Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000633886
Ethics application status
Not yet submitted
Date submitted
29/05/2012
Date registered
13/06/2012
Date last updated
13/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of laser Therapy on delayed Muscle pain after exercise
Scientific title
Effects of Low Level Laser Therapy (LLLT) on Delayed Onset Muscle Soreness (DOMS) in healthy males aged 18 to 28 years enrolled in recreational sports
Secondary ID [1] 280525 0
NIL
Universal Trial Number (UTN)
U1111-1130-9505
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
DOMS after eccentric exercise protocol 286516 0
Condition category
Condition code
Musculoskeletal 286780 286780 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low level laser therapy (LLLT)
The irradiation will be performed in contact mode with the laser probe held stationary with slight pressure at a 90 degrees angle on each of the three treatment points and to do the LLLT irradiations in the same biceps area for each participant, a template will be utilized. The three treatments points will be along the muscle belly of brachii biceps and each application of laser will be approximately 45 seconds. . Each subject will receive two irradiations, in the same day, with either active LLLT or placebo LLLT, finishing 5 minutes before and commencing 5 minutes after the eccentric exercise protocol. The laser parameters are: 830 nm infrared wavelength (GaAlAs), continuous wave output, optical output of 110 mW, spot size of 78 mm2, energy of 5 J per point, 12 points of irradiation, total energy of 60 J, energy density of 0,64 J/cm2. The eccentric exercise protocol will be realized in a isokinect dynamometer with the participants seated and using the elbow/sholder attachment; three sets with 20 repetions of elbow contraction and extension, with an intensity corresponding to 80% of their predertermined maximal voluntary contraction (MVC).
Intervention code [1] 284898 0
Treatment: Devices
Intervention code [2] 285068 0
Prevention
Comparator / control treatment
Placebo. The placebo group will be treated with un-activated low level laser therapy during the same time that the activated laser light.
Control group
Placebo

Outcomes
Primary outcome [1] 287157 0
Maximum voluntary contraction (MVC) test
Timepoint [1] 287157 0
The MVC test will be carried on eight time: one week before the exercise protocol; immediately before and after exercise protocol; after 24 hs, 48 hs, 72 hs, 144hs and 196 hs of exercise.
Primary outcome [2] 287158 0
Range of Motion. The range of motion (ROM) will be determined for the goniometer to measure the angle between the humerus and the radius. A semi-permanent marker will be used to identify the lateral middle point of the humerus, the lateral axis point of elbow joint, and the lateral middle point between radius and ulna. Flexed elbow joint angle (FANG) will be determined when the participant was asked to fully flex the elbow joint by touching his palm to the shoulder. Relaxed elbow joint angle (RANG) will be the angle when the elbow was extended (Chen et al. 2009).
Timepoint [2] 287158 0
The ROM will be evaluated during seven occasions: one week before the exercise protocol, immediatly after the eccentric exercise, after 24 hs, 48 hs, 72 hs, 144hs and 196 hs of exercise.
Secondary outcome [1] 297520 0
Pain
Timepoint [1] 297520 0
The algometry will be pressed against the biceps muscle skin until the participant report pain. Pressure pain algometry will be evaluated on each of 7 occasions: one week before the exercise protocol; immediatly after the exercise; after 24 hs, 48 hs, 72 hs, 144hs and 196 hs of exercise.
Secondary outcome [2] 297521 0
creatine kinase (CK), lactate desidrogenase (LD), IL-8 and IL-6 levels through the blood samples analysis. PhD candidate Natalia Rodrigues will be undertaking the phlebotomy for blood samples. Mrs Rodrigues is
therefore currently undertaking the phlebotomist training course under the direction of certified trainer Dr
Andrew Bulmer (Griffith University), in conjunction with the Gold Coast Hospital.
Timepoint [2] 297521 0
The blood samples will be taken before the exercise protocol and at the following time points: one week before the exercise protocol; immediatly after the exercise; after 24 hs, 48 hs, 72 hs, 144hs and 196 hs of exercise.
Secondary outcome [3] 297637 0
Muscle biopsies (for analysis of muscle
morphology and later analysis of mitochondrial function).
Timepoint [3] 297637 0
Muscle biopsies will be extracted from a sub-group of
consenting participants at two time points (1 week before and 24 hs after the exercise event at the usual peak of symptoms).

