NCT07564206

Brief 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). 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 26, 2026

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre and post intervention (immediately post foam roller procedure)

Secondary Outcomes (2)

  • Muscle stiffness

    Pre intervention and post intervention (immediately after the foam roller procedure)

  • Muscle elasticity

    pre and post intervention (immediately after the interventions)

Study Arms (2)

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).

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

Other: Massage

Interventions

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

Foam roller
MassageOTHER

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

Massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33917668BACKGROUND
  • 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.

    PMID: 31681002BACKGROUND

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 4, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04