Investigation of the Effect of Instrument-Assisted Soft Tissue Mobilization Technique on Flexibility and Thickness by Compression Elastography Method in Healthy Individuals.

August 16, 2022 updated by: Muhammed Usame TAS, Inonu University

Investigation of the Effect of Instrument-Assisted Soft Tissue Mobilization Technique on Flexibility and Thickness in Gastrokinemius Muscle and Achilles Tendon With Compression Elastography Method in Healthy Individuals.

Instrument-assisted soft tissue mobilization is an instrument-assisted soft tissue mobilization technique. It consists of stainless steel instrument designed to adapt to various tissues/shapes/curves of the body. The instruments were developed as an alternative to transverse friction massage. Stainless steel acts a bit like a diaposon when it comes into contact with fibrotic tissue. A resonance or reverberation in the instrument is created upon contact and transmitted through the instrument to the hands of the clinician. The application of heavy pressure (compared to light or medium pressure) using instruments has been proven to promote a greater fibroblastic response.

Instrument-assisted soft tissue mobilization is not used without insulation. It is imperative to use movement and strengthening in combination with soft tissue mobilization to promote tissue adaptation and remodeling. Mechanical loading has been shown to affect chondrocyte alignment and fibroblast activity with increased proteoglycan and collagen synthesis.

Elastography is an imaging method that allows the qualitative and quantitative evaluation of the biomechanical properties of tissues through USG. This imaging method provides information about the stiffness of the tissues independently of the acoustic impedance provided by B-mode examination and the vascular flow information provided by Doppler examination.

Compression elastography technique is based on the formation of strain (strain, displacement) in the compressed tissue. In hard tissues, displacement (strain) is less, while in soft tissues it is more. The displacement rates of the tissues are calculated by comparing the echo data obtained before and after the compression application. In compression elastography systems, the amount of pressure applied is indicated by an indicator on the screen.

The aim of this study was to investigate the effect of instrument-assisted soft tissue mobilization technique by compression elastography method on flexibility and thickness in gastrocnemius muscle and Achilles tendon in healthy individuals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the study, iASTM will be applied to healthy individuals and the effect of this technique will be examined. Demographic information of individuals will be recorded and individuals will be evaluated in detail in terms of muscle and tendon flexibility and thickness.

The work plan; pre-treatment evaluation, followed by treatment and second evaluation immediately after the end of treatment. The data collection period is planned as 1,5 year.

Study Type

Interventional

Enrollment (Anticipated)

15

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 Contact

Study Locations

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Consists of healthy individuals between the ages of 18-35,
  2. No history of orthopedic injury (muscle, tendon, joint capsule, ligament damage or peripheral neuropathy) in the lower extremities in the last 1 year,
  3. Being able to express himself without cognitive, cognitive and mental problems,
  4. Voluntarily agree to participate in the study.

Exclusion Criteria:

  1. Injury to any lower extremity between measurements during the treatment process,
  2. Having a BMI over 25,
  3. Surgery or arthritis in the last 1 year,
  4. Not being able or unwilling to do the tests,
  5. Not wanting to leave of their own accord.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Which leg of the individuals will be applied will be determined by the coin toss. After the money shot, the right leg will be applied when the writing comes, and the left leg will be applied when the tour comes. The leg to be applied includes the treatment group of the individuals; the other leg (the leg without application) will form the control group of individuals.
Other: Observational
No application will be made to the control group.
Experimental: IASTM Treatment Group
Which leg of the individuals will be applied will be determined by the coin toss. After the money shot, the right leg will be applied when the writing comes, and the left leg will be applied when the tour comes. The leg to be applied includes the treatment group of the individuals; the other leg (the leg without application) will form the control group of individuals.
Other: IASTM Technique Application
Instrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Muscle and Tendon Flexibility
Time Frame: Pre-treatment assessment.
Compression elastography method will be used to measure flexibility in the gastrocnemius muscle and achilles tendon of individuals.
Pre-treatment assessment.
Evaluation of Muscle and Tendon Flexibility
Time Frame: Second assessment immediately after the end of the 10-minute treatment.
Compression elastography method will be used to measure flexibility in the gastrocnemius muscle and achilles tendon of individuals.
Second assessment immediately after the end of the 10-minute treatment.
Evaluation of Muscle and Tendon Thickness
Time Frame: Pre-treatment assessment.
Compression elastography method will be used to measure thickness in the gastrocnemius muscle and achilles tendon of individuals.
Pre-treatment assessment.
Evaluation of Muscle and Tendon Thickness
Time Frame: Second assessment immediately after the end of the 10-minute treatment.
Compression elastography method will be used to measure thickness in the gastrocnemius muscle and achilles tendon of individuals.
Second assessment immediately after the end of the 10-minute treatment.

Collaborators and Investigators

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

Sponsor

Inonu University

Investigators

  • Principal Investigator: Muhammed Üsame TAŞ, Lecturer, İnönu 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)

June 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

August 13, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ÜSAME TAŞ-003

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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