Muscle StiffnessNCT07822594
Immediate Effects of Two IASTM Tools on Lower-Leg Tissue Stiffness and Ankle Mobility
A study testing Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool and Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
Trial summary
This randomized controlled trial will investigate the immediate effects of instrument-assisted soft tissue mobilization (IASTM) performed with two different commercially available tools on posterior lower-leg tissue stiffness and ankle dorsiflexion range of motion in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Stiffness
- What is being tested?
- Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool and Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 40 years
- Healthy volunteer
- Willing and able to provide written informed consent
Who cannot join
- Current or previous lower-limb injury
- Neuromuscular disorder
- Neurological disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University of Primorska, Faculty of Health Sciences, Izola
Izola, Urban Municipality of Koper, 6310
Ziga Kozinc, PhD, 040161503, ziga.kozinc@fvz.upr.si
About this study
Official title: Acute Effects of Instrument-Assisted Soft Tissue Mobilization Using Lower-Cost and Higher-Cost Tools Lower-Leg Tissue Stiffness and Ankle Dorsiflexion Range of Motion in Healthy Adults: A Randomized Controlled Trial
This randomized controlled trial will investigate the immediate effects of instrument-assisted soft tissue mobilization (IASTM) performed with two different commercially available tools on posterior lower-leg tissue stiffness and ankle dorsiflexion range of motion in healthy young adults. Participants will be randomly allocated to one of three parallel groups: IASTM using a higher-cost tool, IASTM using a lower-cost tool, or passive rest without IASTM.
Tissue stiffness at predefined posterior lower-leg sites and ankle dorsiflexion range of motion will be assessed before and immediately after the intervention or equivalent rest period. A single lower limb will be assessed in each participant. Participants receiving IASTM will additionally rate the pleasantness of the intervention and their perceived relaxation after the intervention.
The study will determine whether IASTM produces immediate changes in tissue stiffness and ankle dorsiflexion compared with passive rest and whether these effects differ between the two IASTM tools.
Read the detailed description
Healthy adults aged 18 to 30 years will be randomly allocated to one of three parallel groups: higher-cost IASTM, lower-cost IASTM, or passive control. Only one lower limb will be assessed in each participant; the contralateral limb will not serve as a control.
Before and immediately after the intervention or control period, tissue stiffness will be assessed using MyotonPRO (Myoton AS, Tallinn, Estonia) at four predefined locations: the medial gastrocnemius, lateral gastrocnemius, soleus, and Achilles tendon. Gastrocnemius measurement locations will be identified at one-third of the respective anatomical reference distances described in the protocol. The soleus measurement will be performed medially at one-third of the distance from the medial malleolus toward the medial femoral condyle. The Achilles tendon will be assessed 2 cm proximal to the calcaneus. Two consecutive measurements will be obtained at each site at each assessment, and their mean will be used for analysis.
Ankle dorsiflexion range of motion will be assessed using a digital inclinometer positioned on the lateral aspect of the lower leg during a weight-bearing lunge performed while maintaining the assessed knee extended and the heel in contact with the floor.
Participants in either IASTM group will receive a six-minute standardized treatment of the posterior lower-leg region. The first minute will consist of familiarization with the instrument, desensitization, and application of IASTM cream. This will be followed by five minutes of treatment using long gliding strokes along the direction of the muscle fibers, with the instrument held at approximately a 45-degree angle. Treatment intensity will be adjusted to produce slight pain or moderate discomfort. The treatment protocol will be identical between IASTM groups except for the tool used.
Participants allocated to the control group will rest passively for an equivalent six-minute period without receiving IASTM. Participants receiving IASTM will rate intervention pleasantness and perceived relaxation immediately after treatment using 0-to-10 numerical rating scales.
- Conditions
- Muscle Stiffness
- Being tested
- Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool, Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool
- Keywords
- instrument-assisted soft tissue mobilization, soft tissue mobilization, muscle stiffness, ankle dorsiflexion, MyotonPRO, gastrocnemius, soleus, Achilles tendon, range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost ToolProcedure or surgery
A six-minute standardized IASTM intervention applied to the posterior lower-leg region using a higher-cost IASTM tool. The first minute consists of familiarization, desensitization, and application of IASTM cream, followed by five minutes of long gliding strokes along the direction of the muscle fibers. The instrument is held at approximately 45 degrees and treatment intensity is adjusted to slight pain or moderate discomfort.
Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost ToolProcedure or surgery
The same six-minute standardized IASTM intervention as in the higher-cost tool condition, performed using a lower-cost IASTM tool. Treatment duration, treated region, stroke direction, instrument angle, and target intensity are standardized between the two IASTM interventions.
| Study group | Role | What they receive |
|---|---|---|
| Higher-Cost IASTM | Experimental | Participants will receive a standardized six-minute IASTM intervention to the posterior lower-leg region using the higher-cost IASTM tool. The first minute will include familiarization, desensitization, and application of IASTM cream, followed by five minutes of standardized treatment. Receives: Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool |
| Lower-Cost IASTM | Active comparator | Participants will receive the same standardized six-minute IASTM intervention to the posterior lower-leg region using the lower-cost IASTM tool. Treatment duration, technique, instrument angle, treated region, and intensity will be matched to the higher-cost IASTM group. Receives: Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool |
| Passive Control | No intervention | Participants will rest passively for six minutes without receiving IASTM. Measurements will be performed before and immediately after the rest period using the same procedures as in the intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Medial Gastrocnemius Stiffness
Tissue stiffness will be measured using MyotonPRO and expressed in N/m. Two consecutive measurements will be obtained at each assessment and averaged.
