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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041231
• Other study ID #: 133
• Status: Completed
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: January 2023
• Source: Vita Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 20, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Both Hands
• Osteoarthritis Finger
• Osteoarthritis Hand

Intervention

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).
• Sham Photobiomodulation therapy (Sham PBT)
Similar to active PBT, however, the device will not provide the active electromagnetic waves)

Locations

Country	Name	City	State
Brazil	Instituto Vita	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Vita Care	Tegos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Pain at	Visual analogue scale for pain	4 weeks and 2 months
Primary	Change from Baseline Arm, Shoulder and Hand Disability	The Disabilities of the Arm, Shoulder and Hand Score	4 weeks and 2 months
Secondary	Change from Baseline Hand grip	Hand grip strenght measured by Digital Hand Dynamometer	4 weeks and 2 months
Secondary	Change from Baseline Pinch force	Pulp to pulp (pinch) force	4 weeks and 2 months
Secondary	Willingness to recommend the treatment	Net Promoter Score	4 weeks and 2 months
Secondary	Change from Baseline Hand Disability	Brief Michigan questionnaire	4 weeks and 2 months