NCT02813395

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

June 21, 2016

Last Update Submit

June 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Peak torque normalized by body weight

    Change from baseline to one hour.

Study Arms (4)

Control group

NO INTERVENTION

Volunteers remained at rest before and after the fatigue protocol.

Placebo group

PLACEBO COMPARATOR

Volunteers were subjected to laser application simulation for approximately four minutes with a second pen of the laser device, which was disconnected and did not effectively irradiate energy.

Device: Placebo Laser

Laser before

EXPERIMENTAL

Volunteers received effective application of laser before fatigue protocol.

Device: Low Level Laser Therapy

Laser after

EXPERIMENTAL

Volunteers received effective application of laser after fatigue protocol.

Device: Low Level Laser Therapy

Interventions

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.

Laser afterLaser before

Laser application simulation with a second pen of the laser device, which was disconnected and did not effectively irradiate energy.

Placebo group

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59140-840, Brazil

Location

MeSH Terms

Conditions

Fatigue

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 27, 2016

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations