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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
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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
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Secondary ID [1]
307107
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Delayed onset muscle soreness
326269
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Condition category
Condition code
Musculoskeletal
323572
323572
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
323573
323573
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
323561
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Rehabilitation
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Intervention code [2]
323562
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Treatment: Devices
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
331328
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Superficial electromyography for vastus medialis with the Mdurance device will be used to asses muscle activation.
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Assessment method [1]
331328
0
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Timepoint [1]
331328
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It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours(primary endpoint) after the intervention
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Primary outcome [2]
331329
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isometric strength measured with a dynamometer for leg extension
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Assessment method [2]
331329
0
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Timepoint [2]
331329
0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours(primary endpoint) after the intervention
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Primary outcome [3]
331330
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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.
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Assessment method [3]
331330
0
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Timepoint [3]
331330
0
It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours(primary endpoint) after the intervention
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Secondary outcome [1]
409538
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pain will be also measured with the visual analogue scale with a maximum score of 100.
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Assessment method [1]
409538
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Timepoint [1]
409538
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It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
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Secondary outcome [2]
410003
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Superficial electromyography for rectus femoris with the Mdurance device will be used to asses muscle activation.(This is a primary outcome)
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Assessment method [2]
410003
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Timepoint [2]
410003
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It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
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Secondary outcome [3]
410004
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Superficial electromyography for vastus medalis with the Mdurance device will be used to asses muscle activation.(This is a primary outcome)
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Assessment method [3]
410004
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Timepoint [3]
410004
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It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
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Secondary outcome [4]
410005
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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)
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Assessment method [4]
410005
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Timepoint [4]
410005
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It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
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Secondary outcome [5]
410006
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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)
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Assessment method [5]
410006
0
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Timepoint [5]
410006
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It will be measured pre intervention, immediately post intervention, 24, 48 and 72 hours after the intervention
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Eligibility
Key inclusion criteria
healthy soccer profesional male players will be recruited
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Players injured, or that could not perform the tests in their best conditions will be excluded
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the allocation will be done using sealed opaque envelopes.
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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
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2022
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Actual
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Date of last participant enrolment
Anticipated
15/07/2022
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Actual
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Date of last data collection
Anticipated
18/07/2022
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
24760
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Spain
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State/province [1]
24760
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Madrid
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Funding & Sponsors
Funding source category [1]
311414
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Self funded/Unfunded
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Name [1]
311414
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Address [1]
311414
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Country [1]
311414
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Primary sponsor type
University
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Name
Universidad Europea de Madrid
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Address
C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
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Country
Spain
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Secondary sponsor category [1]
312811
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None
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Name [1]
312811
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Address [1]
312811
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Country [1]
312811
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310893
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comité de ética e investigación de la universidad europea de madrid
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Ethics committee address [1]
310893
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C. Tajo, s/n, 28670 Villaviciosa de Odón, Madrid
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Ethics committee country [1]
310893
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Spain
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Date submitted for ethics approval [1]
310893
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Approval date [1]
310893
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03/03/2022
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Ethics approval number [1]
310893
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CIPI/22.095
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Summary
Brief summary
The main purpose of this investigation is to seek a method that can reduce the time of muscle recovery after a high intensity effort. The new theories about the delay onset muscle soreness talk about an axonal compression and an alteration of the neural system. Modulating the neuromuscular system using an electromagnetic field that due to Faraday´s law can also generate a low frequency current, could reduce the time of recovery which is estimated in 72 hours. hypothesis: The application of an electromagnetic stimulation in professional soccer players after inducing DOMS with 1 hour of eccentric exercises, improves recovery and increases performance.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
119258
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Mr Hugo Kériven
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Address
119258
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C. Tajo, s/n, 28670 Villaviciosa de Odón, 28005, Madrid. Spain. Departament of physical therapy. Universidad Europea de Madrid.
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Country
119258
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Spain
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Phone
119258
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+34 691640091
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Fax
119258
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Email
119258
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[email protected]
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Contact person for public queries
Name
119259
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Alberto Sánchez Sierra
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Address
119259
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C. Tajo, s/n, 28670 Villaviciosa de Odón, 28005, Madrid. Spain. Departament of physical therapy. Universidad Europea de Madrid
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Country
119259
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Spain
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Phone
119259
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+34 608801238
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Fax
119259
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Email
119259
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[email protected]
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Contact person for scientific queries
Name
119260
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Alberto Sánchez Sierra
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Address
119260
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C. Tajo, s/n, 28670 Villaviciosa de Odón, 28005, Madrid. Spain.
Departament of physical therapy.
Universidad Europea de Madrid
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Country
119260
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Spain
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Phone
119260
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+34 608801238
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Fax
119260
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Email
119260
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all the data collected during the investigation will be shared
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When will data be available (start and end dates)?
the data will be available once we have publish it. there will be no end date for this propose
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Available to whom?
it will be available to the scientific community once we have check the purposes
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Available for what types of analyses?
it will be available for any purpose related to our investigation
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How or where can data be obtained?
the data will be shared contacting via email contacting to
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16018
Ethical approval
384050-(Uploaded-12-05-2022-08-05-11)-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
Source
Title
Year of Publication
DOI
Embase
Effects of peripheral electromagnetic stimulation after an eccentric exercise-induced delayed-onset muscle soreness protocol in professional soccer players: a randomized controlled trial.
2023
https://dx.doi.org/10.3389/fphys.2023.1206293
N.B. These documents automatically identified may not have been verified by the study sponsor.
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