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| Name | Class |
|---|---|
| Tegos S.A. | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham (group A) | Sham Comparator | Treatment procedure performed with the device that will not provide the bioactive light (laser) |
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| PBT (group B) | Experimental | Treatment procedure performed with the device that will provide the bioactive light (laser) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Pain at | Visual analogue scale for pain | 4 weeks and 2 months |
| Change from Baseline Arm, Shoulder and Hand Disability | The Disabilities of the Arm, Shoulder and Hand Score | 4 weeks and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Hand grip | Hand grip strenght measured by Digital Hand Dynamometer | 4 weeks and 2 months |
| Change from Baseline Pinch force | Pulp to pulp (pinch) force |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mateus Saito, PhD | Medical Director Instituto Vita | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Vita | São Paulo | São Paulo | 05653-070 | Brazil |
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|
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| Sham Photobiomodulation therapy (Sham PBT) | Device | Similar to active PBT, however, the device will not provide the active electromagnetic waves) |
|
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| 4 weeks and 2 months |
| Willingness to recommend the treatment | Net Promoter Score | 4 weeks and 2 months |
| Change from Baseline Hand Disability | Brief Michigan questionnaire | 4 weeks and 2 months |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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