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Clinical Trials/NCT03753984
NCT03753984UnknownNot Applicable

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

Universidade do Vale do Paraíba2 sites in 1 country50 target enrollmentStarted: September 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
To evaluate changes in lactate concentration through lactimeter.

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

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.

Isokinetic dynamometer

Time Frame: Will be assessed from the beginning to the end of the test (50 seconds).

To analize muscle torque

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Universidade do Vale do Paraíba
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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