Shockwave Therapy Plus Exercise for Lateral Epicondylitis

NCT ID: NCT07282431

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2026-02-15

Brief Summary

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.

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.

Conditions

Lateral Epicondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Participants will be randomly assigned to two groups; one group will receive exercise therapy alone,

Group Type: EXPERIMENTAL

exercise therapy

Intervention Type: OTHER

exercise therapy

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.

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (ESWT)

Intervention Type: OTHER

Extracorporeal Shock Wave Therapy (ESWT)

Interventions

Extracorporeal Shock Wave Therapy (ESWT)

Extracorporeal Shock Wave Therapy (ESWT)

Intervention Type: OTHER

exercise therapy

exercise therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

salih tan

Doctorate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salih tan, doctorate

Role: STUDY_DIRECTOR

Medipol University

Locations

Istanbul medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MST-1

Identifier Type: -

Identifier Source: org_study_id