HealthyNCT07075172
Does Instrument-assisted Mobilization Influence Healthy, Short Achilles Tendons?
A study testing Instrumented-assisted soft tissue mobilization in people with Healthy and Achilles Tendon Length and Thickness, run by Indiana University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if instrumented-assisted soft tissue mobilization (i.e., massage using specialized metal instruments) of the lower leg and Achilles tendon region changes the properties of the tendon and the range of ankle dorsiflexion (i.e., the ability to bring the foot and toes back… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Achilles Tendon Length and Thickness
- What is being tested?
- Instrumented-assisted soft tissue mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2013to 16 Oct 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The distance from the tip of the great toe to the wall during the weightbearing lunge test is <90 mm bilaterally with ≤15 mm asymmetry
- A stretch sensation is reported in the region of the Achilles tendon during the weightbearing lunge test
Who cannot join
- A history of Achilles tendon injury, pain, rupture or surgery
- Current pain in the heel, foot or ankle
- Surgery in the past 12 months to the foot, heel or ankle
- A sensation other than a stretch within the Achilles tendon region during the weightbearing lunge test (e.g. compression/pinching in the vicinity of the anterior talocrural joint or a more vague, deeper stretch within the vicinity of the posterior talocrural joint).
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Indianapolis
Indianapolis, Indiana, 46202
About this study
Official title: Instrument Assisted Soft Tissue Mobilization Alters the Material and Mechanical Properties of Healthy, Shortened Achilles Tendons: a Within-subject Randomized Controlled Study
The goal of this clinical trial is to learn if instrumented-assisted soft tissue mobilization (i.e., massage using specialized metal instruments) of the lower leg and Achilles tendon region changes the properties of the tendon and the range of ankle dorsiflexion (i.e., the ability to bring the foot and toes back towards the head).
One lower leg and Achilles tendon in each participant will be treated with instrumented-assisted soft tissue mobilization for 7 minutes during 8 treatment sessions over a 4-week period. The other lower leg and Achilles tendon will not be treated and be assessed as the non-treated control leg.
Read the detailed description
Tendons play a critical role in transferring muscle-generated forces to the skeleton for locomotion, but they are not solely force conveyors. Tendons also function as both mechanical buffers and power amplifiers. In their buffering role, tendons delay and slow muscle fascicle lengthening to dissipate energy during rapid negative work (i.e. eccentric contractions). However, it is in their role as power amplifiers that tendons have received most attention. Acting in a spring-like manner, tendons store elastic strain energy when stretched and return it when released to reduce the energy cost of motion. The amount of energy stored depends on a tendon's mechanical properties and, in particular, its stiffness.
Stiffness represents the ability of a structure to resist deformation and is dependent upon both the quality of material present (i.e. amount and type) and how it is arranged (i.e. structure). Stiffer tendons may promote an improved ability to transmit muscle-generated forces resulting in improved performance. A stiffer tendon may also protect against injury. Tendons experience failure in a relatively set strain (i.e. elongation) range. A stiffer tendon experiences less strain per unit of applied force and, thus, can withstand greater load before reaching damage-inducing strains.
It is now accepted tendons adapt their stiffness (among other properties) to their environment. Tendon stiffness declines with disuse, pathology (i.e. tendinopathy) and aging. Conversely, systematic reviews have demonstrated tendon stiffness increases in response to heightened levels of physical activity, with a preference toward high intensity loads (i.e. >70% maximum voluntary contraction or repetition maximum). However, beyond physical activity there are limited clinically available modalities to positively influence tendon stiffness. For instance, vibration and stretching interventions have not been shown to impact tendon stiffness or even cause it to decline.
A modality that may modulate tendon stiffness is instrument assisted soft tissue mobilization (IASTM). IASTM is a popular alternative to traditional manual therapy techniques and involves the use of specialized hard tools to apply controlled, localized mechanical loads to soft connective tissues. Initial preclinical animal studies reported IASTM altered fibroblast recruitment and activation after chemically-induced tendon injury, and improved tissue perfusion and mechanical recovery following surgically-induced ligament injury. Clinically, there is emerging but limited and low-quality evidence of the efficacy of IASTM in improving range of motion, pain and patient-reported outcomes. With regards to tissue stiffness, studies have reported single IASTM treatments targeting muscle to have no effect on musculotendinous shear modulus or stiffness, and to reduce or have no effect on passively assessed joint stiffness. To our knowledge, no study has reported a beneficial effect of IASTM on tendon mechanical and material properties, with Ikeda et al. reporting that IASTM self-administered over 6-weeks to the posterior lower leg had no impact on Achilles tendon (AT) shear modulus assessed using shear wave elastography.