Measured: Baseline and immediately after the 6-minute intervention or rest period
Change From Baseline in Lateral Gastrocnemius Stiffness
Tissue stiffness will be measured using MyotonPRO and expressed in N/m. Two consecutive measurements will be obtained at each assessment and averaged.
Measured: Baseline and immediately after the 6-minute intervention or rest period
Change From Baseline in Soleus Stiffness
Tissue stiffness will be measured using MyotonPRO and expressed in N/m. The measurement site will be located medially at one-third of the distance from the medial malleolus toward the medial femoral condyle. Two consecutive measurements will be obtained and averaged.
Measured: Baseline and immediately after the 6-minute intervention or rest period
Change From Baseline in Achilles Tendon Stiffness
Achilles tendon stiffness will be measured using MyotonPRO and expressed in N/m at a predefined site 2 cm proximal to the calcaneus. Two consecutive measurements will be obtained and averaged.
Measured: Baseline and immediately after the 6-minute intervention or rest period
Change From Baseline in Ankle Dorsiflexion Range of Motion
Ankle dorsiflexion range of motion will be measured in degrees using a digital inclinometer positioned on the lateral aspect of the lower leg during a weight-bearing lunge with the assessed knee maintained in extension and the heel in contact with the floor.
Measured: Baseline and immediately after the 6-minute intervention or rest period
Secondary outcomes (2)
Perceived Pleasantness of IASTM
Participants receiving IASTM will rate the pleasantness of the intervention on an 11-point numerical rating scale ranging from 0 to 10, with 0 representing the lowest possible pleasantness and 10 representing the highest possible pleasantness.
Measured: Immediately after the 6-minute IASTM intervention
Perceived Relaxation After IASTM
Participants receiving IASTM will rate their perceived relaxation after the intervention on an 11-point numerical rating scale ranging from 0 to 10, with 0 representing the lowest possible relaxation and 10 representing the highest possible relaxation.
Measured: Immediately after the 6-minute IASTM intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StiffnessStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of three parallel groups: higher-cost IASTM, lower-cost IASTM, or passive rest. One lower limb per participant will be assessed before and immediately after the intervention or equivalent control period.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Žiga Kozinc, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822594
- Sponsor's protocol ID
- UPFVZ-IASTM-2026
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be made available upon reasonable request. After publication of scientific manuscript, the data will also be uploaded to a trusted repository (Zenodo.org).
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Instrument-Assisted Soft Tissue Mobilization Using Lower-Cost and Higher-Cost Tools Lower-Leg Tissue Stiffness and Ankle Dorsiflexion Range of Motion in Healthy Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07822594
- Acronym / sponsor ID
- UPFVZ-IASTM-2026
- Conditions
- Muscle Stiffness
- Keywords
- instrument-assisted soft tissue mobilization, soft tissue mobilization, muscle stiffness, ankle dorsiflexion, MyotonPRO, gastrocnemius, soleus, Achilles tendon
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 16 Sep 2026 (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.
This randomized controlled trial will investigate the immediate effects of instrument-assisted soft tissue mobilization (IASTM) performed with two different commercially available tools on posterior lower-leg tissue stiffness and ankle dorsiflexion range of motion in healthy young adults. Participants will be randomly allocated to one of three parallel groups: IASTM using a higher-cost tool, IASTM using a lower-cost tool, or passive rest without IASTM.
Tissue stiffness at predefined posterior lower-leg sites and ankle dorsiflexion range of motion will be assessed before and immediately after the intervention or equivalent rest period. A single lower limb will be assessed in each participant. Participants receiving IASTM will additionally rate the pleasantness of the intervention and their perceived relaxation after the intervention.
The study will determine whether IASTM produces immediate changes in tissue stiffness and ankle dorsiflexion compared with passive rest and whether these effects differ between the two IASTM tools.
Detailed description
Healthy adults aged 18 to 30 years will be randomly allocated to one of three parallel groups: higher-cost IASTM, lower-cost IASTM, or passive control. Only one lower limb will be assessed in each participant; the contralateral limb will not serve as a control.
Before and immediately after the intervention or control period, tissue stiffness will be assessed using MyotonPRO (Myoton AS, Tallinn, Estonia) at four predefined locations: the medial gastrocnemius, lateral gastrocnemius, soleus, and Achilles tendon. Gastrocnemius measurement locations will be identified at one-third of the respective anatomical reference distances described in the protocol. The soleus measurement will be performed medially at one-third of the distance from the medial malleolus toward the medial femoral condyle. The Achilles tendon will be assessed 2 cm proximal to the calcaneus. Two consecutive measurements will be obtained at each site at each assessment, and their mean will be used for analysis.
