Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis

January 8, 2023 updated by: Bezmialem Vakif University

Comparing the Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis: A Randomized Controlled Trial

The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lateral epicondylitis is the most common cause of elbow lateral pain in adults. Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. The main complaints being pain and decreased grip strength, both of which may affect activities of daily living. The patient's complaints regress with rest,but but can increase again during daily activities such as grasping, repetitive hand movements, holding door handles, turning keys, lifting heavy loads. Diagnosis of lateral epicondylitis is largely based on clinical history and examination. Conservative treatment is the first line treatment. Generally, %90 of patients with LE benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity modification, topical and oral NSAIDs, splinting, stretching and strengthening exercises, various injections, prolotherapy and electrotherapy modalities. Laser, TENS, ultrasound, phonophoresis, iontophoresis and ESWT are electrotherapeutic agents that can be used in therapy to relieve pain and promote healing. Research on physical treatments for LE has not yet proven superiority of one specific approach.

Although many studies have been done for ESWT, ultrasound and phonophoresis, there is not any study that compares these three modalities.In addition, there ara fewer studies about measuring the effect of these treatment methods which contain control groups. In this study, our aim is to investigate the efficacy of ESWT, ultrasound therapy and phonophoresis methods used in the treatment of LE and to compare the efficacy of these three treatments against each other and control group.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 18-65 years
  • Pain on the lateral side of the elbow for at least 4 weeks
  • Tenderness over the lateral epicondyle
  • Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test)

Exclusion Criteria:

  • Be younger than 18
  • Having had ESWT treatment in the elbow area before
  • History of injection, surgery, physical therapy in the elbow area in the last 3 months
  • Previous elbow surgery
  • History of radius/ulna fracture
  • A history of cervical and shoulder problems
  • having bilateral symptoms
  • concomitant medial epicondylitis
  • Malignancy
  • Pregnancy
  • Systemic rheumatologic disease or systemic infection
  • inserted cardiac pacemaker
  • presence of coagulation disorders
  • Cognitive disfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: ESWT(Extracorporeal Shock Wave Therapy)
Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program
Device: ESWT

Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program

Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Experimental: Phonophoresis
Group 2 ( n=17) will be given five times a week, total 10 sessions of diclofenac phonophoresis + home exercise program
Device: Phonophoresis

Group 2 ( n=17) will be given five times a week total 10 sessions of diclofenac phonophoresis + home exercise program

Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Experimental: Ultrasound therapy
Group 2 (n=17) will be given five times a week, total 10 sessions of ultrasound therapy+ home exercise program
Device: Ultrasound

Group 3 (n=17) will be given five times a week total 10 sessions of ultrasound therapy+ home exercise program

Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Other: Control goup
Group 4 ( n=17) will be given home exercise program
Other: Control group
Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Change from Baseline at 1 month after treatment.
The self-evaluation of pain severity during rest, activity,night and with palpation was calculated using a 10-cm VAS scale
Change from Baseline at 1 month after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Rated Tennis Elbow Evaluation (PRTEE) scales
Time Frame: Change from Baseline at 1 month after treatment.
The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis
Change from Baseline at 1 month after treatment.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score
Time Frame: Change from Baseline at 1 month after treatment.
The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness
Change from Baseline at 1 month after treatment.
Roles and Maudsley Score
Time Frame: Change from Baseline at 1 month after treatment.
The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, 2 points = good, 3 points = fair and 4 points = poor.
Change from Baseline at 1 month after treatment.
Health Assessment Questionnaire (HAQ) score
Time Frame: Change from Baseline at 1 month after treatment.
This is a self-reported questionnaire covering 20 items in eight domains related to measuring difficulty in performing activities of daily living: dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities
Change from Baseline at 1 month after treatment.
Grip Strength score
Time Frame: Change from Baseline at 1 month after treatment.
Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer
Change from Baseline at 1 month after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Director: Okan Küçükakkaş, Doç, okan4494@yahoo.com
  • Principal Investigator: Elif Uğurlu, MD, elifdemirbag92qgmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

January 6, 2023

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71306642-050.05.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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