Back to resultsThe Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal shock wave
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis
Eligibility Criteria
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
Sites / Locations
- Yuzuncu Yil University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Focus ESWT
Radial ESWT
Sham ESWT
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale
pain evaluation, higher scores mean a worse outcome.
Patient-Rated Tennis Elbow Evaluation
Scale, Higher scores represent higher level of pain and disability.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04838002
Brief Title
The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis
Official Title
Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis: A Randomised Sham-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Şeyhmus KAPLAN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focus ESWT
Arm Type
Active Comparator
Arm Title
Radial ESWT
Arm Type
Active Comparator
Arm Title
Sham ESWT
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave
Intervention Description
Focus and Radial types Extracorporeal shock wave therapy
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
pain evaluation, higher scores mean a worse outcome.
Time Frame
1 min.
Title
Patient-Rated Tennis Elbow Evaluation
Description
Scale, Higher scores represent higher level of pain and disability.
Time Frame
5 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şeyhmus Kaplan
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuzuncu Yil University
City
Van
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis
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