Instrument-assisted Soft Tissue MobilizationNCT06529926
Investigation of The Effect of "Instrument-Assisted Soft Tissue Mobilization" in Individuals With Lumbar Disc Herniation
A study testing Observational and IASTM Technique Application in people with Instrument-assisted Soft Tissue Mobilization and Treatment, 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 20 to 60 years
- Conditions the study is for
- Instrument-assisted Soft Tissue Mobilization, Treatment, Exercise
- What is being tested?
- Observational and IASTM Technique Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 31 Dec 2018
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals have been diagnosed with LDH,
- Their pain is 3 and above according to the Visual Analog Scale (VAS),
- They are between the ages of 20-60,
- Their clinical status is stable,
- They are fully cooperative,
- They do not have cognitive, cognitive and mental problems and they can express themselves,
- They voluntarily agree to participate in the study.
Who cannot join
- Individuals have psychological disorders, mental disorders, cancer and severe depression,
- Primary or metastatic spinal malignancy,
- Have been diagnosed with advanced osteoporosis,
- Have recently undergone surgical intervention or acute infection,
- Cannot or do not want to perform tests or treatment exercises,
- Want to leave voluntarily.
Trial locations and contacts
1 site in 1 country.
About this study
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. The aim of this study was to investigate the effects of the IASTM technique on individuals of different ages diagnosed with LDH.
- Being tested
- Observational, IASTM Technique Application
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Only classical physiotherapy application for 4 weeks.
IASTM Technique ApplicationOther
IASTM application for 2 sessions per week with classical physiotherapy for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Treated with classical physiotherapy (Hotpack+TENS+Ultrasound) program. A 20-minute hotpack was applied to the lumbar area. TENS and ultrasound were applied as electrotherapy agents. The TENS application was made with the Chattanooga Intelect Advanced Combo device. Conventional tens was applied at a frequency of 100 Hz for 20 min with a current of 100 μs. The ultrasound application was made with the Chattanooga Intelect Advanced Combo device. Lumbar area was administered at a dose of 1 MHz, 1.5 W/cm² using a 5 cm diameter cap for 6 min. In the first session, the physiotherapist had the patient explain the exercises (posterior pelvic tilt exercise, hip flexors stretching exercise, lumbar extensors stretching exercise, abdominal muscle strengthening exercise, SLR exercise, pelvic elevation exercise, cat-camel exercise and lumbar extensor strengthening exercise). Afterwards, patients were advised to rest for 1 minute between exercises, 1 time a day and for 4 weeks, 5 days a week. Receives: Other: Observational |
| IASTM Treatment Group | Experimental | IASTM application was applied at an angle of 45° in a direction parallel to the muscle fibers for about 20 seconds. Immediately afterwards, a total of 40 seconds of treatment time was applied by treating the muscle fibers at a 45° angle with the instrument for an additional 20 seconds in a direction perpendicular to them. In other words, for each area (paraspinal muscles, gluteus maximus and gluteus medius muscles, hamstrings), a total of 2 minutes was applied to the right and left sides separately for 40x3 seconds. Paraspinal muscles were treated from caudal to cranium, gluteal muscles from proximal to distal and hamstring muscles from popliteal fossa to gluteal line. Stretching was provided by exercises applied to the control group. After the cold application, IASTM application was made, the cold-pack was applied to each area for 5 minutes. (The application was performed by a trained and experienced physiotherapist and with a stainless steel gua sha device). Receives: Other: IASTM Technique Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Pain
Visual analog scale was used to evaluate the pain of the patients.
Measured: Pre-treatment assessment.
Evaluation of Pain
Visual analog scale was used to evaluate the pain of the patients.
Measured: After 4 weeks of treatment (Post-treatment assessment).
Evaluation of Pain
Visual analog scale was used to evaluate the pain of the patients.
Measured: 2nd month post-treatment assessment.
Evaluation of Functional Status (Straight leg raise test)
Straight leg raise test was used to evaluate the functional status of the patients.
