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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 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
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
Secondary ID [1] 298004 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delayed onset muscle soreness (DOMS) 312454 0
exercise induced muscle damage (EIMD) 312455 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311003 311003 0 0
Physiotherapy
Musculoskeletal 311004 311004 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314235 0
Treatment: Other
Comparator / control treatment
Sham therapy. (identical to LLLT intervention except the light outputs of the probe covered with aluminium foil).
Control group
Placebo

Outcomes
Primary outcome [1] 319811 0
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.
Timepoint [1] 319811 0
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.
Primary outcome [2] 319812 0
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.
Timepoint [2] 319812 0
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.
Secondary outcome [1] 369588 0
Redox parameter 1: the activity of superoxide dismutase (SOD) in erythrocytes, determined with commercially available kits (RANSOD Cat. No. SD 125; Randox, Crumlin, UK).
Timepoint [1] 369588 0
Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
Secondary outcome [2] 369589 0
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).
Timepoint [2] 369589 0
Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
Secondary outcome [3] 369845 0
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).
Timepoint [3] 369845 0
Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
Secondary outcome [4] 369846 0
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).
Timepoint [4] 369846 0
Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
Secondary outcome [5] 369847 0
Concentration of uric acid (UA) in plasma, determined with the use of a diagnostic kit Cat. No. C6512-100, Alpha Diagnostics, Poland.
Timepoint [5] 369847 0
Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
Secondary outcome [6] 369848 0
Concentration of C-reactive protein (CRP) in plasma; determined with the use of a diagnostic kit Cat. No. K6580-200, Alpha Diagnostics, Poland.
Timepoint [6] 369848 0
Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.
Secondary outcome [7] 369849 0
Creatine kinase (CK) activity in plasma, determined with the use of a diagnostic kit Cat. No. C6428-075, Alpha Diagnostics, Poland.
Timepoint [7] 369849 0
Assessed at multiple timepoints: immediately (0), 24, 48, 72 and 96 hours after electrical stimulation (NMES) session.

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.
Minimum age
20 Years
Maximum age
24 Years
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed.
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),
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
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2015
Date of last participant enrolment
Anticipated
Actual
25/05/2015
Date of last data collection
Anticipated
Actual
20/08/2016
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 21422 0
Poland
State/province [1] 21422 0
lubelskie voivodship

Funding & Sponsors
Funding source category [1] 302528 0
University
Name [1] 302528 0
Józef Pilsudski University of Physical Education, Warsaw
Country [1] 302528 0
Poland
Primary sponsor type
University
Name
Józef Pilsudski University of Physical Education, Warsaw
Address
Marymoncka 34, 00-968 Warszawa
Country
Poland
Secondary sponsor category [1] 302440 0
None
Name [1] 302440 0
Nil
Address [1] 302440 0
Nil
Country [1] 302440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303179 0
The Research Ethics Committee, University of Physical Education, Warsaw, Poland
Ethics committee address [1] 303179 0
Ethics committee country [1] 303179 0
Poland
Date submitted for ethics approval [1] 303179 0
Approval date [1] 303179 0
26/06/2014
Ethics approval number [1] 303179 0
SKE 01-14/2014

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

Contacts
Principal investigator
Name 92762 0
A/Prof Maciej Plaszewski
Address 92762 0
Józef Pilsudski University of Physical Education, Department of Health Sciences in Biala Podlaska, Akademicka 2, 21-500 Biala Podlaska
Country 92762 0
Poland
Phone 92762 0
+48 83 3428700
Fax 92762 0
Email 92762 0
maciej.plaszewski@awf-bp.edu.pl
Contact person for public queries
Name 92763 0
Maciej Plaszewski
Address 92763 0
Józef Pilsudski University of Physical Education, Department of Health Sciences in Biala Podlaska, Akademicka 2, 21-500 Biala Podlaska
Country 92763 0
Poland
Phone 92763 0
+48 83 3428700
Fax 92763 0
Email 92763 0
maciej.plaszewski@awf-bp.edu.pl
Contact person for scientific queries
Name 92764 0
Maciej Plaszewski
Address 92764 0
Józef Pilsudski University of Physical Education, Department of Health Sciences in Biala Podlaska, Akademicka 2, 21-500 Biala Podlaska
Country 92764 0
Poland
Phone 92764 0
+48 83 3428700
Fax 92764 0
Email 92764 0
maciej.plaszewski@awf-bp.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal, on case-by-case basis.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, with requirement to sign data access agreement.


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    377426-(Uploaded-18-04-2019-20-28-57)-Study-related document.pdf
Ethical approval    377426-(Uploaded-18-04-2019-20-38-33)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of low level laser irradiation on oxidative stress, muscle damage and function following neuromuscular electrical stimulation. A double blind, randomised, crossover trial.2019https://dx.doi.org/10.1186/s13102-019-0147-3
N.B. These documents automatically identified may not have been verified by the study sponsor.