Health BehaviorAUTOMASSEEGNCT04859140
Selective Effect of Foam Rolling and Manual Massage
A study testing Psychometric ratings (Likert-scale), Range of motion measures and Mental calculation task in people with Health Behavior and Health, Subjective, run by Laboratoire Interuniversitaire de Biologie de la Motricité at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health, Subjective, Health Knowledge, Attitudes, Practice
- What is being tested?
- Psychometric ratings (Likert-scale), Range of motion measures and Mental calculation task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 1 Apr 2021
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular practice of foam rolling (10 min routines, 2-3 times per week over the past 6 months)
Who cannot join
- Chronic medical conditions including functional limitations that might affect proprioception and/or pain perception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychometric ratings (Likert-scale), Range of motion measures, Mental calculation task, Resting-state electroencephalography, Resting-state galvanic skin resistance measures
- Keywords
- electroencephalography, electrodermal activity, flexibility, alertness
- Medical subject headings
- Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric ratings (Likert-scale)Other
Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth)
Range of motion measuresBehavioural
Sit-and-reach and toe touch tests
Mental calculation taskBehavioural
Iterated substractions (for 2 minutes)
Resting-state electroencephalographyDevice
Alpha and beta oscillation power (4 minutes recordings)
Resting-state galvanic skin resistance measuresDevice
Skin conductance during the resting state period
| Study group | Role | What they receive |
|---|---|---|
| Foam rolling | Experimental | 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. Receives: Other: Psychometric ratings (Likert-scale); Behavioral: Range of motion measures; Behavioral: Mental calculation task; Device: Resting-state electroencephalography; Device: Resting-state galvanic skin resistance measures |
| Manual massage | Experimental | 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. Receives: Other: Psychometric ratings (Likert-scale); Behavioral: Range of motion measures; Behavioral: Mental calculation task; Device: Resting-state electroencephalography; Device: Resting-state galvanic skin resistance measures |
| Autogenic relaxation | Active comparator | 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. Receives: Other: Psychometric ratings (Likert-scale); Behavioral: Range of motion measures; Behavioral: Mental calculation task; Device: Resting-state electroencephalography; Device: Resting-state galvanic skin resistance measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion measures from standardized flexibility tests
Lower back and hamstring flexibility index from sit-and-reach and toe touch tests
Measured: Pretest and an immediate posttest after the intervention
Resting-state electroencephalography
Power of alpha and beta neural oscillations
Measured: Pretest and an immediate posttest after the intervention
Changes in subjective scores (self-reports on numeric rating scales)
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")
Measured: Pretest and an immediate posttest after the intervention
Changes in mental calculation performances
Iterated substractions for 2 minutes
Measured: Pretest and an immediate posttest after the intervention
Changes in physiological arousal
Skin conductance during resting state periods
Measured: Pretest and an immediate posttest after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three independent groups, two measurement points
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Interuniversitaire de Biologie de la Motricité
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Aymeric Guillot, Laboratoire Interuniversitaire de Biologie de la Motricité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859140
- Sponsor's protocol ID
- LIBMNEURO - AUTOMASSEEG
- Acronym
- AUTOMASSEEG
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-myofascial Release and Manual Massage on Psychometric, Behavioural and Neurophysiological Indexes of Performance and Well-being: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04859140
- Acronym / sponsor ID
- AUTOMASSEEG / LIBMNEURO - AUTOMASSEEG
- Keywords
- electroencephalography, electrodermal activity, flexibility, alertness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Laboratoire Interuniversitaire de Biologie de la MotricitéUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 26 Apr 2021 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Three independent groups, two measurement points
| Arm | Type | Receives |
|---|---|---|
| Foam rolling | Experimental | Other: Psychometric ratings (Likert-scale), Behavioral: Range of motion measures, Behavioral: Mental calculation task, Device: Resting-state electroencephalography, Device: Resting-state galvanic skin resistance measuresThe 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. |
| Manual massage | Experimental | Other: Psychometric ratings (Likert-scale), Behavioral: Range of motion measures, Behavioral: Mental calculation task, Device: Resting-state electroencephalography, Device: Resting-state galvanic skin resistance measuresParticipants 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. |
| Autogenic relaxation | Active comparator | Other: Psychometric ratings (Likert-scale), Behavioral: Range of motion measures, Behavioral: Mental calculation task, Device: Resting-state electroencephalography, Device: Resting-state galvanic skin resistance measuresParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Regular practice of foam rolling (10 min routines, 2-3 times per week over the past 6 months)
Key exclusion criteria (1 listed)
- Chronic medical conditions including functional limitations that might affect proprioception and/or pain perception
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 |
|---|---|---|
| Psychometric ratings (Likert-scale)Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth) | Other | Autogenic relaxation, Foam rolling, Manual massage |
| Range of motion measuresSit-and-reach and toe touch tests | Behavioural | Autogenic relaxation, Foam rolling, Manual massage |
| Mental calculation taskIterated substractions (for 2 minutes) | Behavioural | Autogenic relaxation, Foam rolling, Manual massage |
| Resting-state electroencephalographyAlpha and beta oscillation power (4 minutes recordings) | Device | Autogenic relaxation, Foam rolling, Manual massage |
| Resting-state galvanic skin resistance measuresSkin conductance during the resting state period | Device | Autogenic relaxation, Foam rolling, Manual massage |
Primary outcome
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
Resting-state electroencephalography
Time frame: Pretest and an immediate posttest after the intervention
Power of alpha and beta neural oscillations
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")
Changes in mental calculation performances
Time frame: Pretest and an immediate posttest after the intervention
Iterated substractions for 2 minutes
Changes in physiological arousal
Time frame: Pretest and an immediate posttest after the intervention
Skin conductance during resting state periods
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 26 Apr 2021.
- 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 Psychometric ratings (Likert-scale), Range of motion measures and Mental calculation task in people with Health Behavior and Health, Subjective, run by Laboratoire Interuniversitaire de Biologie de la Motricité at 1 site in France.
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 1 inclusion and 1 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 26 Apr 2021. 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 France. 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 range of motion measures from standardized flexibility tests (time frame: Pretest and an immediate posttest after the intervention). The study lists 5 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 26 Apr 2021.