Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000841774
Ethics application status
Approved
Date submitted
12/05/2022
Date registered
15/06/2022
Date last updated
15/06/2022
Date data sharing statement initially provided
15/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of the treatment with peripheral electromagnetic stimulation in healthy male soccer players after inducing delayed onset muscle soreness (DOMS) with one hour of resistance exercises with an eccentric component: A randomized controlled trial
Scientific title
Effects of the treatment with peripheral electromagnetic stimulation in healthy male soccer players after inducing delayed onset muscle soreness (DOMS) with one hour of resistance exercises with an eccentric component: A randomized controlled trial
Secondary ID [1] 307107 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed onset muscle soreness 326269 0
Condition category
Condition code
Musculoskeletal 323572 323572 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 323573 323573 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The players will perform a conventional warm up, similar to a normal practice, afterwards they will follow Howatson et al. protocol (1 hour duration) to induce DOMS which will consist in 10 series of 10 repetitions of jumps from a box 40 cm height. Afterwards they will perform 3 series of 10 repetitions of a Bulgarian squat, front squat and one leg squat. While the players perform the exercises the physical therapist in charge of the protocol and of the supervision of the players will be asking how they feel, to adapt the loads to achieve at least a 7 out of 10 in the modified Borg scale or the 70% of their 1RM

Once they have finished the exercise protocol, the players that are in the intervention group will receive their first session of electromagnetic stimulation of a total of 3. Each session, first one after the exercise protocol and the next two will be administrated at the same hour in 3 consecutive days with the same stimulation protocol. This stimulation protocol consist in a total of 5 trains of pulses at 100hz of frequency of a duration of 5 seconds with 55 seconds rest. The intensity will be a sensitive threshold, the player should feel the current induced by the magnetic field but the physical therapist expert in electrotherapy can not see a muscle contraction
The placebo group will receive the same treating protocol the same days and hours of the day with the difference that in this players the electromagnetic coil will be placed 10 cm above the stimulation point.

The stimulation point will be the femoral nerve located in the proximal and medial side of the thigh, while the players lays on a supine position
Intervention code [1] 323561 0
Rehabilitation
Intervention code [2] 323562 0
Treatment: Devices
Comparator / control treatment
the control group will receive a placebo treatment Wich it will consist in the same application with the same device and the same intensity but placing the coil 10 cm higher to the stimulation point, This distance does not allowed the electromagnetic field to stimulate the nerve.
Control group
Placebo

Outcomes
Primary outcome [1] 331328 0
Superficial electromyography for vastus medialis with the Mdurance device will be used to asses muscle activation.
Timepoint [1] 331328 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours(primary endpoint) after the intervention
Primary outcome [2] 331329 0
isometric strength measured with a dynamometer for leg extension
Timepoint [2] 331329 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours(primary endpoint) after the intervention
Primary outcome [3] 331330 0
Pain to pressure measured with an algometer in Zone 1 of the quadriceps, from 0 to 3 cm with respect to the upper pole of the patella.
Timepoint [3] 331330 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours(primary endpoint) after the intervention
Secondary outcome [1] 409538 0
pain will be also measured with the visual analogue scale with a maximum score of 100.
Timepoint [1] 409538 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
Secondary outcome [2] 410003 0
Superficial electromyography for rectus femoris with the Mdurance device will be used to asses muscle activation.(This is a primary outcome)
Timepoint [2] 410003 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
Secondary outcome [3] 410004 0
Superficial electromyography for vastus medalis with the Mdurance device will be used to asses muscle activation.(This is a primary outcome)
Timepoint [3] 410004 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
Secondary outcome [4] 410005 0
Pain to pressure measured with an algometer in Zone 2 of the quadriceps, from 3 to 6 cm with respect to the upper pole of the patella. ( this is a primary outcome)
Timepoint [4] 410005 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
Secondary outcome [5] 410006 0
Pain to pressure measured with an algometer in Zone 3 of the quadriceps, from 6 to 9 cm with respect to the upper pole of the patella. ( this is a primary outcome)
Timepoint [5] 410006 0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention

Eligibility
Key inclusion criteria
healthy soccer profesional male players will be recruited
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Players injured, or that could not perform the tests in their best conditions will be excluded

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the allocation will be done using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be done using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
the sample size has been calculated using the gram program based on a previous study using similar therapies. accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral constant, 24 subjects are required to detect a difference equal to or greater than 3 units. a standard deviation of 4.9 is assumed and a sample loss of 10% is estimated

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
15/07/2022
Actual
Date of last data collection
Anticipated
18/07/2022
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 24760 0
Spain
State/province [1] 24760 0
Madrid

Funding & Sponsors
Funding source category [1] 311414 0
Self funded/Unfunded
Name [1] 311414 0
Country [1] 311414 0
Primary sponsor type
University
Name
Universidad Europea de Madrid
Address
C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
Country
Spain
Secondary sponsor category [1] 312811 0
None
Name [1] 312811 0
Address [1] 312811 0
Country [1] 312811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310893 0
comité de ética e investigación de la universidad europea de madrid
Ethics committee address [1] 310893 0
Ethics committee country [1] 310893 0
Spain
Date submitted for ethics approval [1] 310893 0
Approval date [1] 310893 0
03/03/2022
Ethics approval number [1] 310893 0
CIPI/22.095

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119258 0
Mr Hugo Kériven
Address 119258 0
C. Tajo, s/n, 28670 Villaviciosa de Odón, 28005, Madrid. Spain. Departament of physical therapy. Universidad Europea de Madrid.
Country 119258 0
Spain
Phone 119258 0
+34 691640091
Fax 119258 0
Email 119258 0
[email protected]
Contact person for public queries
Name 119259 0
Alberto Sánchez Sierra
Address 119259 0
C. Tajo, s/n, 28670 Villaviciosa de Odón, 28005, Madrid. Spain. Departament of physical therapy. Universidad Europea de Madrid
Country 119259 0
Spain
Phone 119259 0
+34 608801238
Fax 119259 0
Email 119259 0
[email protected]
Contact person for scientific queries
Name 119260 0
Alberto Sánchez Sierra
Address 119260 0
C. Tajo, s/n, 28670 Villaviciosa de Odón, 28005, Madrid. Spain. Departament of physical therapy. Universidad Europea de Madrid
Country 119260 0
Spain
Phone 119260 0
+34 608801238
Fax 119260 0
Email 119260 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• it will be available to the scientific community once we have check the purposes


Conditions for requesting access:
• -

What individual participant data might be shared?
• all the data collected during the investigation will be shared

What types of analyses could be done with individual participant data?
• it will be available for any purpose related to our investigation

When can requests for individual participant data be made (start and end dates)?
From:
the data will be available once we have publish it. there will be no end date for this propose

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• the data will be shared contacting via email contacting to [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16018Ethical approval    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of peripheral electromagnetic stimulation after an eccentric exercise-induced delayed-onset muscle soreness protocol in professional soccer players: a randomized controlled trial.2023https://dx.doi.org/10.3389/fphys.2023.1206293
N.B. These documents automatically identified may not have been verified by the study sponsor.