Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if a near-infrared PBM device (B-Cure Laser), applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.
Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
Kellgren & Lawrence classification 1-3
Knee pain on movement 40 to 90 mm Visual Analog Scale
Knee pain and related functional reduction for at least 1 month
Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
Knee surgery for KOA
Intra-articular steroid injection and/or oral steroid treatment within the last six months
Parallel
B-Cure laser pro
DeviceThe B-Cure laser pro is a portal, non-invasive, photobiomodulation device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 1J/cm2.
Sham
DeviceThe sham device is externally identical to active, emits the same guiding light and sound but does not emit the therapeutic near infrared invisible rays
Change from baseline in level of pain by VAS
Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain".
Change from baseline in WOMAC score
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-administered questionnaire used to assess the severity of symptoms and functional limitations in individuals with hip or knee osteoarthritis (OA). It consists of 24 items, each scored on a scale of 0-4. Higher scores indicate worse pain, stiffness, and functional limitations.
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