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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Osteoarthritis Finger, Osteoarthritis Hand, Osteoarthritis Both Hands

Intervention / Treatment
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* Device: Photobiomodulation therapy (PBT)
* Device: Sham Photobiomodulation therapy (Sham PBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham (group A)<br>Treatment procedure performed with the device that will not provide the bioactive light (laser) | Device: Sham Photobiomodulation therapy (Sham PBT)<br>* Similar to active PBT, however, the device will not provide the active electromagnetic waves)<br>* Other names: Sham Laser;|
| Experimental: PBT (group B)<br>Treatment procedure performed with the device that will provide the bioactive light (laser) | Device: Photobiomodulation therapy (PBT)<br>* 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).<br>* Other names: Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |