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

Comparison of Effects of Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage on Individuals With Chronic Lateral Epicondylitis

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).

Study Overview

• Status: Completed
• Conditions: Tendinopathy; Lateral Epicondylitis; Tennis Elbow
• Intervention / Treatment: Other: Radial Extracorporeal Shock Wave Therapy; Other: Deep Friction Massage

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Famagusta,, Cyprus, 99628
    • Eastern Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radial Extracorporeal Shock Wave Therapy; 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.	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
Active Comparator: Deep Friction Massage; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elbow and Forearm Pain	will assessed using by visual analog scale	Change from Baseline elbow and forearm pain at 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	will assessed using by Patient-Rated Tennis Elbow Evaluation Questionnaire	Change from baseline functionality at 3 weeks
Grip Strength	will assessed using by hand grip	Change from baseline grip strength at 3 weeks
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
Range of motion of elbow joint	will evaluated using by goniometer	Change from baseline range of motion at 3 weeks
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

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Director: Ozge Gokalp, Asst. Prof, Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Arm Injuries; Elbow Tendinopathy; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 2017/48-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No