Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low level laser therapy
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Photobiomodulation
Eligibility Criteria
Inclusion Criteria:
- Individuals of both sexes;
- Over 18 years of age;
- With a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 2 years according to the criteria of the clinically stable Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), free of disease exacerbation in the last 30 days;
- Performing routine outpatient treatment with a pulmonologist;
- Agreement to participate.
Exclusion Criteria:
- Individuals with other comorbidities, such as: Acute Lung Disease, Congestive Heart Failure, Liver Failure, Pulmonary Thromboembolism, Acute Respiratory Distress Syndrome, Neoplasms, HIV Positive, Immunodeficiency, Blood Disorders, Septicemia or recent major surgery.
- Patients with cystic fibrosis and Kartagner's syndrome.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control group
Laser group
Arm Description
Outcomes
Primary Outcome Measures
Measure of functional capacity
Walk test: In a flat hallway, it will be delimited by two cones and the patient will be guided to walk from one side to the other. The walking speed will be controlled by a "compact disc" that emits beeps (simple BIP) at regular intervals. The test will be interrupted by exhaustion or when the patient is unable to maintain the proposed speed.
Secondary Outcome Measures
TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α
Quantification of serum levels of interleukin will be performed using Human IL-10 and THF-alpha ELISA MAX (Biolegend) according to the manufacturer's instructions. Briefly, the plates will be coated with anti-IL-10 or anti-TNF-alpha capture monoclonal antibody for 18 h at 8 ° C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2 h and after washing, the detection antibody solution will be added. The reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm. They will be evaluated immediately after the end of treatment.
Spirometry
The spirometry test will be performed by a physiotherapist using a spirometer apparatus to perform spirometry before and after 20 minutes of bronchodilator administration. The technical procedures, the criteria of acceptability and reproducibility adopted will be those recommended by the Brazilian Consensus of Spirometry. All patients will perform the maneuvers after bronchodilator (salbutamol 400 μg inhalation). They will be evaluated immediately after the end of treatment.
Quality of life assessment questionnaire
Saint George's Respiratory Questionnaire (SGRQ): We apply questions related to daily life activities related to the quality of life of patients with COPD. They will be evaluated immediately after the end of treatment.
The SGRQ addresses aspects related to three areas:
symptoms, activity and psychosocial impacts that respiratory disease inflicts on the patient. Each domain has a maximum possible score; the points of each answer are summed and the total is referred to as a percentage of this maximum.
Full Information
NCT ID
NCT04010084
First Posted
April 25, 2019
Last Updated
July 4, 2019
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT04010084
Brief Title
Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease
Official Title
Effectiveness of Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease - Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
June 3, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic obstructive pulmonary disease (COPD) is among the most common chronic respiratory diseases (CKD). Millions of people of all ages suffer from these diseases. COPD is between the fifth and sixth of the leading causes of death in Brazil. It generates an inflammatory pulmonary response that is softened by non-curative treatments and that present serious side effects. Low intensity laser (LBI) or laser therapy has been used for about 50 years to help the healing process, revealing efficient anti-inflammatory and analgesic responses, as well as experimental models of acute and chronic inflammation. However, little is known about its response in inflammatory lung diseases, especially COPD. Some reports indicate that laser therapy may interfere positively by relieving clinical signs, the onset, and the final symptoms of pulmonary inflammation. The present project aims to study the effects of LBI on Chronic Obstructive Pulmonary Disease in patients with pulmonary processes, determine their mechanisms of action and evaluate its effect on patients' functional capacity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Photobiomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
the participant will be randomized through a raffle without knowing which group has the active intervention or placebo.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Title
Laser group
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Low level laser therapy
Intervention Description
The irradiation will be applied transcutaneously in the sublingual region (3 points on the left side and 3 points on the right side), irradiated for 30 seconds and the total treatment time will be 3 minutes. The group will receive irradiation with a DMC-branded laser EC device, with combined wavelength (660 and 780 nm), 1J of energy per point and output power of 35 mW. A disposable plastic material covering the application pen will be used for hygiene reasons.
The treatment will be performed twice weekly for a total of 4 consecutive weeks of treatment, and after completion, the patients will be reassessed of all the complementary tests that have been requested.
Intervention Type
Procedure
Intervention Name(s)
Placebo group
Intervention Description
The irradiation will be applied transcutaneously in the sublingual region (3 points on the left side and 3 points on the right side), irradiated for 30 seconds and the total treatment time will be 3 minutes. The group will receive placebo (with switched-off) irradiation of the DMC-brand laser therapy EC model, with combined wavelength (660 and 780 nm), 1J of energy per point and output power of 35 mW. A disposable plastic material covering the application pen will be used for hygiene reasons.
The treatment will be performed twice weekly for a total of 4 consecutive weeks of treatment, and after completion, the patients will be reassessed of all the complementary tests that have been requested.
Primary Outcome Measure Information:
Title
Measure of functional capacity
Description
Walk test: In a flat hallway, it will be delimited by two cones and the patient will be guided to walk from one side to the other. The walking speed will be controlled by a "compact disc" that emits beeps (simple BIP) at regular intervals. The test will be interrupted by exhaustion or when the patient is unable to maintain the proposed speed.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α
Description
Quantification of serum levels of interleukin will be performed using Human IL-10 and THF-alpha ELISA MAX (Biolegend) according to the manufacturer's instructions. Briefly, the plates will be coated with anti-IL-10 or anti-TNF-alpha capture monoclonal antibody for 18 h at 8 ° C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2 h and after washing, the detection antibody solution will be added. The reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm. They will be evaluated immediately after the end of treatment.
Time Frame
4 weeks
Title
Spirometry
Description
The spirometry test will be performed by a physiotherapist using a spirometer apparatus to perform spirometry before and after 20 minutes of bronchodilator administration. The technical procedures, the criteria of acceptability and reproducibility adopted will be those recommended by the Brazilian Consensus of Spirometry. All patients will perform the maneuvers after bronchodilator (salbutamol 400 μg inhalation). They will be evaluated immediately after the end of treatment.
Time Frame
4 weeks
Title
Quality of life assessment questionnaire
Description
Saint George's Respiratory Questionnaire (SGRQ): We apply questions related to daily life activities related to the quality of life of patients with COPD. They will be evaluated immediately after the end of treatment.
The SGRQ addresses aspects related to three areas:
symptoms, activity and psychosocial impacts that respiratory disease inflicts on the patient. Each domain has a maximum possible score; the points of each answer are summed and the total is referred to as a percentage of this maximum.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals of both sexes;
Over 18 years of age;
With a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 2 years according to the criteria of the clinically stable Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), free of disease exacerbation in the last 30 days;
Performing routine outpatient treatment with a pulmonologist;
Agreement to participate.
Exclusion Criteria:
Individuals with other comorbidities, such as: Acute Lung Disease, Congestive Heart Failure, Liver Failure, Pulmonary Thromboembolism, Acute Respiratory Distress Syndrome, Neoplasms, HIV Positive, Immunodeficiency, Blood Disorders, Septicemia or recent major surgery.
Patients with cystic fibrosis and Kartagner's syndrome.
12. IPD Sharing Statement
Learn more about this trial
Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease
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