Measured: Pre-treatment assessment.
Evaluation of Functional Status (Straight leg raise test)
Straight leg raise test was used to evaluate the functional status of the patients.
Measured: After 4 weeks of treatment (Post-treatment assessment).
Evaluation of Functional Status (Straight leg raise test)
Straight leg raise test was used to evaluate the functional status of the patients.
Measured: 2nd month post-treatment assessment.
Evaluation of Functional Status (Slump test)
Slump test was used to evaluate the functional status of the patients.
Measured: Pre-treatment assessment.
Evaluation of Functional Status (Slump test)
Slump test was used to evaluate the functional status of the patients.
Measured: After 4 weeks of treatment (Post-treatment assessment).
Evaluation of Functional Status (Slump test)
Slump test was used to evaluate the functional status of the patients.
Measured: 2nd month post-treatment assessment.
Evaluation of Functional Status (5-min walking test)
5-min walking test was used to evaluate the functional status of the patients.
Measured: Pre-treatment assessment.
Evaluation of Functional Status (5-min walking test)
5-min walking test was used to evaluate the functional status of the patients.
Measured: After 4 weeks of treatment (Post-treatment assessment).
Evaluation of Functional Status (5-min walking test)
5-min walking test was used to evaluate the functional status of the patients.
Measured: 2nd month post-treatment assessment.
Evaluation of Normal Joint ROM
Goniometer was used to evaluate the normal joint ROM of the patients.
Measured: Pre-treatment assessment.
Evaluation of Normal Joint ROM
Goniometer was used to evaluate the normal joint ROM of the patients.
Measured: After 4 weeks of treatment (Post-treatment assessment).
Evaluation of Normal Joint ROM
Goniometer was used to evaluate the normal joint ROM of the patients.
Measured: 2nd month post-treatment assessment.
Evaluation of Quality of Life
Short Form-36 was used to evaluate the quality of life of the patients.
Measured: Pre-treatment assessment.
Evaluation of Quality of Life
Short Form-36 was used to evaluate the quality of life of the patients.
Measured: After 4 weeks of treatment (Post-treatment assessment).
Evaluation of Quality of Life
Short Form-36 was used to evaluate the quality of life of the patients.
Measured: 2nd month post-treatment assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Nov 2017
- Primary completion1 Dec 2018
- Study completion31 Dec 2018
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
- 40 participants (actual)
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
- NCT06529926
- Sponsor's protocol ID
- ÜSAME TAŞ-004
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. 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" in Individuals With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT06529926
- Acronym / sponsor ID
- ÜSAME TAŞ-004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 Jul 2024 (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. The aim of this study was to investigate the effects of the IASTM technique on individuals of different ages diagnosed with LDH.
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: ObservationalTreated with classical physiotherapy (Hotpack+TENS+Ultrasound) program. A 20-minute hotpack was applied to the lumbar area. TENS and ultrasound were applied as electrotherapy agents. The TENS application was made with the Chattanooga Intelect Advanced Combo device. Conventional tens was applied at a frequency of 100 Hz for 20 min with a current of 100 μs. The ultrasound application was made with the Chattanooga Intelect Advanced Combo device. Lumbar area was administered at a dose of 1 MHz, 1.5 W/cm² using a 5 cm diameter cap for 6 min. In the first session, the physiotherapist had the patient explain the exercises (posterior pelvic tilt exercise, hip flexors stretching exercise, lumbar extensors stretching exercise, abdominal muscle strengthening exercise, SLR exercise, pelvic elevation exercise, cat-camel exercise and lumbar extensor strengthening exercise). Afterwards, patients were advised to rest for 1 minute between exercises, 1 time a day and for 4 weeks, 5 days a week. |
