ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation

NCT ID: NCT06342518

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-12-01

Brief Summary

This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound.

Detailed Description

42 patients with tennis elbow were split into two groups by chance: one group received shock wave therapy (ESWT), while the other received a fake treatment (Sham-ESWT) for comparison. Both groups underwent wrist exercises, splint usage, and ice application. Grip strength, pain levels, and how well they could move their wrist (functionality) were measured before, after, and one month post-treatment using tests. Additionally, the thickness of a common extensor tendon (CET) was evaluated using ultrasound. The patient, the doctor checking the patient, and the doctor doing the ultrasound didn't know which group the patient was in.

Conditions

Lateral Epicondylitis; Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ESWT GROUP

The ESWT group received radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions.

A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (ESWT)

Intervention Type: DEVICE

The ESWT group received radial ESWT each session with a total of 2000 pulses at a frequency of 10 Hz. A gel was used at the interface, and the air pressure was set at 1.8 bar per session.

Resting Splint , Exercises and ice

Intervention Type: BEHAVIORAL

Ensuring proper usage of the wrist resting splint by the patient was confirmed during follow-up visits. The physician instructed the patients on stretching and strengthening exercises for wrist extensors, which they were asked to perform three times a day. Application of ice for 20 minutes every 3-4 hours during painful periods was recommended. During follow-up visits patients confirmed that they adherence to exercises and recommendations.

Sham-ESWT group

The Sham-ESWT group received Sham radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions.

A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.

Group Type: SHAM_COMPARATOR

Sham ESWT

Intervention Type: DEVICE

The Sham-ESWT group received Sham radial ESWT each session, but without actual contact of the applicator. To enhance the illusion of treatment, gel was applied, and the device emitted sound at every shock

Resting Splint , Exercises and ice

Intervention Type: BEHAVIORAL

Ensuring proper usage of the wrist resting splint by the patient was confirmed during follow-up visits. The physician instructed the patients on stretching and strengthening exercises for wrist extensors, which they were asked to perform three times a day. Application of ice for 20 minutes every 3-4 hours during painful periods was recommended. During follow-up visits patients confirmed that they adherence to exercises and recommendations.

Interventions

Extracorporeal Shock Wave Therapy (ESWT)

The ESWT group received radial ESWT each session with a total of 2000 pulses at a frequency of 10 Hz. A gel was used at the interface, and the air pressure was set at 1.8 bar per session.

Intervention Type: DEVICE

Sham ESWT

The Sham-ESWT group received Sham radial ESWT each session, but without actual contact of the applicator. To enhance the illusion of treatment, gel was applied, and the device emitted sound at every shock

Intervention Type: DEVICE

Resting Splint , Exercises and ice

Ensuring proper usage of the wrist resting splint by the patient was confirmed during follow-up visits. The physician instructed the patients on stretching and strengthening exercises for wrist extensors, which they were asked to perform three times a day. Application of ice for 20 minutes every 3-4 hours during painful periods was recommended. During follow-up visits patients confirmed that they adherence to exercises and recommendations.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• experiencing pain and tenderness in the lateral epicondyle while extending their wrist and fingers against resistance for at least 3 months

Exclusion Criteria

• Patients who are pregnant or have a coagulation disorder, cervical radiculopathy, peripheral neuropathy, peripheral vasculopathy in the upper extremity, complex regional pain syndrome, local infections, systemic inflammatory disease, fibromyalgia syndrome, arthritis (including rheumatoid arthritis, spondylarthritis, and crystal-induced arthropathies), malignancy, or those who have been treated with corticosteroids, PRP, or autologous blood injection, as well as those who have received physical therapy agents, undergone upper-extremity surgical interventions, or have a history of direct trauma to the elbow or a history of fracture,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Bilinç Doğruöz Karatekin

MD, Specialist of PMR,Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MU ESWT

Identifier Type: -

Identifier Source: org_study_id