- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07564206
Foam Roller Compared to Massage on Reducing Calf Muscle Tone in Healthy Subjects (FRTONE)
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]).
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carlos Romero Phd
- Phone Number: +34686849824
- Email: CARLOS.ROMERO@UNIVERSIDADEUROPEA.ES
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Foam roller
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). |
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 |
|
Active Comparator: Massage
The therapeutic massage used in this study involves manual techniques to reduce muscle tone and improve flexibility in the calf muscles. It includes:
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 |
The therapeutic massage used in this study involves manual techniques to reduce muscle tone and improve flexibility in the calf muscles. It includes:
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre and post intervention (immediately post foam roller procedure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle stiffness
Time Frame: Pre intervention and post intervention (immediately after the foam roller procedure)
|
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.
|
Pre intervention and post intervention (immediately after the foam roller procedure)
|
|
Muscle elasticity
Time Frame: pre and post intervention (immediately after the interventions)
|
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.
|
pre and post intervention (immediately after the interventions)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Laffaye 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI-2026-338
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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