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Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis

Sponsor
Vita Care (Other)
Overall Status
Recruiting
CT.gov ID
NCT05041231
Collaborator
Tegos S.A. (Other)
56
Enrollment
1
Location
2
Arms
10.2
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and functional limitation. In the hand, more specifically in the proximal and distal interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of the disease. Numerous treatments, whether drug, rehabilitation or surgery, have been proposed with the aim of both interrupting the natural evolution of the disease and alleviating or stopping the symptoms. This study aims to evaluate the effectiveness of personalized Photobiomodulation Therapy (PBT) with regard to alleviating symptoms and improving the quality of life of these patients with the disease.

Condition or Disease Intervention/Treatment Phase
  • Device: Photobiomodulation therapy (PBT)
  • Device: Sham Photobiomodulation therapy (Sham PBT)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis
Actual Study Start Date :
Aug 25, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham (group A)

Treatment procedure performed with the device that will not provide the bioactive light (laser)

Device: Sham Photobiomodulation therapy (Sham PBT)
Similar to active PBT, however, the device will not provide the active electromagnetic waves)
Other Names:
  • Sham Laser

    		•
    Experimental: PBT (group B)

    Treatment procedure performed with the device that will provide the bioactive light (laser)

    Device: Photobiomodulation therapy (PBT)
    Any invasive procedures will be done. The treatment in question will be done by a device that looks like a bracelet, which is placed on the hand/fingers to emit light/laser and does not cause pain or temperature change. There will be 8 photobiomodulation sessions, 2 per week, 10 minutes each session. The dosimetric parameters of the therapy will be carried out in a standardized and personalized way, with programming of the light and all the necessary information so that the device can carry out the application of the treatment application of electromagnetic waves in the red and infrared spectral range 660-1000 nm).
    Other Names:
  • Laser

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Pain at [4 weeks and 2 months]

      Visual analogue scale for pain

    2. Change from Baseline Arm, Shoulder and Hand Disability [4 weeks and 2 months]

      The Disabilities of the Arm, Shoulder and Hand Score

    Secondary Outcome Measures

    1. Change from Baseline Hand grip [4 weeks and 2 months]

      Hand grip strenght measured by Digital Hand Dynamometer

    2. Change from Baseline Pinch force [4 weeks and 2 months]

      Pulp to pulp (pinch) force

    3. Willingness to recommend the treatment [4 weeks and 2 months]

      Net Promoter Score

    4. Change from Baseline Hand Disability [4 weeks and 2 months]

      Brief Michigan questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical and radiological diagnosis of OA of the fingers of the hand and Rizarthrosis

    • Patients with pain for at least 3 months

    • Patients undergoing treatment and rehabilitation for finger OA and rhizarthrosis

    • Patient with good understanding of the Portuguese language who agrees to participate and sign the ICF

    Exclusion Criteria:

    • Posttraumatic arthritic changes

    • Systemic inflammatory arthritis (Rheumatoid Arthritis, Lupus Erythematosus, Psoriasis…)

    • Patients with local or systemic, acute or chronic infections

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Vita São Paulo SP Brazil 05653-070

    Sponsors and Collaborators

    • Vita Care
    • Tegos S.A.

    Investigators

    • Principal Investigator: Mateus Saito, PhD, Medical Director Instituto Vita

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vita Care
    ClinicalTrials.gov Identifier:
    NCT05041231
    Other Study ID Numbers:
    • 133
    First Posted:
    Sep 10, 2021
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of Apr 28, 2022