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Trial registered on ANZCTR
Registration number
ACTRN12619000678190
Ethics application status
Approved
Date submitted
18/04/2019
Date registered
6/05/2019
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
6/05/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Photobiomodulation therapy for muscle damage and fatigue following electrical stimulation - a controlled trial
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Scientific title
The effect of low level laser irradiation on oxidative stress, muscle damage and fatigue following neuromuscular electrical stimulation - a double blind, cross-over trial
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Secondary ID [1]
298004
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Nil known
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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 (DOMS)
312454
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exercise induced muscle damage (EIMD)
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Condition category
Condition code
Physical Medicine / Rehabilitation
311003
311003
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0
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Physiotherapy
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Musculoskeletal
311004
311004
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A single session of low level laser therapy (LLLT) irradiations, of an approximate duration of 18 minutes, provided by a physiotherapist, in six skin areas (25 cm2 each, with direct contact of the probe to skin, with slight pressure), i.e. 5 cm above the middle of the line connecting the anterior superior iliac spine and the base of patella and 5 cm below that spot, in two areas above the vastus medialis muscle belly, and in two areas above the vastus lateralis muscle belly. The dose of 30 J (preventing from the thermal effects to occur) applied in each area (i. e the overall dose of 180 J), with a cluster probe consisting of four semiconducting lasers, 830 nm, of 200 mW each, using BTL 5000 device (BTL Industries Limited, London).
The LLLT, or sham LLLT, session was followed by a NMES session, provided by a physiotherapist. It consisted of forty five electrically evoked tetanic, isometric contractions, in the 5 sec. ON, 15 sec. OFF mode, with 1.5 sec. ramp-on and 0.5 sec. ramp-off times (15 minutes overall time of the NMES session). NMES was performed with the use of a stationary electrical stimulator Sonicator Plus 940 (Mettler Electronics Corporation, USA), generating pulsed, two-phase, 300 µs, square-wave, symmetrical, delivered at 80 Hz, current. Four (two electric circuits) round, self-adhesive, 5 cm diameter electrodes were placed over motor points, on previously rinsed with alcohol and dried skin The current intensity was set at the level of tolerance (below pain threshold) and adjusted by the physiotherapist to that level when needed during the session. There are no strategies used to assess or monitor fidelity to this study. At the first stage of this crossover study, group 1 (n=12) received NMES and LLLT, while group 2 (n=12) received NMES and sham LLLT. A reverse procedure was applied after an eight-day wash-out period, sufficient to eliminate the carryover effect.
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Intervention code [1]
314235
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Treatment: Other
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Comparator / control treatment
Sham therapy. (identical to LLLT intervention except the light outputs of the probe covered with aluminium foil).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Muscle soreness assessed using a 100mm Visual Analogue Scale (VAS), following a maneuvre of pressing a participant’s leg for 3 seconds with his fingers (1) 5 cm proximally, (2) 5 cm distally to the central area between the base of patella and anterior superior iliac spine, and over motor points of (3) vastus medialis and (4) vastus lateralis muscles; two assessments conducted: prior to and following a squat exercise. This is a composite primary outcome.
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Assessment method [1]
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Timepoint [1]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.. The primary timepoint is 96 hours post NMES.
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Primary outcome [2]
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Maximal voluntary contraction in statics, (MVC) of knee extensor muscles, measured with the use of the Biodex System 4 Pro measuring device (Biodex Medical System, USA), in participants in a sitting position, with their knees bent at an angle of 100° measured from the 0° extension of the knee joint, pelvis, thighs and trunk stabilised with straps, stabilisation handles gripped; non-dominant legs examined. This is a composite primary outcome.
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Assessment method [2]
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Timepoint [2]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.. The primary timepoint is 96 hours post NMES.
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Secondary outcome [1]
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Redox parameter 1: the activity of superoxide dismutase (SOD) in erythrocytes, determined with commercially available kits (RANSOD Cat. No. SD 125; Randox, Crumlin, UK).
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Assessment method [1]
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Timepoint [1]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
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Secondary outcome [2]
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Redox parameter 2: the activity of glutathione peroxidase (GPx) in whole blood, determined with commercially available kits (RANSEL Cat. No. RS 505, Randox, Crumlin, UK).
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Assessment method [2]
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Timepoint [2]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
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Secondary outcome [3]
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Redox parameter 3: the total antioxidant capacity (TAC) of plasma measured at 37 °C and expressed in U/g Hb; Haemoglobin (Hb) assessed by a standard cyanmethaemoglobin method, using a diagnostic kit (HG 1539; Randox, Crumlin, UK).
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Assessment method [3]
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Timepoint [3]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
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Secondary outcome [4]
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Redox parameter 4: the level of malondialdehyde (MDA) in plasma, measured using a chromogenic method, with commercially available kit (Cat. No. NX 2332, Randox, Crumlin, UK).
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Assessment method [4]
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Timepoint [4]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
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Secondary outcome [5]
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Concentration of uric acid (UA) in plasma, determined with the use of a diagnostic kit Cat. No. C6512-100, Alpha Diagnostics, Poland.
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Assessment method [5]
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Timepoint [5]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
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Secondary outcome [6]
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Concentration of C-reactive protein (CRP) in plasma; determined with the use of a diagnostic kit Cat. No. K6580-200, Alpha Diagnostics, Poland.
