Study of the Effects of Photobiomodulation in Patients With Osteoarthritis

NCT03924128 | Unknown

• 1 other identifier: 93744418.5.0000.0068
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

PhotoBioModulation (PBM) is a mature science with therapeutic efficacy in humans and animals, and with excellent results in different medical specialties without side effects. However there are gaps that prevent adoption on a large scale. Recent research developed by our group and partners allowed us to understand the mechanisms of action of PBM, from Molecular Physics through Biochemistry and with consequent clinical validation, with precise, replicable and personalized therapeutic results. These findings have led to treatments for many kinds of pains with industrial predictability and accuracy, phenotypic adequacy technologies that are encapsulated, prescribed, and applied. Photobiomodulation applications cover treatments for pain, inflammation, tissue regeneration, healing, immune system activation, all of which are essential characteristics for osteoarthritis therapy. Our idea is to formulate great challenges of Photobiomodulation as a solution to osteoarthritis as follows: 1) Make PBM-based therapies as predictable as drug-based therapies; this is possible with precise dose calculation performed by our team; 2) Map the biochemical and molecular effects of PBM, including those related to gene expression; 3) Unify PBM theory by synthesizing and giving meaning to the millions of PBM data associated with osteoarthritis and correlating with clinical study to be performed under this thematic project. Overcoming these challenges, PBM will become a complementary (or supplementary) alternative to medications, physiotherapy and surgical procedures for the treatment of osteoarthritis.

Conditions

Osteo Arthritis Knee; Pain, Chronic; Inflammation

Interventions

Photobiomodulation DEVICE

The Photobiomodulation device should cover the entire knee junction, with time of application from 6 to 8 minutes and device turned on.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects age ≥ 20 years old
• Diagnosed with Osteoarthritis stages III and IV according to the American College of Rheumatology
• Pain
• Functional impairment for more than 3 months, able to wander with or without canes.

You may not qualify if:

• History of cancer
• Unstable cardiovascular disease
• uncontrolled hypertension
• morbid obesity, that is, BMI ≥ 40
• terminal illness
• cerebrovascular disease
• dementia
• heart pacemaker
• superior or inferior limb fractures.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Chronic Pain; Inflammation

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Nathalia Lopes Ferreira, graduate

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 23, 2019
• Last Updated: November 4, 2022

Record last verified: 2022-10

Locations

BR (1)