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Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT04010084
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Radiation: Low level laser therapy Procedure: Placebo group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: the participant will be randomized through a raffle without knowing which group has the active intervention or placebo.
Primary Purpose: Treatment
Official Title: Effectiveness of Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease - Randomized Clinical Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : June 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Placebo Comparator: Control group Procedure: Placebo group

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.


Active Comparator: Laser group Radiation: Low level laser therapy

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.





Primary Outcome Measures :
  1. Measure of functional capacity [ Time Frame: 4 weeks ]
    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 :
  1. TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α [ Time Frame: 4 weeks ]
    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.

  2. Spirometry [ Time Frame: 4 weeks ]
    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.

  3. Quality of life assessment questionnaire [ Time Frame: 4 weeks ]

    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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT04010084    
Other Study ID Numbers: OliverDPOC
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandra Kalil Bussadori, University of Nove de Julho:
Chronic Obstructive Pulmonary Disease
Photobiomodulation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases