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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05503615
Other study ID # ÜSAME TAS-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2022

Study information

Verified date August 2022
Source Inonu University
Contact Muhammed Üsame TAS, Lecturer
Phone +90 0534 681 25 85
Email fzt.muhammedusame.tas@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Observational
No application will be made to the control group.
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.

Locations

Country Name City State
Turkey Inonu University Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Muscle and Tendon Flexibility Compression elastography method will be used to measure flexibility in the gastrocnemius muscle and achilles tendon of individuals. Pre-treatment assessment.
Primary Evaluation of Muscle and Tendon Flexibility 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.
Primary Evaluation of Muscle and Tendon Thickness Compression elastography method will be used to measure thickness in the gastrocnemius muscle and achilles tendon of individuals. Pre-treatment assessment.
Primary Evaluation of Muscle and Tendon Thickness 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.
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