FatigueNCT02813395
Laser Therapy on Neuromuscular Performance
A study testing Low Level Laser Therapy in people with Fatigue, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Presenting pain that prevented the completion of the evaluation, subjects whose data were improperly recorded or if the volunteer withdrew from the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59140-840
About this study
Official title: Immediate Effects of Low-level Laser Therapy (808nm) on Neuromuscular Performance After Muscle Fatigue: Randomized-blinded Clinical Trial
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.
- Conditions
- Fatigue
- Being tested
- Low Level Laser Therapy, Placebo Laser
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
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 LaserDevice
Laser application simulation with a second pen of the laser device, which was disconnected and did not effectively irradiate energy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Placebo Laser |
| Laser before | Experimental | Volunteers received effective application of laser before fatigue protocol. Receives: Device: Low Level Laser Therapy |
| Laser after | Experimental | Volunteers received effective application of laser after fatigue protocol. Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak torque normalized by body weight
Measured: Change from baseline to one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813395
- Sponsor's protocol ID
- RMV2016
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Low-level Laser Therapy (808nm) on Neuromuscular Performance After Muscle Fatigue: Randomized-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02813395
- Acronym / sponsor ID
- RMV2016
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Volunteers remained at rest before and after the fatigue protocol. |
| Placebo group | Placebo comparator | Device: Placebo LaserVolunteers 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. |
| Laser before | Experimental | Device: Low Level Laser TherapyVolunteers received effective application of laser before fatigue protocol. |
| Laser after | Experimental | Device: Low Level Laser TherapyVolunteers received effective application of laser after fatigue protocol. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Presenting pain that prevented the completion of the evaluation, subjects whose data were improperly recorded or if the volunteer withdrew from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyLow 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. | Device | Laser after, Laser before |
| Placebo LaserLaser application simulation with a second pen of the laser device, which was disconnected and did not effectively irradiate energy. | Device | Placebo group |
Primary outcome
Peak torque normalized by body weight
Time frame: Change from baseline to one hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Fatigue, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak torque normalized by body weight (time frame: Change from baseline to one hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.