Muscle ToneFRTONENCT07564206
Foam Roller Compared to Massage on Reducing Calf Muscle Tone in Healthy Subjects
A study testing Foam roller and Massage in people with Muscle Tone and Healthy Adult, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Objective: This study aims to compare the effects of two techniques-foam rolling (FR) and therapeutic massage-on reducing the muscle tone in the calf muscles (gastrocnemius and soleus) of healthy individuals. Methods: A randomized, controlled crossover design was used with 40 healthy participants (aged 18-45). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone, Healthy Adult
- What is being tested?
- Foam roller and Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2026to 5 Jun 2026
- 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
- Age: Participants aged between 18 and 45 years.
- Health Status: Healthy individuals with no prior musculoskeletal conditions in the lower limbs.
- Pain-Free: Participants should not have had pain in the gastrocnemius or Achilles tendon in the last 3 months.
- Willingness: Participants must provide informed consent and be available for the intervention and necessary evaluations.
Who cannot join
- Musculoskeletal Conditions: Individuals with any pathologies in the calf muscles (gastrocnemius, soleus) or Achilles tendon.
- Vascular or Neurological Issues: Participants with vascular diseases or neurological disorders that may interfere with the interventions or muscle response.
- Skin Conditions: Exclusion of participants with skin alterations, infections, or open wounds in the area of intervention.
- Pregnancy: Women who are pregnant.
- Sensitivity Issues: Participants with altered sensitivity in the lower limbs or any condition that may affect the response to the techniques.
- Non-Compliance: Individuals who do not provide informed consent or are not available for the required evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Foam Roller Compared to Massage on Reducing Calf Muscle Tone in Healthy Subject
Objective: This study aims to compare the effects of two techniques-foam rolling (FR) and therapeutic massage-on reducing the muscle tone in the calf muscles (gastrocnemius and soleus) of healthy individuals.
Methods: A randomized, controlled crossover design was used with 40 healthy participants (aged 18-45). Participants were randomly assigned to either a foam roller or a therapeutic massage group. The interventions were applied to the dominant leg, and muscle tone was measured pre- and post-intervention using a MyotonPro device. The primary outcome was muscle tone (Hz), and secondary outcomes included muscle stiffness (N/m) and elasticity (D [log]).
Read more
Results: The study will assess the effectiveness of each intervention on muscle tone, stiffness, and elasticity. It aims to determine whether foam rolling is as effective or superior to traditional massage in reducing calf muscle tone.
Conclusion: This research will contribute to understanding the efficacy of foam rolling as a self-administered technique for muscle tone reduction and its potential application in clinical and athletic settings
- Conditions
- Muscle Tone, Healthy Adult
- Being tested
- Foam roller, Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam rollerOther
The foam roller is used for self-myofascial release (SMR) to reduce muscle tightness and improve flexibility. In this study, participants will use the foam roller on their dominant calf muscles, rolling it up and down at a controlled pace (30 rolls per minute). The pressure applied should be moderate, staying within a pain tolerance of 6/10 on the Visual Analogue Scale (VAS).
The technique is repeated three times, with a one-minute rest between sets. The goal is to enhance muscle relaxation and reduce muscle tone
MassageOther
The therapeutic massage used in this study involves manual techniques to reduce muscle tone and improve flexibility in the calf muscles. It includes:
- Deep Gliding Stroke: Sliding from the upper to the lower part of the calf to relax the muscles.
- Soleus Compression: Applying pressure to the soleus muscle with the hands to release tension.
- Calf Compression: Applying pressure to specific points on the calf to alleviate stiffness.
Each technique lasts for 2 minutes, with a total intervention time of 8 minutes per participant. The goal is to reduce muscle tone and enhance relaxation
| Study group | Role | What they receive |
|---|---|---|
| Foam roller | Experimental | A foam roller is a cylindrical tool used for self-myofascial release (SMR), a technique that involves applying pressure to muscle groups to alleviate muscle tightness, improve flexibility, and reduce soreness. It is widely used in physical therapy, sports rehabilitation, and fitness routines. The foam roller is typically made from a dense foam material that allows for controlled compression of the muscles and fascia during rolling movements.
