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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02813395
Other study ID # RMV2016
Secondary ID
Status Completed
Phase N/A
First received June 21, 2016
Last updated June 24, 2016
Start date April 2014
Est. completion date August 2015

Study information

Verified date June 2016
Source Universidade Federal do Rio Grande do Norte
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

Objective: Investigating the immediate effects of Low Level Laser Therapy (LLLT) on neuromuscular performance in healthy subjects after an induced muscle fatigue protocol. Methods: Eighty volunteers of both genders aged between 18 and 28 years underwent a preliminary evaluation using surface electromyography and isokinetic dynamometer of the flexor muscles of the elbow. The subjects were randomly allocated into 4 groups: G1 was control group; G2 placebo; G3 laser applied before fatigue protocol; and G4 immediately after. Muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions at 120°/s of the elbow flexor muscles. An 808 nm equipment was used for applying laser therapy, with a power of 100 mW and total energy of 20 J. Volunteers were reassessed after interventions.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date August 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria:

- Being between 18-28 years of age, having no pain in the shoulder area, elbow or hand, and not having suffered any to injury to the assessed upper limb in the last six months.

Exclusion Criteria:

- Presenting pain that prevented the completion of the evaluation, subjects whose data were improperly recorded or if the volunteer withdrew from the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Device:
Low Level Laser Therapy
Low Level Laser Therapy was applied at four points to the dominant upper limb of the volunteers on the muscle belly of the biceps. Delineation was done using a measuring tape from the elbow joint line to the acromion marked at points corresponding to 20%, 30%, 40% and 50% of this distance, focusing the application on the muscle belly region, thereby excluding the tendinous region. An 808 nm equipment was used for applying laser therapy, with a power of 100 mW and total energy of 20 J.
Placebo Laser
Laser application simulation with a second pen of the laser device, which was disconnected and did not effectively irradiate energy.

Locations

Country Name City State
Brazil Federal University of Rio Grande do Norte Natal RN

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak torque normalized by body weight Change from baseline to one hour. Yes
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