The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis

April 7, 2021 updated by: Şeyhmus KAPLAN

Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis: A Randomised Sham-controlled Trial

To date, focused and radial types of extracorporeal shock wave therapy have been effectively used in lateral epicondylitis. However, studies directly addressing a comparison between radial and focused types of extracorporeal shock wave therapy in lateral epicondylitis have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused extracorporeal shock wave therapy options on lateral epicondylitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

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

  • Turkey
      • Van, Turkey
        • Yuzuncu Yil 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of lateral epicondylitis
  • be aged ≥18 at the time of diagnosis
  • be give informed consent

Exclusion Criteria:

  • be have not completed the assessment process.
  • elbow deformity
  • psychological illness

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham ESWT
Device: Extracorporeal shock wave
Focus and Radial types Extracorporeal shock wave therapy
Active Comparator: Focus ESWT
Device: Extracorporeal shock wave
Focus and Radial types Extracorporeal shock wave therapy
Active Comparator: Radial ESWT
Device: Extracorporeal shock wave
Focus and Radial types Extracorporeal shock wave therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 1 min.
pain evaluation, higher scores mean a worse outcome.
1 min.
Patient-Rated Tennis Elbow Evaluation
Time Frame: 5 min.
Scale, Higher scores represent higher level of pain and disability.
5 min.

Collaborators and Investigators

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

Sponsor

Şeyhmus KAPLAN

Investigators

  • Principal Investigator: Şeyhmus Kaplan, Yuzuncu Yıl University

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)

August 7, 2019

Primary Completion (Actual)

April 10, 2020

Study Completion (Actual)

April 10, 2020

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yuzuncu Yil University Turkey

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

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.

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