What this Trial Is About

Knee osteoarthritis is a common degenerative joint disease that causes pain and reduced function, especially in older adults. Researchers are evaluating a home-use near-infrared photobiomodulation device called the B-Cure Laser to see if it can reduce pain and improve function in patients with knee osteoarthritis. This study is a double-blind, randomized, sham-controlled clinical trial designed to compare the effects of active laser treatment versus a sham device alongside standard care. Participants will receive either the active B-Cure laser pro device or a sham device that looks and sounds the same but does not emit therapeutic rays. They will use these devices at home for self-treatment. The B-Cure laser pro emits near-infrared light at 808 nm with a power output of 250mW and an energy dose of 1J/cm2 over a small treatment area. The study includes three clinic visits at baseline, 1 month, and 3 months, during which physical exams, joint range of motion, and patient-reported outcomes will be collected. During the study, participants will report their pain levels using a visual analogue scale (VAS), complete questionnaires on arthritis symptoms and quality of life, and keep a diary documenting treatments and pain medication use. The main outcome measured is the change in pain level from baseline after 1 month. This trial aims to understand if home use of the photobiomodulation device can safely reduce knee osteoarthritis pain and improve daily function over standard care alone.

Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis