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

NCT04187287 | Completed

• 1 other identifier: 2017/48-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Tennis Elbow; Lateral Epicondylitis; Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Elbow and Forearm Pain

  will assessed using by visual analog scale

  Change from Baseline elbow and forearm pain at 3 weeks

Secondary Outcomes (5)

• Functionality

  Change from baseline functionality at 3 weeks

• Grip Strength

  Change from baseline grip strength at 3 weeks

• Change in the level of elbow and forearm edema

  Change from baseline edema at 3 weeks

• Range of motion of elbow joint

  Change from baseline range of motion at 3 weeks

• Change in the level of quality of life

  Change from baseline quality of life level at 3 weeks

Study Arms (2)

Radial Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR

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

Deep Friction Massage

ACTIVE COMPARATOR

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

Interventions

Radial Extracorporeal Shock Wave Therapy OTHER

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

Radial Extracorporeal Shock Wave Therapy

Deep Friction Massage OTHER

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.

Deep Friction Massage

Eligibility Criteria

• Age: 20 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Location

MeSH Terms

Conditions

Tennis Elbow; Tendinopathy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Ozge Gokalp, Asst. Prof

  Eastern Mediterranean University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 5, 2019
• Study Start: December 9, 2019
• Primary Completion: January 22, 2020
• Study Completion: January 31, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

CY (1)