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Assessment method [6]
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Timepoint [6]
369848
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
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Secondary outcome [7]
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Creatine kinase (CK) activity in plasma, determined with the use of a diagnostic kit Cat. No. C6428-075, Alpha Diagnostics, Poland.
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Assessment method [7]
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Timepoint [7]
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Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
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Eligibility
Key inclusion criteria
Healthy, moderatey physically active participants.
The moderate physical activity level as defined in the International Physical Activity Questionnaire (IPAQ): “doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days”.
Healthy, i.e. free from medical conditions, such as lower limb injuries within a year prior to the study, current inflammation and contraindications to NMES or LLLT.
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Minimum age
20
Years
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Maximum age
24
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
routine, intensive, competitive physical activity;
sedentary lifestyle;
lower limb injuries within a year prior to the study;
current inflammation;
contraindications to NMES or LLLT.
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Study design
Purpose of the study
Treatment
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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)
Allocation not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants assigned to the groups through simple randomisation (tossing a coin),
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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
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Intervention assignment
Crossover
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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
Characteristics of participants analysed with descriptive statistics (mean, SD and range). The corrected pairwise t-test for multiple hypotheses used to analyse muscle strength variability; the Kruskal-Wallis test employed to evaluate muscle soreness.; the findings regarding muscle soreness shown on a T scale.; the sham-LLLT normalised into the actual intervention (LLLT); biochemical parameters and MVC torques analysed using two-way ANOVA: 2 (interventions: LLLT and sham-LLLT) multiplied by 6 (time points: baseline, 0, 24, 48, 72, 96 hours), with the Bonferroni post-hoc test for multiple comparisons, and the values presented as means with standard error (SE). The Statistica v. 12.0 software package used for calculations.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
15/05/2015
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Date of last participant enrolment
Anticipated
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Actual
25/05/2015
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Date of last data collection
Anticipated
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Actual
20/08/2016
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Sample size
Target
24
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Accrual to date
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Final
24
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Recruitment outside Australia
Country [1]
21422
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Poland
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State/province [1]
21422
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lubelskie voivodship
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Funding & Sponsors
Funding source category [1]
302528
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University
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Name [1]
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Józef Pilsudski University of Physical Education, Warsaw
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Address [1]
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Marymoncka 34, 00-968 Warszawa
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Country [1]
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Poland
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Primary sponsor type
University
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Name
Józef Pilsudski University of Physical Education, Warsaw
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Address
Marymoncka 34, 00-968 Warszawa
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Country
Poland
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
302440
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Nil
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Country [1]
302440
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303179
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The Research Ethics Committee, University of Physical Education, Warsaw, Poland
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Ethics committee address [1]
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Marymoncka 34, 00-968 Warszawa, Poland
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Ethics committee country [1]
303179
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Poland
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Date submitted for ethics approval [1]
303179
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Approval date [1]
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26/06/2014
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Ethics approval number [1]
303179
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SKE 01-14/2014
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Summary
Brief summary
Neuromuscular electrical stimulation (NMES) is considered a standard, physiotherapeutic and training intervention, utilised for restoring, preserving or improving muscle strength and functional capacities, from different health conditions to athlete training. Nonetheless, NMES may lead to prolonged muscle soreness and even to excessive muscle damage. Low level laser therapy (LLLT) is among novel methods for preventing and treating of exercise induced muscle damage and soreness. This is the first randomised, double blind crossover trial to evaluate effects of LLLT on muscle fatigue and recovery after a single session of NMES in healthy, moderately active men.
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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
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A/Prof Maciej Plaszewski
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Address
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Józef Pilsudski University of Physical Education, Department of Health Sciences in Biala Podlaska, Akademicka 2, 21-500 Biala Podlaska
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Country
92762
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Poland
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Phone
92762
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+48 83 3428700
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Maciej Plaszewski
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Address
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Józef Pilsudski University of Physical Education, Department of Health Sciences in Biala Podlaska, Akademicka 2, 21-500 Biala Podlaska
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Country
92763
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Poland
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Phone
92763
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+48 83 3428700
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Fax
92763
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Email
92763
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Maciej Plaszewski
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Address
92764
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Józef Pilsudski University of Physical Education, Department of Health Sciences in Biala Podlaska, Akademicka 2, 21-500 Biala Podlaska
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Country
92764
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Poland
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Phone
92764
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+48 83 3428700
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Fax
92764
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Email
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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?
Individual participant data underlying published results only.
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When will data be available (start and end dates)?
Immediately following publication, no end date.
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Available to whom?
Only researchers who provide a methodologically sound proposal, on case-by-case basis.
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Available for what types of analyses?
Only to achieve the aims in the approved proposal.
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How or where can data be obtained?
Access subject to approvals by Principal Investigator, with requirement to sign data access agreement.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1918
Informed consent form
377426-(Uploaded-18-04-2019-20-28-57)-Study-related document.pdf
1919
Ethical approval
377426-(Uploaded-18-04-2019-20-38-33)-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
The effect of low level laser irradiation on oxidative stress, muscle damage and function following neuromuscular electrical stimulation. A double blind, randomised, crossover trial.
2019
https://dx.doi.org/10.1186/s13102-019-0147-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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