Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease

NCT04010084 | Unknown DMC

• 1 other identifier: OliverDPOC
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Photobiomodulation

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (3)

• TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α

  4 weeks

• Spirometry

  4 weeks

• Quality of life assessment questionnaire

  4 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

Procedure: Placebo group

Laser group

ACTIVE COMPARATOR

Radiation: Low level laser therapy

Interventions

Low level laser therapy RADIATION

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.

Laser group

Placebo group PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant will be randomized through a raffle without knowing which group has the active intervention or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: July 8, 2019
• Study Start: August 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 3, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07