AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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.

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 groups in NCT07075172
Study groupRoleWhat they receive
IASTM treatedExperimentalLeg treated with instrument-assisted soft tissue mobilization
Receives: Other: Instrumented-assisted soft tissue mobilization
Non-treatedNo interventionNon-treated leg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  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.

  1. First posted20 Jul 2025
  2. Study start3 Oct 2013
  3. Primary completion16 Oct 2014
  4. Study completion16 Oct 2014

Resources

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)
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.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in