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OpenTrials
Completed

NCT Number: NCT05041231

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Both Hands Osteoarthritis Finger Osteoarthritis Hand Rheumatic Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Vita

São Paulo, 05653-070, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation therapy (PBT)

Device

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

Sham Photobiomodulation therapy (Sham PBT)

Device

Similar to active PBT, however, the device will not provide the active electromagnetic waves)

Other names: Sham Laser

Primary outcomes

  1. Change from Baseline Pain at

    Time frame: 4 weeks and 2 months

    Visual analogue scale for pain

  2. Change from Baseline Arm, Shoulder and Hand Disability

    Time frame: 4 weeks and 2 months

    The Disabilities of the Arm, Shoulder and Hand Score

Secondary outcomes

  1. Change from Baseline Hand grip

    Time frame: 4 weeks and 2 months

    Hand grip strenght measured by Digital Hand Dynamometer

  2. Change from Baseline Pinch force

    Time frame: 4 weeks and 2 months

    Pulp to pulp (pinch) force

  3. Willingness to recommend the treatment

    Time frame: 4 weeks and 2 months

    Net Promoter Score

  4. Change from Baseline Hand Disability

    Time frame: 4 weeks and 2 months

    Brief Michigan questionnaire

Sponsors and collaborators

Lead sponsor

Vita Care

Other

Collaborators

  • Tegos S.A.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 10, 2021
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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