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Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis

Primary Purpose

Tennis Elbow, Lateral Epicondylitis, Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Radial Extracorporeal Shock Wave Therapy
Deep Friction Massage
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow

Eligibility Criteria

20 Years - 66 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals with pain on the lateral epicondyle or proximal musculotendinous area of the forearm extensor muscles for at least 3 months,

  • Individuals with a positive Thomsen Test ,

    - Individuals who have not received physical therapy for lateral epicondylitis,

  • Individuals with a positive Maudsley Test will be included.

Exclusion Criteria:

  • Individuals who have received any physical therapy,
  • Individuals with reflected pain due to cervical and shoulder pathologies,
  • Individuals with elbow osteoarthritis,
  • Individuals with previous elbow fractures or elbow joint operations,
  • Individuals with a history of systemic inflammatory disease,
  • Individuals with osteoporosis,
  • Individuals with cardiovascular problems will not be included in the study.

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Radial Extracorporeal Shock Wave Therapy

Deep Friction Massage

Arm Description

Radial Extracorporeal Shock Wave Therapy will be given for 3 weeks, 1 days in a week. Moreover 10-12 minutes cold pack will apply for every session.

Deep Friction Massage treatment will be given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks.

Outcomes

Primary Outcome Measures

Elbow and Forearm Pain
will assessed using by visual analog scale

Secondary Outcome Measures

Functionality
will assessed using by Patient-Rated Tennis Elbow Evaluation Questionnaire
Grip Strength
will assessed using by hand grip
Change in the level of elbow and forearm edema
Elbow and forearm circumference area will be measured by using a tape measure.
Range of motion of elbow joint
will evaluated using by goniometer
Change in the level of quality of life
will evaluated using by short form 36

Full Information

First Posted
November 29, 2019
Last Updated
January 31, 2020
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT04187287
Brief Title
Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis
Official Title
Comparison of Effects of Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage on Individuals With Chronic Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the effects of Radial Extracorporeal Shockwave Therapy (rESWT) treatment and Deep Friction Massage (DFM) treatment on pain, functionality, grip strength (GS), edema, range of motion (ROM) of the elbow and quality of life in individuals with chronic lateral epicondylitis (CLE). 36 individuals diagnosed with CLE will be randomly divided into two equal groups. rESWT treatment will be applied to Group 1 and DFM treatment to Group 2. Visual analogue scale will be used to assess pain severity, functionality with Patient-Rated Elbow Evaluation Turkish version (PRTEE-T), GS with digital dynamometer, ROM of the elbow joint with goniometer, edema with environmental measurement, and quality of life with Short Form 36 (SF-36).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Lateral Epicondylitis, Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radial Extracorporeal Shock Wave Therapy
Arm Type
Active Comparator
Arm Description
Radial Extracorporeal Shock Wave Therapy will be given for 3 weeks, 1 days in a week. Moreover 10-12 minutes cold pack will apply for every session.
Arm Title
Deep Friction Massage
Arm Type
Active Comparator
Arm Description
Deep Friction Massage treatment will be given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks.
Intervention Type
Other
Intervention Name(s)
Radial Extracorporeal Shock Wave Therapy
Intervention Description
Radial Extracorporeal Shock Wave Therapy will given for 3 weeks, 1 days in a week. moreover 10-12 minutes cold pack will apply for every session
Intervention Type
Other
Intervention Name(s)
Deep Friction Massage
Intervention Description
Deep Friction Massage will given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks.
Primary Outcome Measure Information:
Title
Elbow and Forearm Pain
Description
will assessed using by visual analog scale
Time Frame
Change from Baseline elbow and forearm pain at 3 weeks
Secondary Outcome Measure Information:
Title
Functionality
Description
will assessed using by Patient-Rated Tennis Elbow Evaluation Questionnaire
Time Frame
Change from baseline functionality at 3 weeks
Title
Grip Strength
Description
will assessed using by hand grip
Time Frame
Change from baseline grip strength at 3 weeks
Title
Change in the level of elbow and forearm edema
Description
Elbow and forearm circumference area will be measured by using a tape measure.
Time Frame
Change from baseline edema at 3 weeks
Title
Range of motion of elbow joint
Description
will evaluated using by goniometer
Time Frame
Change from baseline range of motion at 3 weeks
Title
Change in the level of quality of life
Description
will evaluated using by short form 36
Time Frame
Change from baseline quality of life level at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals with pain on the lateral epicondyle or proximal musculotendinous area of the forearm extensor muscles for at least 3 months, Individuals with a positive Thomsen Test , - Individuals who have not received physical therapy for lateral epicondylitis, Individuals with a positive Maudsley Test will be included. Exclusion Criteria: Individuals who have received any physical therapy, Individuals with reflected pain due to cervical and shoulder pathologies, Individuals with elbow osteoarthritis, Individuals with previous elbow fractures or elbow joint operations, Individuals with a history of systemic inflammatory disease, Individuals with osteoporosis, Individuals with cardiovascular problems will not be included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Gokalp, Asst. Prof
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Study Director
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta,
ZIP/Postal Code
99628
Country
Cyprus

12. IPD Sharing Statement

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Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis

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