The primary aim of the current study is to explore the effect of IASTM administered to the posterior lower leg and Achilles tendon twice per week for 4 weeks on the material and mechanical properties of the tendon in healthy subjects with reduced tendon length. A secondary aim is to investigate the impact of IASTM applied to the AT on range of ankle dorsiflexion, assessed using the weight bearing lunge ('lunge') test. The study will implement a within-subject controlled design wherein one leg received IASTM and the contralateral leg served as a non-IASTM treated internal control. Both sides will be equally exposed to warm-up and stretching activities within each treatment session.
- Conditions
- Healthy, Achilles Tendon Length and Thickness
- Being tested
- Instrumented-assisted soft tissue mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented-assisted soft tissue mobilizationOther
Instrumented-assisted soft tissue mobilization of the posterior leg and Achilles tendon region
| Study group | Role | What they receive |
|---|---|---|
| IASTM treated | Experimental | Leg treated with instrument-assisted soft tissue mobilization Receives: Other: Instrumented-assisted soft tissue mobilization |
| Non-treated | No intervention | Non-treated leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the stiffness of the Achilles tendon measured using ultrasound
Participants will push their foot against a force measuring platform. At the same time, an ultrasound will be used to image their Achilles tendon. How much force they generated will be divided by how far the tendon stretches to indicate stiffness in newtons per millimeter (N/mm)
Measured: From enrollment until 6 days after the end of treatment at 4 weeks
Change in the modulus of the Achilles tendon measured using ultrasound
Participants will push their foot against a force measuring platform. At the same time, an ultrasound will be used to image their Achilles tendon. How much force they generated will be divided by how far the tendon stretches to indicate stiffness in newtons per millimeter (N/mm). The stiffness will be divided by the cross sectional area of the tendon to indicate modulus in megaPascals (MPa).
Measured: From enrollment until 6 days after the end of treatment at 4 weeks
Secondary outcomes (1)
Range of motion of ankle dorsiflexion
Assessed using the weightbearing lunge test
Measured: From enrollment until 6 days after the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start3 Oct 2013
- Primary completion16 Oct 2014
- Study completion16 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Model description
- Within-subject controlled study. One side of the body is treated with the other side being an internal non-treated control site.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Warden, Indiana University
- Investigators
- Stuart Warden, Principal investigator, Indiana University Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075172
- Sponsor's protocol ID
- BaylissRCT1
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be available from the study investigators upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument Assisted Soft Tissue Mobilization Alters the Material and Mechanical Properties of Healthy, Shortened Achilles Tendons: a Within-subject Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07075172
- Acronym / sponsor ID
- BaylissRCT1
- Conditions
- Healthy, Achilles Tendon Length and Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 3 Oct 2013 (actual)
- Primary completion
- 16 Oct 2014 (actual)
- Study completion
- 16 Oct 2014 (actual)
- First posted
- 20 Jul 2025 (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.
The goal of this clinical trial is to learn if instrumented-assisted soft tissue mobilization (i.e., massage using specialized metal instruments) of the lower leg and Achilles tendon region changes the properties of the tendon and the range of ankle dorsiflexion (i.e., the ability to bring the foot and toes back towards the head).
One lower leg and Achilles tendon in each participant will be treated with instrumented-assisted soft tissue mobilization for 7 minutes during 8 treatment sessions over a 4-week period. The other lower leg and Achilles tendon will not be treated and be assessed as the non-treated control leg.
Detailed description
Tendons play a critical role in transferring muscle-generated forces to the skeleton for locomotion, but they are not solely force conveyors. Tendons also function as both mechanical buffers and power amplifiers. In their buffering role, tendons delay and slow muscle fascicle lengthening to dissipate energy during rapid negative work (i.e. eccentric contractions). However, it is in their role as power amplifiers that tendons have received most attention. Acting in a spring-like manner, tendons store elastic strain energy when stretched and return it when released to reduce the energy cost of motion. The amount of energy stored depends on a tendon's mechanical properties and, in particular, its stiffness.
Stiffness represents the ability of a structure to resist deformation and is dependent upon both the quality of material present (i.e. amount and type) and how it is arranged (i.e. structure). Stiffer tendons may promote an improved ability to transmit muscle-generated forces resulting in improved performance. A stiffer tendon may also protect against injury. Tendons experience failure in a relatively set strain (i.e. elongation) range. A stiffer tendon experiences less strain per unit of applied force and, thus, can withstand greater load before reaching damage-inducing strains.
