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

Sponsor
Inonu University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05503615
Collaborator
(none)
15
1
2
18
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational
  • Other: IASTM Technique Application
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Muscle and Tendon Flexibility [Pre-treatment assessment.]

    Compression elastography method will be used to measure flexibility in the gastrocnemius muscle and achilles tendon of individuals.

  2. Evaluation of Muscle and Tendon Flexibility [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.

  3. Evaluation of Muscle and Tendon Thickness [Pre-treatment assessment.]

    Compression elastography method will be used to measure thickness in the gastrocnemius muscle and achilles tendon of individuals.

  4. Evaluation of Muscle and Tendon Thickness [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inonu University Malatya Turkey 44280

Sponsors and Collaborators

  • Inonu University

Investigators

  • Principal Investigator: Muhammed Üsame TAŞ, Lecturer, Inonu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muhammed Usame TAS, Principal Investigator, Inonu University
ClinicalTrials.gov Identifier:
NCT05503615
Other Study ID Numbers:
  • ÜSAME TAŞ-003
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 18, 2022