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

Not Applicable

Not yet recruiting

• Conditions: Lateral Epicondylitis; Extracorporeal Shock Wave Therapy; Phonophoresis

• Registration Number: NCT06603181
• Lead Sponsor: Kirsehir Ahi Evran Universitesi

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-05-07
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-09-30
• Primary Completion: 2025-01-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	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.
Patient-based lateral epicondylitis assessment questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
hand grip strength	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.
Quick-DASH	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.
tendon thickness	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.

Trial Locations

Locations (1)

Kırşehir Ahi Evran University; 🇹🇷 Kırşehir, Turkey