensity, upper-extremity functional capacity, and condition-specific functional limitations are measured using validated outcome tools. Global improvement is also recorded at post-treatment to evaluate the participant's perceived benefit.

This study is designed to provide comparative data on the added value of ESWT when combined with a structured exercise program for the management of lateral epicondylitis, with the goal of informing clinical decision-making and optimizing treatment strategies.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Beykoz
    • Istanbul, Beykoz, Turkey (Türkiye), 34000
      • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria: Individuals with the following characteristics will be included in the study:

• Being 18 years of age or older
• Having a clinical diagnosis of lateral epicondylitis
• Not having received any other similar treatment within the last 6 months
• Having the cognitive ability to understand the Turkish questionnaire and assessment forms
• Voluntarily agreeing to participate in the study and providing written informed consent

Exclusion Criteria: Individuals with one or more of the following conditions will be excluded from the study:

• Having a history of concomitant systemic, rheumatological, or inflammatory diseases that could affect pain
• Having a history of trauma, surgery, or neurological disease in the upper extremity
• Presence of conditions other than lateral epicondylitis, such as tendinopathy, bursitis, or nerve entrapment
• Having major psychiatric disorders that could affect the pain threshold (e.g., major depression, schizophrenia)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Group; Participants will be randomly assigned to two groups; one group will receive exercise therapy alone,	Other: exercise therapy; exercise therapy
Experimental: Extracorporeal Shock Wave Therapy (ESWT); Participants will be randomly assigned to two groups; one group will receive exercise therapy alone, while the other group will receive exercise plus Extracorporeal Shock Wave Therapy (ESWT). Clinical efficacy will be assessed by pre- and post-treatment measurements.	Other: Extracorporeal Shock Wave Therapy (ESWT); Extracorporeal Shock Wave Therapy (ESWT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.	Pain Intensity (Visual Analog Scale - VAS) Description: Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level on the line. Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse pain.	8 week
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH)	Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH) Description: Functional status will be measured using the QuickDASH questionnaire. Scores range from 0 (no disability) to 100 (severe disability). Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse functional impairment.	8 week

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Salih tan, doctorate, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lateral epicondylitis Extracorporeal Shock Wave Therapy
• 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; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy; Exercise Therapy
• Other Study ID Numbers: MST-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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