Osteoarthritis, Osteoarthritis Both Hands, Osteoarthritis Finger, Osteoarthritis Hand
Conditions
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.
Interventions
DEVICEPhotobiomodulation 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).
DEVICESham Photobiomodulation therapy (Sham PBT)
Similar to active PBT, however, the device will not provide the active electromagnetic waves)
Sponsors
Tegos S.A.
Vita Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Pain at | 4 weeks and 2 months | Visual analogue scale for pain |
| Change from Baseline Arm, Shoulder and Hand Disability | 4 weeks and 2 months | The Disabilities of the Arm, Shoulder and Hand Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Hand grip | 4 weeks and 2 months | Hand grip strenght measured by Digital Hand Dynamometer |
| Change from Baseline Pinch force | 4 weeks and 2 months | Pulp to pulp (pinch) force |
| Willingness to recommend the treatment | 4 weeks and 2 months | Net Promoter Score |
| Change from Baseline Hand Disability | 4 weeks and 2 months | Brief Michigan questionnaire |
Countries
Brazil
Outcome results
None listed