An interventional study of Photobiomodulation therapy (PBT) and Sham Photobiomodulation therapy (Sham PBT) in Osteoarthritis, Osteoarthritis Finger and Osteoarthritis Hand, sponsored by Vita Care. Completed at 1 site in Brazil. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by Vita Care · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 46 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Vita Care is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment procedure performed with the device that will not provide the bioactive light (laser)
Device: Sham Photobiomodulation therapy (Sham PBT)
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).
Also known as: Laser
Similar to active PBT, however, the device will not provide the active electromagnetic waves)
Also known as: Sham Laser
Change from Baseline Pain at
Visual analogue scale for pain
Time frame: 4 weeks and 2 months
Change from Baseline Arm, Shoulder and Hand Disability
The Disabilities of the Arm, Shoulder and Hand Score
Time frame: 4 weeks and 2 months
Change from Baseline Hand grip
Hand grip strenght measured by Digital Hand Dynamometer
Time frame: 4 weeks and 2 months
Change from Baseline Pinch force
Pulp to pulp (pinch) force
Time frame: 4 weeks and 2 months
Willingness to recommend the treatment
Net Promoter Score
Time frame: 4 weeks and 2 months
Change from Baseline Hand Disability
Brief Michigan questionnaire
Time frame: 4 weeks and 2 months
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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