Eligibility
Key inclusion criteria
The inclusion criteria will be: healthy males aged between 18 and 28 years enrolled in recreational sports, but not competing at any specific level. They will not be enrolled in strength training programs and will not be users of nutritional supplements. Participants with a body mass index (BMI) between 20 and 25 Kg/m2 will be selected to take part in the study.
Minimum age
18 Years
Maximum age
28 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria will be: any previous injury to the shoulder or elbow, cardiovascular system disorders, systemic disease and taking prescription medicines or using dietary supplements. Participants, who do not comply with the training routine, miss the training sessions or develop any osseous or muscle or articular injuries 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)
Participants will be randomly allocated to one of two groups: Group 1: eccentric exercise protocol plus sham laser before and after the exercise protocol; and Group 2: eccentric exercise protocol plus laser irradiation before and after the exercise protocol. This division will be done one day before the eccentric exercise protocol, without the participants and the researchers knowledge. Because the division will occur using a computerised random number generator freely available on line (Randomizer.org). However, the researchers will determine who is eligible for inclusion in the trial until complete 10 subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to one of two groups: Group 1: eccentric exercise protocol plus sham
laser before and after the exercise protocol; and Group 2: eccentric exercise protocol plus laser irradiation
before and after the exercise protocol.
Randomisation will occur using a computerised random number generator freely available on line
(Randomizer.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The effect of this relationship will be minimised by the fact that the recruitment, screening and consent
process will be conducted by the PhD student (Ms Rodrigues). n order to blind the assessor (Ms Rodrigues) A/Prof Laakso will apply the laser and sham laser to all
participants. Other than this contact, A/Prof Laakso will have no further involvement with participants.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285285 0
University
Name [1] 285285 0
Griffith University
Country [1] 285285 0
Australia
Primary sponsor type
Individual
Name
A/Prof Liisa Laakso
Address
School of Physiotherapy and Exercise Science

Gold Coast Campus,

Griffith University Queensland 4222
Country
Australia
Secondary sponsor category [1] 284145 0
Charities/Societies/Foundations
Name [1] 284145 0
Coordenacao de aperfeicoamento de pessoal de nivel superior - CAPES
Address [1] 284145 0
Setor Bancario Norte, Quadra 2, Bloco L, Lote 06, CEP: 70040-020 - Brasilia, DF.
Country [1] 284145 0
Brazil

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287300 0
Griffith University Human Research Ethics Committee (EC00162)
Ethics committee address [1] 287300 0
Ethics committee country [1] 287300 0
Australia
Date submitted for ethics approval [1] 287300 0
24/05/2012
Approval date [1] 287300 0
Ethics approval number [1] 287300 0

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

Contacts
Principal investigator
Name 34204 0
Address 34204 0
Country 34204 0
Phone 34204 0
Fax 34204 0
Email 34204 0
Contact person for public queries
Name 17451 0
Natalia Camargo Rodrigues
Address 17451 0
School of Physiotherapy and Exercise Science

Gold Coast Campus,

Griffith University Queensland 4222
Country 17451 0
Australia
Phone 17451 0
+61 0498107416
Fax 17451 0
Email 17451 0
[email protected]
Contact person for scientific queries
Name 8379 0
A/Prof Liisa Laakso
Address 8379 0
School of Physiotherapy and Exercise Science

Gold Coast Campus,

Griffith University Queensland 4222
Country 8379 0
Australia
Phone 8379 0
+61 7 5552 9122
Fax 8379 0
Email 8379 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.