| IASTM Treatment Group | Experimental | Other: IASTM Technique ApplicationIASTM application was applied at an angle of 45° in a direction parallel to the muscle fibers for about 20 seconds. Immediately afterwards, a total of 40 seconds of treatment time was applied by treating the muscle fibers at a 45° angle with the instrument for an additional 20 seconds in a direction perpendicular to them. In other words, for each area (paraspinal muscles, gluteus maximus and gluteus medius muscles, hamstrings), a total of 2 minutes was applied to the right and left sides separately for 40x3 seconds. Paraspinal muscles were treated from caudal to cranium, gluteal muscles from proximal to distal and hamstring muscles from popliteal fossa to gluteal line. Stretching was provided by exercises applied to the control group. After the cold application, IASTM application was made, the cold-pack was applied to each area for 5 minutes. (The application was performed by a trained and experienced physiotherapist and with a stainless steel gua sha device). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals have been diagnosed with LDH,
- Their pain is 3 and above according to the Visual Analog Scale (VAS),
- They are between the ages of 20-60,
- Their clinical status is stable,
- They are fully cooperative,
Key exclusion criteria (6 listed)
- Individuals have psychological disorders, mental disorders, cancer and severe depression,
- Primary or metastatic spinal malignancy,
- Have been diagnosed with advanced osteoporosis,
- Have recently undergone surgical intervention or acute infection,
- Cannot or do not want to perform tests or treatment exercises,
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 |
|---|---|---|
| ObservationalOnly classical physiotherapy application for 4 weeks. | Other | Control Group |
| IASTM Technique ApplicationIASTM application for 2 sessions per week with classical physiotherapy for 4 weeks. | Other | IASTM Treatment Group |
Primary outcome
Evaluation of Pain
Time frame: Pre-treatment assessment.
Visual analog scale was used to evaluate the pain of the patients.
Evaluation of Pain
Time frame: After 4 weeks of treatment (Post-treatment assessment).
Visual analog scale was used to evaluate the pain of the patients.
Evaluation of Pain
Time frame: 2nd month post-treatment assessment.
Visual analog scale was used to evaluate the pain of the patients.
Evaluation of Functional Status (Straight leg raise test)
Time frame: Pre-treatment assessment.
Straight leg raise test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (Straight leg raise test)
Time frame: After 4 weeks of treatment (Post-treatment assessment).
Straight leg raise test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (Straight leg raise test)
Time frame: 2nd month post-treatment assessment.
Straight leg raise test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (Slump test)
Time frame: Pre-treatment assessment.
Slump test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (Slump test)
Time frame: After 4 weeks of treatment (Post-treatment assessment).
Slump test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (Slump test)
Time frame: 2nd month post-treatment assessment.
Slump test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (5-min walking test)
Time frame: Pre-treatment assessment.
5-min walking test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (5-min walking test)
Time frame: After 4 weeks of treatment (Post-treatment assessment).
5-min walking test was used to evaluate the functional status of the patients.
Evaluation of Functional Status (5-min walking test)
Time frame: 2nd month post-treatment assessment.
5-min walking test was used to evaluate the functional status of the patients.
Evaluation of Normal Joint ROM
Time frame: Pre-treatment assessment.
Goniometer was used to evaluate the normal joint ROM of the patients.
Evaluation of Normal Joint ROM
Time frame: After 4 weeks of treatment (Post-treatment assessment).
Goniometer was used to evaluate the normal joint ROM of the patients.
Evaluation of Normal Joint ROM
Time frame: 2nd month post-treatment assessment.
Goniometer was used to evaluate the normal joint ROM of the patients.
Evaluation of Quality of Life
Time frame: Pre-treatment assessment.
Short Form-36 was used to evaluate the quality of life of the patients.
Evaluation of Quality of Life
Time frame: After 4 weeks of treatment (Post-treatment assessment).
Short Form-36 was used to evaluate the quality of life of the patients.
Evaluation of Quality of Life
Time frame: 2nd month post-treatment assessment.
Short Form-36 was used to evaluate the quality of life of the patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- 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 Treatment, 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Pain (time frame: Pre-treatment assessment.). The study lists 18 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 31 Jul 2024.