Clincosm LogoSign in Get a demo

Study of the Effects of Photobiomodulation in Patients With Osteoarthritis

Sponsor
University of Sao Paulo (Other)
Overall Status
Available
CT.gov ID
NCT03924128
Collaborator
(none)
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Photobiomodulation

Study Design

Study Type:
Expanded Access
Official Title:
Study of the Effects of Photobiomodulation in Patients With Osteoarthritis

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Sao Paulo São Paulo SP Brazil 05508-000

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Principal Investigator: Nathalia Lopes Ferreira, Undergraduate, University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    marucia chacur, PhD, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT03924128
    Other Study ID Numbers:
    • 93744418.5.0000.0068
    First Posted:
    Apr 23, 2019
    Last Update Posted:
    Mar 27, 2020
    Last Verified:
    Mar 1, 2020
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Inflammation
    Chronic Pain

    Study Results

    No Results Posted as of Mar 27, 2020