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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Study of the Effects of Photobiomodulation in Patients With Osteoarthritis

Clinicaltrials.gov identifier NCT03924128

Recruitment Status Available

First Posted April 23, 2019

Last update posted March 27, 2020

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:Osteo Arthritis Knee
    Pain, Chronic
    Inflammation
  • Intervention/Treatment: Device: Photobiomodulation
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Expanded Access
  • Official Title: Study of the Effects of Photobiomodulation in Patients With Osteoarthritis
  • Study Start Date: N/A
  • Primary Completion Date: N/A
  • Study Completion Date: N/A
Outcome Measures
Eligibility Criteria
  • Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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
Contacts

Contact: Marucia Chacur, PhD +551130918452 chacurm@icb.usp.br

Contact: Hazel Abel Ashmawi, M.D. hazem.ashmawi@hc.fm.usp.br

Locations

Brazil, SP
University of Sao Paulo
São Paulo

Sponsors and Collaborators

University of Sao Paulo

Investigators

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

More Information
  • Responsible Party: University of Sao Paulo
  • ClinicalTrials.gov Identifier: NCT03924128 History of Changes
  • Other Study ID Numbers: 93744418.5.0000.0068
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: March 27, 2020
  • Last Verified: March 2020
  • Additional relevant MeSH terms: Osteoarthritis
    Osteoarthritis, Knee
    Inflammation
    Chronic Pain