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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04187287
Other study ID # 2017/48-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 9, 2019
Est. completion date January 31, 2020

Study information

Verified date January 2020
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 31, 2020
Est. primary completion date January 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 66 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Radial Extracorporeal Shock Wave Therapy
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
Deep Friction Massage
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.

Locations

Country Name City State
Cyprus Eastern Mediterranean University Famagusta,

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Elbow and Forearm Pain will assessed using by visual analog scale Change from Baseline elbow and forearm pain at 3 weeks
Secondary Functionality will assessed using by Patient-Rated Tennis Elbow Evaluation Questionnaire Change from baseline functionality at 3 weeks
Secondary Grip Strength will assessed using by hand grip Change from baseline grip strength at 3 weeks
Secondary Change in the level of elbow and forearm edema Elbow and forearm circumference area will be measured by using a tape measure. Change from baseline edema at 3 weeks
Secondary Range of motion of elbow joint will evaluated using by goniometer Change from baseline range of motion at 3 weeks
Secondary Change in the level of quality of life will evaluated using by short form 36 Change from baseline quality of life level at 3 weeks
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