Ankle dorsiflexion range of motion will be assessed using a digital inclinometer positioned on the lateral aspect of the lower leg during a weight-bearing lunge performed while maintaining the assessed knee extended and the heel in contact with the floor.
Participants in either IASTM group will receive a six-minute standardized treatment of the posterior lower-leg region. The first minute will consist of familiarization with the instrument, desensitization, and application of IASTM cream. This will be followed by five minutes of treatment using long gliding strokes along the direction of the muscle fibers, with the instrument held at approximately a 45-degree angle. Treatment intensity will be adjusted to produce slight pain or moderate discomfort. The treatment protocol will be identical between IASTM groups except for the tool used.
Participants allocated to the control group will rest passively for an equivalent six-minute period without receiving IASTM. Participants receiving IASTM will rate intervention pleasantness and perceived relaxation immediately after treatment using 0-to-10 numerical rating scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated to one of three parallel groups: higher-cost IASTM, lower-cost IASTM, or passive rest. One lower limb per participant will be assessed before and immediately after the intervention or equivalent control period.
| Arm | Type | Receives |
|---|---|---|
| Higher-Cost IASTM | Experimental | Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost ToolParticipants will receive a standardized six-minute IASTM intervention to the posterior lower-leg region using the higher-cost IASTM tool. The first minute will include familiarization, desensitization, and application of IASTM cream, followed by five minutes of standardized treatment. |
| Lower-Cost IASTM | Active comparator | Procedure: Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost ToolParticipants will receive the same standardized six-minute IASTM intervention to the posterior lower-leg region using the lower-cost IASTM tool. Treatment duration, technique, instrument angle, treated region, and intensity will be matched to the higher-cost IASTM group. |
| Passive Control | No intervention | –Participants will rest passively for six minutes without receiving IASTM. Measurements will be performed before and immediately after the rest period using the same procedures as in the intervention groups. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 40 years
- Healthy volunteer
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Current or previous lower-limb injury
- Neuromuscular disorder
- Neurological disorder
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 |
|---|---|---|
| Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost ToolA six-minute standardized IASTM intervention applied to the posterior lower-leg region using a higher-cost IASTM tool. The first minute consists of familiarization, desensitization, and application of IASTM cream, followed by five minutes of long gliding strokes along the direction of the muscle fibers. The instrument is held at approximately 45 degrees and treatment intensity is adjusted to slight pain or moderate discomfort. | Procedure or surgery | Higher-Cost IASTM |
| Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost ToolThe same six-minute standardized IASTM intervention as in the higher-cost tool condition, performed using a lower-cost IASTM tool. Treatment duration, treated region, stroke direction, instrument angle, and target intensity are standardized between the two IASTM interventions. | Procedure or surgery | Lower-Cost IASTM |
Primary outcome
Change From Baseline in Medial Gastrocnemius Stiffness
Time frame: Baseline and immediately after the 6-minute intervention or rest period
Tissue stiffness will be measured using MyotonPRO and expressed in N/m. Two consecutive measurements will be obtained at each assessment and averaged.
Change From Baseline in Lateral Gastrocnemius Stiffness
Time frame: Baseline and immediately after the 6-minute intervention or rest period
Tissue stiffness will be measured using MyotonPRO and expressed in N/m. Two consecutive measurements will be obtained at each assessment and averaged.
Change From Baseline in Soleus Stiffness
Time frame: Baseline and immediately after the 6-minute intervention or rest period
Tissue stiffness will be measured using MyotonPRO and expressed in N/m. The measurement site will be located medially at one-third of the distance from the medial malleolus toward the medial femoral condyle. Two consecutive measurements will be obtained and averaged.
Change From Baseline in Achilles Tendon Stiffness
Time frame: Baseline and immediately after the 6-minute intervention or rest period
Achilles tendon stiffness will be measured using MyotonPRO and expressed in N/m at a predefined site 2 cm proximal to the calcaneus. Two consecutive measurements will be obtained and averaged.
Change From Baseline in Ankle Dorsiflexion Range of Motion
Time frame: Baseline and immediately after the 6-minute intervention or rest period
Ankle dorsiflexion range of motion will be measured in degrees using a digital inclinometer positioned on the lateral aspect of the lower leg during a weight-bearing lunge with the assessed knee maintained in extension and the heel in contact with the floor.
2 secondary outcomes
Perceived Pleasantness of IASTM
Time frame: Immediately after the 6-minute IASTM intervention
Perceived Relaxation After IASTM
Time frame: Immediately after the 6-minute IASTM intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be made available upon reasonable request. After publication of scientific manuscript, the data will also be uploaded to a trusted repository (Zenodo.org).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-Assisted Soft Tissue Mobilization Using a Higher-Cost Tool and Instrument-Assisted Soft Tissue Mobilization Using a Lower-Cost Tool in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Sep 2026. 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Žiga Kozinc, PhD (040161503 ext. +386, ziga.kozinc@s2p.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Medial Gastrocnemius Stiffness (time frame: Baseline and immediately after the 6-minute intervention or rest period). The study lists 5 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 17 Sep 2026.