Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracorporeal Shoch Wave Therapy of the Patients With Lateral Epicondylitis: a Randomized Controlled Trial

August 22, 2024 updated by: Bihter Aslanyurek, Ankara Yildirim Beyazıt University

Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracarporeal Shock Wave Therapy on Pain Level, Muscle Strength, Joint Range of Motion, Functionality and Quality of Life in Patients With Lateral Epicondylitis: a Randomized Controlled Trial

To compare the effects of Trigger Point Ischaemic Compression Massage (TPICM) and Focused Extracarporeal Shock Wave Therapy (focused ESWT) on pain level, muscle strength, Joint range of motion, functionality and quality of life in patients with lateral epicondylitis (LE) in a randomised controlled trial.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The study was planned to include at least 66 patients who presented to the sports medicine clinic of Gülhane Training and Research Hospital with lateral epicondyle pain for at least 2 months, were diagnosed with lateral epicondylitis and verbally and in writing declared that they were willing to participate in the study.

Patients participating in the study;

  1. assessment of pain intensity with visual analog scale (VAS)
  2. Evaluation of hand grip strength with jamar hand dynamometer
  3. Isokinetic muscle strength assessment of wrist muscles with biodex isokinetic system 3
  4. assessment of wrist range of motion with a manual goniometer
  5. Function assessment with PRTEE-T
  6. DASH questionnaire
  7. SF-36 quality of life assessment will be performed before and after treatment.

inclusion criteria

  1. Male and female individuals aged 18-60 years
  2. being diagnosed with lateral epicondilitis
  3. volunteering to participate in the study

exclusion criteria from eswt treatment

  1. non-cooperation
  2. presence of systemic and metabolic diseases
  3. malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
  4. pregnancy
  5. utilization of another treatment for lateral epicondylitis during the study period
  6. previous invasive treatment with steroids for lateral epicondylitis
  7. any treatment for lateral epicondylitis in the last 6 months

Study Type

Interventional

Enrollment (Actual)

75

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

      • Ankara, Turkey, 06010
        • Gülhane Eğitim ve Araştırma Hastanesi

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female individuals between the ages of 18-60
  2. being diagnosed with lateral epicondylitis
  3. volunteering to participate in the study

Exclusion Criteria:

  1. non-cooperation
  2. presence of systemic and metabolic diseases
  3. malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
  4. pregnancy
  5. utilization of another treatment for lateral epicondylitis during the study period
  6. previous invasive treatment with steroids for lateral epicondylitis
  7. any treatment for lateral epicondylitis in the last 6 months

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focused Ekstracorporeal Shoch Wave Theraphy and Exercise
Individuals will be administered focused ekstracorporeal shoch wave theraphy 1 day a week for 4 weeks. Individuals will exercise every day
eswt treatment
Experimental: Trigger Point Ischemic Compression Massage and Exercise
Individuals will receive trigger point ischemic compression massage 2 days a week for 4 weeks. Individuals will exercise every day
eswt treatment
No Intervention: Exercise
Individuals will only exercise every day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
grip strenght asessment with jamar hand dynamometer
Time Frame: baseline-up to 4 weeks
It will be grip strength assessment with jamar hand dynamometer
baseline-up to 4 weeks
muscle strenght asessment with isocinetic system
Time Frame: baseline-up to 4 weeks
It will be elbow flexor and extansor muscle strength asessment with isocinetic system
baseline-up to 4 weeks
range of motion asessment with universal goniometer
Time Frame: baseline-up to 4 weeks
It will be elbow range of motion asessment with universal goniometer
baseline-up to 4 weeks
assessment of quality of life with quality of life questionnaire
Time Frame: baseline-up to 4 weeks
It will be asessment of quality of life with life questionnaire
baseline-up to 4 weeks
pain level asessment with visual analog scale
Time Frame: baseline-up to 4 weeks
It will be asessment of pain level with visual analog scale
baseline-up to 4 weeks
assessment of functionality with functionality questionnaire
Time Frame: baseline-up to 4 weeks
It will be asessment of functionality with functionality questionnaire
baseline-up to 4 weeks

Collaborators and Investigators

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

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, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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