NCT05503615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 13, 2022

Last Update Submit

August 16, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Control Group

OTHER

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

IASTM Treatment Group

EXPERIMENTAL

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

Interventions

No application will be made to the control group.

Control Group

Instrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes.

IASTM Treatment Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Muhammed Üsame TAŞ, Lecturer

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammed Üsame TAŞ, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 16, 2022

Study Start

June 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations