Muscle DamageNCT02493556
Effect of Low-level Laser Therapy on Exercise-induced Muscle Damage
A study testing LLLT before muscle damage and LLLT after muscle damage in people with Muscle Damage, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular damage have been studied over the last years. Studies have been conducted on animals and humans in order to try to show the benefits of the intervention, but there is still conflicting evidence about its protective and therapeutic… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- LLLT before muscle damage and LLLT after muscle damage
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Sep 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged between 18 and 35 years;
- Sedentary or physically active individuals who exercise up to 3 times per week.
Who cannot join
- Individuals who participate in systematic exercise training;
- Individuals who participate in strength training for the lower limbs;
- Individuals with lower or upper limb injuries;
- Individuals with contra-indications to maximal exercise performance (due to neurological, cardiovascular or respiratory conditions);
- Individuals who show difficulties to understand the study protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Science of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: Effect of Low-level Laser Therapy on Exercise-induced Muscle Damage: a Randomized Clinical Trial
Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular damage have been studied over the last years. Studies have been conducted on animals and humans in order to try to show the benefits of the intervention, but there is still conflicting evidence about its protective and therapeutic effects.
Objectives: To describe the effects of LLLT on pain, strength and muscular inflammation after plyometric exercise.
Methods: A randomized, double-blinded, placebo-controlled trial with participation of 20 male healthy volunteers will be performed. Healthy and physically active individuals, aged between 18 and 35 years, with no history of injury on the lower limbs or contra-indications to maximal exercise performance will be included. A protocol of 10 series with 10 repetitions of the countermovement jump will be used to induce muscle damage at the lower limbs. Immediately before or after the exercise protocol, LLLT will be applied on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with 5 diodes on 8 different points of the knee extensor muscle, totalizing a dosage of 240J. The placebo treatment will be held on the same way, but the equipment will be turned off. The volunteers will be evaluated at baseline (before the exercise protocol) and at follow-up of 24, 48 and 72 hours. The following outcomes will be evaluated: knee extensors isometric peak torque by Isokinetic Dynamometer, pain by Visual Analogue Scale and muscular tissue echo intensity by Ultrasonography.
- Conditions
- Muscle Damage
- Being tested
- LLLT before muscle damage, Placebo LLLT before muscle damage, LLLT after muscle damage, Placebo LLLT after muscle damage
- Keywords
- Phototherapy, Plyometric exercise, Muscle recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLT before muscle damageDevice
Placebo LLLT before muscle damageDevice
LLLT after muscle damageDevice
Placebo LLLT after muscle damageDevice
| Study group | Role | What they receive |
|---|---|---|
| LLLT before muscle damage | Experimental | Low Level Laser Therapy (LLLT) will be applied before the exercise protocol on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with five diodes on eight different points of quadriceps muscle, totalizing a dosage of 240J. Receives: Device: LLLT before muscle damage |
| Placebo LLLT before muscle damage | Placebo comparator | Placebo LLLT will be applied before the exercise protocol on one lower limb, while the other will receive real treatment. Placebo treatment will also be applied on eight different points of quadriceps muscle, but the equipment will be turned off. Receives: Device: Placebo LLLT before muscle damage |
| LLLT after muscle damage | Active comparator | Low Level Laser Therapy (LLLT) will be applied after the exercise protocol on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with five diodes on eight different points of quadriceps muscle, totalizing a dosage of 240J. Receives: Device: LLLT after muscle damage |
| Placebo LLLT after muscle damage | Placebo comparator | Placebo LLLT will be applied after the exercise protocol on one lower limb, while the other will receive real treatment. Placebo treatment will also be applied on eight different points of quadriceps muscle, but the equipment will be turned off. Receives: Device: Placebo LLLT after muscle damage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extensors isometric peak torque (Nm)
Isokinetic Dynamometer
Measured: Baseline and 24, 48 and 72 hours follow-up
Secondary outcomes (2)
Knee extensors soreness (Visual Analogue scale)
Measured: Baseline and 24, 48 and 72 hours follow-up
Knee extensors echo intensity (number of white and black pixels)
Measured: Baseline and 24, 48 and 72 hours follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre
- Investigators
- Bruno Baroni, phD, Study director, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493556
- Sponsor's protocol ID
- 38076514.0.0000.5345
- Status last verified
- Jul 2015
- First submitted
- 7 Jul 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy on Exercise-induced Muscle Damage: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02493556
- Acronym / sponsor ID
- 38076514.0.0000.5345
- Conditions
- Muscle Damage
- Keywords
- Phototherapy, Plyometric exercise, Muscle recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jul 2015 (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.
Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular damage have been studied over the last years. Studies have been conducted on animals and humans in order to try to show the benefits of the intervention, but there is still conflicting evidence about its protective and therapeutic effects.
Objectives: To describe the effects of LLLT on pain, strength and muscular inflammation after plyometric exercise.
Methods: A randomized, double-blinded, placebo-controlled trial with participation of 20 male healthy volunteers will be performed. Healthy and physically active individuals, aged between 18 and 35 years, with no history of injury on the lower limbs or contra-indications to maximal exercise performance will be included. A protocol of 10 series with 10 repetitions of the countermovement jump will be used to induce muscle damage at the lower limbs. Immediately before or after the exercise protocol, LLLT will be applied on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with 5 diodes on 8 different points of the knee extensor muscle, totalizing a dosage of 240J. The placebo treatment will be held on the same way, but the equipment will be turned off. The volunteers will be evaluated at baseline (before the exercise protocol) and at follow-up of 24, 48 and 72 hours. The following outcomes will be evaluated: knee extensors isometric peak torque by Isokinetic Dynamometer, pain by Visual Analogue Scale and muscular tissue echo intensity by Ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LLLT before muscle damage | Experimental | Device: LLLT before muscle damageLow Level Laser Therapy (LLLT) will be applied before the exercise protocol on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with five diodes on eight different points of quadriceps muscle, totalizing a dosage of 240J. |
| Placebo LLLT before muscle damage | Placebo comparator | Device: Placebo LLLT before muscle damagePlacebo LLLT will be applied before the exercise protocol on one lower limb, while the other will receive real treatment. Placebo treatment will also be applied on eight different points of quadriceps muscle, but the equipment will be turned off. |
| LLLT after muscle damage | Active comparator | Device: LLLT after muscle damageLow Level Laser Therapy (LLLT) will be applied after the exercise protocol on one lower limb, while the other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm and a cluster with five diodes on eight different points of quadriceps muscle, totalizing a dosage of 240J. |
| Placebo LLLT after muscle damage | Placebo comparator | Device: Placebo LLLT after muscle damagePlacebo LLLT will be applied after the exercise protocol on one lower limb, while the other will receive real treatment. Placebo treatment will also be applied on eight different points of quadriceps muscle, but the equipment will be turned off. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males aged between 18 and 35 years;
- Sedentary or physically active individuals who exercise up to 3 times per week.
Key exclusion criteria (5 listed)
- Individuals who participate in systematic exercise training;
- Individuals who participate in strength training for the lower limbs;
- Individuals with lower or upper limb injuries;
- Individuals with contra-indications to maximal exercise performance (due to neurological, cardiovascular or respiratory conditions);
- Individuals who show difficulties to understand the study protocol.
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 |
|---|---|---|
| LLLT before muscle damage | Device | LLLT before muscle damage |
| Placebo LLLT before muscle damage | Device | Placebo LLLT before muscle damage |
| LLLT after muscle damage | Device | LLLT after muscle damage |
| Placebo LLLT after muscle damage | Device | Placebo LLLT after muscle damage |
Primary outcome
Knee extensors isometric peak torque (Nm)
Time frame: Baseline and 24, 48 and 72 hours follow-up
Isokinetic Dynamometer
2 secondary outcomes
Knee extensors soreness (Visual Analogue scale)
Time frame: Baseline and 24, 48 and 72 hours follow-up
Knee extensors echo intensity (number of white and black pixels)
Time frame: Baseline and 24, 48 and 72 hours follow-up
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 15 Oct 2015.
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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.
Bruno Baroni, phD study director
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLLT before muscle damage and LLLT after muscle damage in people with Muscle Damage, run by Federal University of Health Science of Porto Alegre 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 2 inclusion and 5 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 15 Oct 2015. 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?
Knee extensors isometric peak torque (Nm) (time frame: Baseline and 24, 48 and 72 hours follow-up). 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 15 Oct 2015.