In the study, participants will use a foam roller to target the calf muscles (gastrocnemius and soleus) on their dominant leg. The foam roller technique consists of rolling the device along the targeted muscle areas in both directions-cranial to caudal (from the top to the bottom) and vice versa-at a slow, controlled pace (30 rolls per minute). Receives: Other: Foam roller |
| Massage | Active comparator | The therapeutic massage used in this study involves manual techniques to reduce muscle tone and improve flexibility in the calf muscles. It includes:
1. Deep Gliding Stroke: Sliding from the upper to the lower part of the calf to relax the muscles.
2. Soleus Compression: Applying pressure to the soleus muscle with the hands to release tension.
3. Calf Compression: Applying pressure to specific points on the calf to alleviate stiffness.
Each technique lasts for 2 minutes, with a total intervention time of 8 minutes per participant. The goal is to reduce muscle tone and enhance relaxation Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone
Description: Muscle tone refers to the continuous and passive tension in a muscle at rest, measured by its resistance to passive stretching. It is quantified in Hertz (Hz), indicating the frequency of oscillation when the muscle is in a relaxed state.
Measured: Pre and post intervention (immediately post foam roller procedure)
Secondary outcomes (2)
Muscle stiffness
Description: Muscle stiffness is the resistance a muscle provides when stretched. It is measured in Newtons per meter (N/m) and reflects how much force is needed to deform the muscle. Higher stiffness indicates less flexibility.
Measured: Pre intervention and post intervention (immediately after the foam roller procedure)
Muscle elasticity
Description: Elasticity refers to a muscle's ability to return to its original shape after being stretched. It is measured using a logarithmic scale (D [log]), representing the rate of decrease in oscillation amplitude after a mechanical disturbance.
Measured: pre and post intervention (immediately after the interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start15 May 2026
- Primary completion1 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle ToneStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Romero Morales, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564206
- Sponsor's protocol ID
- CI-2026-338
- Acronym
- FRTONE
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perez-Bellmunt A, Labata-Lezaun N, Llurda-Almuzara L, Rodriguez-Sanz J, Gonzalez-Rueda V, Bueno-Gracia E, Celik D, Lopez-de-Celis C. Effects of a Massage Protocol in Tensiomyographic and Myotonometric Proprieties. Int J Environ Res Public Health. 2021 Apr 8;18(8):3891. doi: 10.3390/ijerph18083891.
PubMed 33917668Laffaye G, Da Silva DT, Delafontaine A. Self-Myofascial Release Effect With Foam Rolling on Recovery After High-Intensity Interval Training. Front Physiol. 2019 Oct 16;10:1287. doi: 10.3389/fphys.2019.01287. eCollection 2019.
PubMed 31681002
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foam Roller Compared to Massage on Reducing Calf Muscle Tone in Healthy Subject
- ClinicalTrials.gov ID
- NCT07564206
- Acronym / sponsor ID
- FRTONE / CI-2026-338
- Conditions
- Muscle Tone, Healthy Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 4 May 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.
Objective: This study aims to compare the effects of two techniques-foam rolling (FR) and therapeutic massage-on reducing the muscle tone in the calf muscles (gastrocnemius and soleus) of healthy individuals.
Methods: A randomized, controlled crossover design was used with 40 healthy participants (aged 18-45). Participants were randomly assigned to either a foam roller or a therapeutic massage group. The interventions were applied to the dominant leg, and muscle tone was measured pre- and post-intervention using a MyotonPro device. The primary outcome was muscle tone (Hz), and secondary outcomes included muscle stiffness (N/m) and elasticity (D [log]).
Results: The study will assess the effectiveness of each intervention on muscle tone, stiffness, and elasticity. It aims to determine whether foam rolling is as effective or superior to traditional massage in reducing calf muscle tone.
