Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis

March 13, 2023 updated by: KTO Karatay University

Short and Long Term Effects of Instrument Assisted Soft Tissue Mobilization and Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis

Pain, decreased grip strength, and loss of function are observed in individuals with lateral epicondylitis. The aim of this study is to investigate the effects of ESWT and IASTM applications on pain, grip strength and function in individuals with lateral epicondylitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Participants will be randomly divided into three groups: IASTM, ESWT and home exercise group. In addition to home exercise, IASTM and ESWT groups will be given 2 sessions per week for 4 weeks. Pain, grip strength and functionality of the participants will be evaluated before the application, after 4 weeks of application and 4 weeks after the end of the application.

Study Type

Interventional

Enrollment (Actual)

45

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
    • Karatay
      • Konya, Karatay, Turkey
        • KTO Karatay 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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • being diagnosed with chronic LET by a physician
  • visual analog scale (VAS) pain score ≥ 3

Exclusion Criteria:

  • any accompanying pathology in the wrist and forearm, such as a fracture or dislocation of the elbow;
  • treatment with corticosteroid injections in the past 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IASTM
In addition to the home exercise program application, IASTM application will be made for 4 weeks. IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute (Cheatham et al., 2019). The instruments will be applied to the soft tissue at 30º-60º angles, using vaseline as an intermediate, with a multidirectional "stroking" movement.
Other: IASTM
IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute.
Experimental: ESWT
ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application. Ultrasound gel will be used as an intermediate in the application. No anesthetic substance will be used before and after the application. Cold applications will be recommended for those who have pain after the application.
Other: ESWT
ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application.
Experimental: Home Exercise
Static stretching and eccentric strengthening exercises specific to the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks. For strengthening exercises, all patients will be asked to use green (medium resistance) elastic bands, hold them in a tense position for 10 seconds, let them back passively, and rest for 1 minute between sets. In the stretching exercise, they will be asked to stay in the most tense position for 30-45 seconds and rest for 30 seconds between stretching. In case of a painful situation, they will be asked to be informed about their information.
Other: Home Exercise
Special static stretching and eccentric strengthening exercises for the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Pain assessed by Visual Analog Scale.
Time Frame: Baseline, 4 weeks
Pain will be evaluated with Visual Analog Scale. 0 means no pain, 10 means unbearable pain.
Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: Baseline, 4 weeks
Grip strength will be evaluated with Hand Dynamometer
Baseline, 4 weeks
Function assessed by Patient-rated Forearm Evaluation Questionnaire
Time Frame: Baseline, 4 weeks
Function will be evaluated with Patient-rated Forearm Evaluation Questionnaire
Baseline, 4 weeks

Collaborators and Investigators

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

Sponsor

KTO Karatay University

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)

December 28, 2022

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KaratayUH6

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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