Neuromuscular DiseasesNCT03941067
Effects of Pre-event Massage Over the Neuromuscular Response
A study testing Pre-event massage in people with Neuromuscular Diseases, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The study observes the effect of a pre-event massage on the gastrocnemius muscles over the neuromuscular response of the gastrocnemious muscles. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Pre-event massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2019to 7 Jun 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Muscle injury in the last two months
- To not understand the study orders
- Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Effects of Pre-event Massage Over the Neuromuscular Response of Gastrocnemius Muscles
The study observes the effect of a pre-event massage on the gastrocnemius muscles over the neuromuscular response of the gastrocnemious muscles.
- Conditions
- Neuromuscular Diseases
- Being tested
- Pre-event massage
- Keywords
- Neuromuscular response, pre-competition massage, pre-event massage
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-event massageOther
Five minutes massage, combining superficial and high-frequency techniques of massage applied with the therapist hands
| Study group | Role | What they receive |
|---|---|---|
| Pre-event massage | Experimental | Not described Receives: Other: Pre-event massage |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay time change
Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Measured: 2 minutes before the intervention, and 8 minutes after the intervention
Contraction time change
Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Measured: 2 minutes before the intervention, and 8 minutes after the intervention
Sustain time change
time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Measured: 2 minutes before the intervention, and 8 minutes after the intervention
Relaxation time change
time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Measured: 2 minutes before the intervention, and 8 minutes after the intervention
Maximal displacement change
Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).
Measured: 2 minutes before the intervention, and 8 minutes after the intervention
Secondary outcomes (6)
Gastrocnemious strength change
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
Measured: 8 minutes before the intervention, and 2 minutes after the intervention
Passive ankle dorsiflexion change
Passive range of motion of the ankle dorsiflexion, using an inclinometer (degrees).
Measured: 6 minutes before the intervention, and 4 minutes after the intervention
Jump height change
Maximum jump height with one leg using the application "My Jump 2" (centimeters).
Measured: 10 minutes before the intervention, and 1 minute after the intervention
Stiffness change
Resistance to an external force that deforms its initial shape, using a "Myoton".
Measured: 5 minute before the intervention, and 5 minute after the intervention
Elasticity change
Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton".
Measured: 5 minute before the intervention, and 5 minute after the intervention
Relaxation change
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).
Measured: 5 minute before the intervention, and 5 minute 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 posted7 May 2019
- Study start2 May 2019
- Primary completion7 Jun 2019 (estimated)
- Study completion7 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Pérez Bellmunt, Universitat Internacional de Catalunya
- Investigators
- Albert Pérez-Bellmunt, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941067
- Sponsor's protocol ID
- Protocol 4
- Status last verified
- Feb 2019
- First submitted
- 3 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33917668
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-event Massage Over the Neuromuscular Response of Gastrocnemius Muscles
- ClinicalTrials.gov ID
- NCT03941067
- Acronym / sponsor ID
- Protocol 4
- Conditions
- Neuromuscular Diseases
- Keywords
- Neuromuscular response, pre-competition massage, pre-event massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 7 Jun 2019 (estimated)
- Study completion
- 7 Jun 2019 (estimated)
- First posted
- 7 May 2019 (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 study observes the effect of a pre-event massage on the gastrocnemius muscles over the neuromuscular response of the gastrocnemious muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-event massage | Experimental | Other: Pre-event massage |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Muscle injury in the last two months
- To not understand the study orders
- Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
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 |
|---|---|---|
| Pre-event massageFive minutes massage, combining superficial and high-frequency techniques of massage applied with the therapist hands | Other | Pre-event massage |
Primary outcome
Delay time change
Time frame: 2 minutes before the intervention, and 8 minutes after the intervention
Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Contraction time change
Time frame: 2 minutes before the intervention, and 8 minutes after the intervention
Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Sustain time change
Time frame: 2 minutes before the intervention, and 8 minutes after the intervention
time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Relaxation time change
Time frame: 2 minutes before the intervention, and 8 minutes after the intervention
time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Maximal displacement change
Time frame: 2 minutes before the intervention, and 8 minutes after the intervention
Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).
6 secondary outcomes
Gastrocnemious strength change
Time frame: 8 minutes before the intervention, and 2 minutes after the intervention
Passive ankle dorsiflexion change
Time frame: 6 minutes before the intervention, and 4 minutes after the intervention
Jump height change
Time frame: 10 minutes before the intervention, and 1 minute after the intervention
Stiffness change
Time frame: 5 minute before the intervention, and 5 minute after the intervention
Elasticity change
Time frame: 5 minute before the intervention, and 5 minute after the intervention
Relaxation change
Time frame: 5 minute before the intervention, and 5 minute after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Derived from this study: 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.
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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.
Albert Pérez-Bellmunt principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-event massage in people with Neuromuscular Diseases, run by Universitat Internacional de Catalunya 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 0 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 May 2019. 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?
Results are not available in the source record.
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?
Delay time change (time frame: 2 minutes before the intervention, and 8 minutes 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?
On the ClinicalTrials.gov record for NCT03941067, which also lists 1 linked publication.
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 7 May 2019.