Effects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals

July 12, 2019 updated by: Universidade do Vale do Paraíba

Analysis of the Effects of Low-level Laser Therapy in the Muscular Fadiga of the Braquial Biceps Muscle of Healthy Individual and Spastic Individuals

Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction. The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis. The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization. The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. Will be evaluated pain, myoelectric activity associated with muscular torque, local temperature and blood lactate concentration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction. Several resources are studied in order to mitigate this situation, among them we can mention the Low Level-Laser Therapy (LLLT), which has demonstrated positive effects in the treatment of muscle disorders and fatigue prevention. The effects of LLLT are being studied in healthy individuals with fibromyalgia and athletes, currently studies are being performed on spastic muscles with post-stroke patients (post-stroke). The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis. A double-blind, cross-sectional, comparative, randomized, double-blind clinical trial will be conducted. Phase I will consist of 30 healthy individuals and Phase II will be composed of 30 post-stroke individuals. The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization. The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. The pain intensity will be evaluated through the Visual Analog Pain Scale, the myoelectric activity through the surface electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer. The local temperature will be evaluated by infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São José Dos Campos, São Paulo, Brazil, 12.244-000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • Inclusion Criteria (Healthy group):

    • Preserved cognition, and preservation of the ability to respond to verbal stimul;
    • To present the "insufficient active" or "active" indices on the scale of the International Questionnaire of Physical Activity.

  • Inclusion Criteria (Post stroke group):

    • Individuals with medical diagnosis of stroke;
    • Individuals with physiotherapeutic diagnosis of spastic hemiparesis with brachial predominance;
    • Preserved cognition and preservation of the ability to respond to verbal stimuli;
    • Injury time: after 12 months;
    • Patients with a maximum of 2 degree spasticity according to the Modified Ashworth Scale and minimum muscle strength of 1 in the biceps brachii muscle.

  • Exclusion Criteria (Healthy group):

    • Possess musculoskeletal impairment of the dominant upper limb;
    • Practice physical activity with load (bodybuilding);
    • Presence of active infection and eruptions in the dominant upper limb;
    • Limiting pain that makes it impossible to perform the evaluation protocol;
    • Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing corticosteroids or steroids.
    • Fitzpatrick classification: Phototypes V and VI;
    • Presence of malignant neoplastic lesion;
    • Presence of active infection and eruptions at the electrode application site;
    • Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb in which TLBI will be applied.

  • Exclusion Criteria (Healthy group):

    • Presence of active infection and eruptions in the dominant upper limb;
    • Limiting pain that makes it impossible to perform the evaluation protocol;
    • Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing corticosteroids or steroids.
    • Fitzpatrick classification: Phototypes V and VI;
    • Presence of malignant neoplastic lesion;
    • Presence of active infection and eruptions at the electrode application site;
    • Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb to be treated;
    • Muscular contractures and joint deformities;
    • Uncontrolled arterial hypertension;
    • Individuals with other associated neurological and / or orthopedic disorders;
    • Wernick or Broca's aphasia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Healthy group
The protocol consists of Low-level laser therapy (LLLT) application in the dominant side brachialis muscle in healthy subjects prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).
Other: Low-level laser therapy
In both arms will be applied Low-level laser therapy and induced muscle fatigue.
EXPERIMENTAL: Post stroke group
The protocol consists of Low-level laser therapy (LLLT) application in the hemiparetic side brachialis muscle post stroke individuals prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, surface electromyography with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).
Other: Low-level laser therapy
In both arms will be applied Low-level laser therapy and induced muscle fatigue.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in pain sensation
Time Frame: Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
To analize the pain. The scale is composed of a horizontal line with a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.
Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
Surface electromyograph
Time Frame: Will be assessed from the beginning to the end of the test (50 seconds).
To analize the myoelectric activity. The surface electrodes will be placed in pairs on the muscular belly of the biceps and triceps brachii muscles, following the longitudinal direction of the muscle fibers.
Will be assessed from the beginning to the end of the test (50 seconds).
Analyze the behavior of the local temperature (Infra-red thermography)
Time Frame: Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
To analize the local temperature.
Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
To evaluate changes in lactate concentration through lactimeter.
Time Frame: Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
A collection of blood lactate levels will be performed at four different times.
Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
Isokinetic dynamometer
Time Frame: Will be assessed from the beginning to the end of the test (50 seconds).
To analize muscle torque
Will be assessed from the beginning to the end of the test (50 seconds).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Vale do Paraíba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fernanda P Lima, Doctor, Universidade do Vale do Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNIVAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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