Instrument-assisted Soft Tissue MobilizationNCT05503615
Investigation of the Effect of Instrument-Assisted Soft Tissue Mobilization Technique on Flexibility and Thickness by Compression Elastography Method in Healthy Individuals.
A study testing Observational and IASTM Technique Application in people with Instrument-assisted Soft Tissue Mobilization and Flexibility, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Thickness
- What is being tested?
- Observational and IASTM Technique Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu University
Malatya, 44280
Muhammed Üsame TAŞ, Lecturer, +90 0534 681 25 85 ext. 4848, fzt.muhammedusame.tas@gmail.com
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Thickness, Compression Elastography, Rehabilitation
- Being tested
- Observational, IASTM Technique Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No application will be made to the control group.
IASTM Technique ApplicationOther
Instrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: IASTM Technique Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Muscle and Tendon Flexibility
Compression elastography method will be used to measure flexibility in the gastrocnemius muscle and achilles tendon of individuals.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Second assessment immediately after the end of the 10-minute treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jun 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instrument-assisted Soft Tissue MobilizationStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Usame TAS, Inonu University
- Investigators
- Muhammed Üsame TAŞ, Lecturer, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503615
- Sponsor's protocol ID
- ÜSAME TAŞ-003
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05503615
- Acronym / sponsor ID
- ÜSAME TAŞ-003
- Conditions
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Thickness, Compression Elastography, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: ObservationalWhich 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. |
| IASTM Treatment Group | Experimental | Other: IASTM Technique ApplicationWhich 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo application will be made to the control group. | Other | Control Group |
| IASTM Technique ApplicationInstrument-assisted soft tissue mobilization will be applied to the legs of the individuals to be treated with ultrasound gel for 2 minutes. | Other | IASTM Treatment Group |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed Üsame TAŞ, Lecturer principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observational and IASTM Technique Application in people with Instrument-assisted Soft Tissue Mobilization and Flexibility, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Üsame TAŞ, Lecturer (+90 0534 681 25 85 ext. 4848, fzt.muhammedusame.tas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Muscle and Tendon Flexibility (time frame: Pre-treatment assessment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.