It is now accepted tendons adapt their stiffness (among other properties) to their environment. Tendon stiffness declines with disuse, pathology (i.e. tendinopathy) and aging. Conversely, systematic reviews have demonstrated tendon stiffness increases in response to heightened levels of physical activity, with a preference toward high intensity loads (i.e. >70% maximum voluntary contraction or repetition maximum). However, beyond physical activity there are limited clinically available modalities to positively influence tendon stiffness. For instance, vibration and stretching interventions have not been shown to impact tendon stiffness or even cause it to decline.
A modality that may modulate tendon stiffness is instrument assisted soft tissue mobilization (IASTM). IASTM is a popular alternative to traditional manual therapy techniques and involves the use of specialized hard tools to apply controlled, localized mechanical loads to soft connective tissues. Initial preclinical animal studies reported IASTM altered fibroblast recruitment and activation after chemically-induced tendon injury, and improved tissue perfusion and mechanical recovery following surgically-induced ligament injury. Clinically, there is emerging but limited and low-quality evidence of the efficacy of IASTM in improving range of motion, pain and patient-reported outcomes. With regards to tissue stiffness, studies have reported single IASTM treatments targeting muscle to have no effect on musculotendinous shear modulus or stiffness, and to reduce or have no effect on passively assessed joint stiffness. To our knowledge, no study has reported a beneficial effect of IASTM on tendon mechanical and material properties, with Ikeda et al. reporting that IASTM self-administered over 6-weeks to the posterior lower leg had no impact on Achilles tendon (AT) shear modulus assessed using shear wave elastography.
The primary aim of the current study is to explore the effect of IASTM administered to the posterior lower leg and Achilles tendon twice per week for 4 weeks on the material and mechanical properties of the tendon in healthy subjects with reduced tendon length. A secondary aim is to investigate the impact of IASTM applied to the AT on range of ankle dorsiflexion, assessed using the weight bearing lunge ('lunge') test. The study will implement a within-subject controlled design wherein one leg received IASTM and the contralateral leg served as a non-IASTM treated internal control. Both sides will be equally exposed to warm-up and stretching activities within each treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject controlled study. One side of the body is treated with the other side being an internal non-treated control site.
| Arm | Type | Receives |
|---|---|---|
| IASTM treated | Experimental | Other: Instrumented-assisted soft tissue mobilizationLeg treated with instrument-assisted soft tissue mobilization |
| Non-treated | No intervention | –Non-treated leg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The distance from the tip of the great toe to the wall during the weightbearing lunge test is <90 mm bilaterally with ≤15 mm asymmetry
- A stretch sensation is reported in the region of the Achilles tendon during the weightbearing lunge test
Key exclusion criteria (4 listed)
- A history of Achilles tendon injury, pain, rupture or surgery
- Current pain in the heel, foot or ankle
- Surgery in the past 12 months to the foot, heel or ankle
- A sensation other than a stretch within the Achilles tendon region during the weightbearing lunge test (e.g. compression/pinching in the vicinity of the anterior talocrural joint or a more vague, deeper stretch within the vicinity of the posterior talocrural joint).
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 |
|---|---|---|
| Instrumented-assisted soft tissue mobilizationInstrumented-assisted soft tissue mobilization of the posterior leg and Achilles tendon region | Other | IASTM treated |
Primary outcome
Change in the stiffness of the Achilles tendon measured using ultrasound
Time frame: From enrollment until 6 days after the end of treatment at 4 weeks
Participants will push their foot against a force measuring platform. At the same time, an ultrasound will be used to image their Achilles tendon. How much force they generated will be divided by how far the tendon stretches to indicate stiffness in newtons per millimeter (N/mm)
Change in the modulus of the Achilles tendon measured using ultrasound
Time frame: From enrollment until 6 days after the end of treatment at 4 weeks
Participants will push their foot against a force measuring platform. At the same time, an ultrasound will be used to image their Achilles tendon. How much force they generated will be divided by how far the tendon stretches to indicate stiffness in newtons per millimeter (N/mm). The stiffness will be divided by the cross sectional area of the tendon to indicate modulus in megaPascals (MPa).
1 secondary outcome
Range of motion of ankle dorsiflexion
Time frame: From enrollment until 6 days after the end of treatment at 4 weeks
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 20 Jul 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be available from the study investigators upon reasonable request.
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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.
Stuart Warden principal investigator
Indiana University Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumented-assisted soft tissue mobilization in people with Healthy and Achilles Tendon Length and Thickness, run by Indiana University at 1 site in United States.
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 2 inclusion and 4 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 20 Jul 2025. 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 United States. 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?
Change in the stiffness of the Achilles tendon measured using ultrasound (time frame: From enrollment until 6 days after the end of treatment at 4 weeks). The study lists 2 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 20 Jul 2025.