Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment in Patients With Lateral Epicondylitis

December 25, 2025 updated by: Nazife Kapan, Kirsehir Ahi Evran Universitesi

Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment on Pain, Function, Grip Strength and Tendon Thickness in Ultrasonography in Patients With Lateral Epicondylitis.

This study aimed to investigate the effects of Extracorporeal Shock Wave Therapy and phonophoresis treatment on pain, function, hand grip strength and tendon thickness in ultrasonography in patients with lateral epicondylitis.

Study Overview

Detailed Description

Lateral epicondylitis (LE) is tendinopathy of the forearm extensor muscles, often caused by overuse or repetitive use, forced wrist extension, or direct trauma to the epicondyle. It is the most common cause of lateral elbow pain. Although also known as tennis elbow, lateral epicondylitis often develops as a work-related condition and is therefore a significant public health problem.

ESWT; It involves transmitting high-intensity acoustic pressure waves produced by electrohydraulic, electromagnetic or piezoelectric devices to the target area of the body in a short time through the gel. It has been reported that ESWT increases collagen synthesis in tendons, bones and other soft tissues, accelerates vascularization and reduces pain.

ultrasound; It has been used for many years in the treatment of musculoskeletal disorders such as tendinitis, epicondylitis, tenosynovitis, bursitis and osteoarthritis. It produces acoustic waves through the conversion of electrical energy. These waves turn into heat as they pass through tissues at different resistance levels. Ultrasound is also used to enhance percutaneous absorption of drugs in phonophoresis applications.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kırşehir
      • Kırşehir, Kırşehir, Turkey (Türkiye)
        • Kırşehir Ahi Evran University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals aged 18-65
  • Those who signed the informed consent form
  • Painful palpation of the lateral epicondyle
  • Positive Mill's, Maudsley's and Cozen's tests
  • Patients who have had complaints for at least 3 months

Exclusion Criteria:

  • Those who have had corticosteroid, PRP, prolotherapy, hyaluronic acid etc. injections into the elbow area within 3 months or those who have received physical therapy
  • Those with cervical radiculopathy
  • Those who have had surgery on the elbow
  • Those with an open wound on the elbow
  • Those with a history of malignancy
  • Those with rheumatological diseases
  • Those with neurological diseases
  • Pregnancy
  • Infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Conventional Treatment Patients in this group will be given activity modification and home exercise program training, including stretching and eccentric strengthening exercises. Patients will be asked to perform the exercise treatment in 3 sets of 10 repetitions. Additionally, a splint will be recommended to rest the arm.
exercise and splint
Experimental: GroupB
Conventional Treatment and Phonophoresis Patients in this group will receive phonophoresis treatment in addition to a home exercise program and splint. A US device (Intelect 2776 Combo; Chattanoga Group, Inc, Chattanoga, TN) will be used for phonophoresis. The gel containing 10% naproxen will be mixed with aquasonic us gel to better deliver the drug through the body. Continuous mode at 1watt/cm2 1mhz frequency will be applied around the lateral epicondyle for 5 minutes. Sessions will be applied 5 sessions per week for 2 weeks.
exercise and splint
exercise, splint and phonophoresis
Experimental: Group C
Conventional Treatment and Ekstrakorporeal shock wave therapy Patients in this group will receive ESWT treatment in addition to a home exercise program and splint. ESWT; With the MODUS ESWT system, 2 sessions per week will be applied to the lateral epicondyle (2.4 bar intensity, 15 Hz frequency, 1500 pulses) for 2 weeks (Modus ESWT® RadialShockwaveTherapy).
exercise and splint
exercise, splint and ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: baseline, 2th week, 12th week
VAS is a pain rating scale with numbers 0 and 10. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale. Patients' night, rest and activity pain will be evaluated separately.
baseline, 2th week, 12th week
Patient-based lateral epicondylitis assessment questionnaire
Time Frame: baseline, 2th week, 12th week
It is a specific assessment questionnaire for lateral epicondylitis. It consists of two parts. In the first part, the pain in the affected arm is evaluated, and in the second part, the level of functionality is evaluated. In the second part, the functionality level is divided into two parts: specific activities and daily activities. In total, the best score is evaluated as 0 and the worst score is evaluated as 100.
baseline, 2th week, 12th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick-DASH
Time Frame: baseline, 2th week, 12th week
It is an evaluation questionnaire that measures activity and participation limitations in all upper extremity disorders. In the survey, patients' difficulties during daily living activities are questioned with 11 questions. Each answer is scored on a Likert scale from 1 to 5, from best to worst.
baseline, 2th week, 12th week
hand grip strength
Time Frame: baseline, 2th week, 12th week
It will be done with a Jamar dynamometer. Patients will be seated in a chair with their elbows flexed at 90 degrees and their forearms in a neutral position. They will be asked to squeeze the dynamometer for a maximum of 3 seconds, and this will be repeated 3 times, with a 60-second rest in the meantime. The average of 3 results will be recorded.
baseline, 2th week, 12th week
tendon thickness
Time Frame: baseline, 2th week, 12th week
Extensor tendon thickness measurement will be performed by the same researcher under clinical ultrasound guidance. Plato technique will be used. The plateau is located between the attachment site of the extensor tendon and the humeroradial joint. Tendon thickness is measured perpendicularly from the plateau to the tendon surface.
baseline, 2th week, 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lateral Epicondylitis

Clinical Trials on conventional treatment

Subscribe