Selective Effect of Foam Rolling and Manual Massage (AUTOMASSEEG)

April 21, 2021 updated by: Prof. Aymeric Guillot, Laboratoire Interuniversitaire de Biologie de la Motricité

Effects of Self-myofascial Release and Manual Massage on Psychometric, Behavioural and Neurophysiological Indexes of Performance and Well-being: a Randomized Control Trial

The present double-blinded randomized controlled design aims at comparing the effects of a full-body manual massage and foam rolling intervention. Sixty-five healthy individuals were randomly allocated to foam rolling, manual massage or a control intervention consisting in an autogenic relaxation routine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Self-report ratings of perceived anxiety, muscle pain and relaxation were the psychometric outcome variables. Sit-and-reach, toes-touch and mental calculation performances were the behavioral variables. Resting-state alpha and beta power recorded using electroencephalography and galvanic skin resistance measures were the neurophysiological outcome variables.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villeurbanne, France, 69622
        • University Claude Bernard Lyon 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Regular practice of foam rolling (10 min routines, 2-3 times per week over the past 6 months)

Exclusion Criteria:

  • Chronic medical conditions including functional limitations that might affect proprioception and/or pain perception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Foam rolling
The foam rolling routine consisted in unilateral exercises alternatively performed on both legs and bilateral exercises on lower and back muscles. All participants started with the feet in a standing up position with a lacrosse ball. Then, participants performed on the ground the foam rolling exercises with the foam roller targeting leg and back muscles.
Other: Psychometric ratings (Likert-scale)
Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth)
Behavioral: Range of motion measures
Sit-and-reach and toe touch tests
Behavioral: Mental calculation task
Iterated substractions (for 2 minutes)
Device: Resting-state electroencephalography
Alpha and beta oscillation power (4 minutes recordings)
Device: Resting-state galvanic skin resistance measures
Skin conductance during the resting state period
Experimental: Manual massage
Participants in the manual massage group received manual massage by a professional physiotherapist who was blinded to the purpose of the experiment (20 years of registered practice). Participants were lying in the prone position on a massage table. To facilitate the physiotherapist's maneuvers, massage oil was used. The manual massage protocol reproduced several features of the foam rolling intervention, i.e., order of the areas massaged, massage time per muscles and total duration of the session.
Other: Psychometric ratings (Likert-scale)
Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth)
Behavioral: Range of motion measures
Sit-and-reach and toe touch tests
Behavioral: Mental calculation task
Iterated substractions (for 2 minutes)
Device: Resting-state electroencephalography
Alpha and beta oscillation power (4 minutes recordings)
Device: Resting-state galvanic skin resistance measures
Skin conductance during the resting state period
Active Comparator: Autogenic relaxation
Participants in the relaxation group listened to a 16 min relaxation audio tape, based on the autogenic training method. Participants were lying on the massage table in supine position, wearing headphones. During this desensitization-relaxation technique, they were guided to visualize bodily perceptions of heaviness and warmth in their arms, thorax and legs. To facilitate concentration, participants were left alone in a dark room.
Other: Psychometric ratings (Likert-scale)
Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth)
Behavioral: Range of motion measures
Sit-and-reach and toe touch tests
Behavioral: Mental calculation task
Iterated substractions (for 2 minutes)
Device: Resting-state electroencephalography
Alpha and beta oscillation power (4 minutes recordings)
Device: Resting-state galvanic skin resistance measures
Skin conductance during the resting state period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in range of motion measures from standardized flexibility tests
Time Frame: Pretest and an immediate posttest after the intervention
Lower back and hamstring flexibility index from sit-and-reach and toe touch tests
Pretest and an immediate posttest after the intervention
Resting-state electroencephalography
Time Frame: Pretest and an immediate posttest after the intervention
Power of alpha and beta neural oscillations
Pretest and an immediate posttest after the intervention
Changes in subjective scores (self-reports on numeric rating scales)
Time Frame: Pretest and an immediate posttest after the intervention
Perceived anxiety and physical sensations (muscle pain, warmth and relaxation) on a numeric rating scale of 10 cm (0: "Complete absence of anxiety/muscle pain/muscle warmth/muscle relaxation"; 10: "Maximal possible levels of anxiety/muscle pain/muscle warmth/muscle relaxation")
Pretest and an immediate posttest after the intervention
Changes in mental calculation performances
Time Frame: Pretest and an immediate posttest after the intervention
Iterated substractions for 2 minutes
Pretest and an immediate posttest after the intervention
Changes in physiological arousal
Time Frame: Pretest and an immediate posttest after the intervention
Skin conductance during resting state periods
Pretest and an immediate posttest after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratoire Interuniversitaire de Biologie de la Motricité

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIBMNEURO - AUTOMASSEEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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