Conclusion: This research will contribute to understanding the efficacy of foam rolling as a self-administered technique for muscle tone reduction and its potential application in clinical and athletic settings
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foam roller | Experimental | Other: Foam rollerA foam roller is a cylindrical tool used for self-myofascial release (SMR), a technique that involves applying pressure to muscle groups to alleviate muscle tightness, improve flexibility, and reduce soreness. It is widely used in physical therapy, sports rehabilitation, and fitness routines. The foam roller is typically made from a dense foam material that allows for controlled compression of the muscles and fascia during rolling movements. In the study, participants will use a foam roller to target the calf muscles (gastrocnemius and soleus) on their dominant leg. The foam roller technique consists of rolling the device along the targeted muscle areas in both directions-cranial to caudal (from the top to the bottom) and vice versa-at a slow, controlled pace (30 rolls per minute). |
| Massage | Active comparator | Other: MassageThe therapeutic massage used in this study involves manual techniques to reduce muscle tone and improve flexibility in the calf muscles. It includes: 1. Deep Gliding Stroke: Sliding from the upper to the lower part of the calf to relax the muscles. 2. Soleus Compression: Applying pressure to the soleus muscle with the hands to release tension. 3. Calf Compression: Applying pressure to specific points on the calf to alleviate stiffness. Each technique lasts for 2 minutes, with a total intervention time of 8 minutes per participant. The goal is to reduce muscle tone and enhance relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: Participants aged between 18 and 45 years.
- Health Status: Healthy individuals with no prior musculoskeletal conditions in the lower limbs.
- Pain-Free: Participants should not have had pain in the gastrocnemius or Achilles tendon in the last 3 months.
- Willingness: Participants must provide informed consent and be available for the intervention and necessary evaluations.
Key exclusion criteria (6 listed)
- Musculoskeletal Conditions: Individuals with any pathologies in the calf muscles (gastrocnemius, soleus) or Achilles tendon.
- Vascular or Neurological Issues: Participants with vascular diseases or neurological disorders that may interfere with the interventions or muscle response.
- Skin Conditions: Exclusion of participants with skin alterations, infections, or open wounds in the area of intervention.
- Pregnancy: Women who are pregnant.
- Sensitivity Issues: Participants with altered sensitivity in the lower limbs or any condition that may affect the response to the techniques.
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 |
|---|---|---|
| Foam rollerThe foam roller is used for self-myofascial release (SMR) to reduce muscle tightness and improve flexibility. In this study, participants will use the foam roller on their dominant calf muscles, rolling it up and down at a controlled pace (30 rolls per minute). The pressure applied should be moderate, staying within a pain tolerance of 6/10 on the Visual Analogue Scale (VAS). The technique is repeated three times, with a one-minute rest between sets. The goal is to enhance muscle relaxation and reduce muscle tone | Other | Foam roller |
| MassageThe therapeutic massage used in this study involves manual techniques to reduce muscle tone and improve flexibility in the calf muscles. It includes: 1. Deep Gliding Stroke: Sliding from the upper to the lower part of the calf to relax the muscles. 2. Soleus Compression: Applying pressure to the soleus muscle with the hands to release tension. 3. Calf Compression: Applying pressure to specific points on the calf to alleviate stiffness. Each technique lasts for 2 minutes, with a total intervention time of 8 minutes per participant. The goal is to reduce muscle tone and enhance relaxation | Other | Massage |
Primary outcome
Muscle tone
Time frame: Pre and post intervention (immediately post foam roller procedure)
Description: Muscle tone refers to the continuous and passive tension in a muscle at rest, measured by its resistance to passive stretching. It is quantified in Hertz (Hz), indicating the frequency of oscillation when the muscle is in a relaxed state.
2 secondary outcomes
Muscle stiffness
Time frame: Pre intervention and post intervention (immediately after the foam roller procedure)
Muscle elasticity
Time frame: pre and post intervention (immediately after the interventions)
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 16 Oct 2026.
- Background: PubMed 33917668Perez-Bellmunt A, Labata-Lezaun N, Llurda-Almuzara L, Rodriguez-Sanz J, Gonzalez-Rueda V, Bueno-Gracia E, Celik D, Lopez-de-Celis C. Effects of a Massage Protocol in Tensiomyographic and Myotonometric Proprieties. Int J Environ Res Public Health. 2021 Apr 8;18(8):3891. doi: 10.3390/ijerph18083891.
- Background: PubMed 31681002Laffaye G, Da Silva DT, Delafontaine A. Self-Myofascial Release Effect With Foam Rolling on Recovery After High-Intensity Interval Training. Front Physiol. 2019 Oct 16;10:1287. doi: 10.3389/fphys.2019.01287. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam roller and Massage in people with Muscle Tone and Healthy Adult, run by Universidad Europea de Madrid at 1 site in Spain.
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 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 16 Oct 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 Spain. 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?
Muscle tone (time frame: Pre and post intervention (immediately post foam roller procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07564206, which also lists 2 linked publications.
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 16 Oct 2026.