Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
Recruiting · NCT06773676 · Interventional (participants receive a specific treatment) · Lead sponsor: Barzilai Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
B-Cure laser proSham
What this trial is about
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.
Who can take part
Age range
50 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- Rheumatoid arthritis
- Symptomatic OA in other joints (i.e. hip, hand)
- Use of narcotics on the day of evaluation
- Active malignancy
- Uncontrolled diabetes mellitus
- Neurological conditions: sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
- Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
- Has known dermatological sensitivity to light
- Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
Where it is running
1 location listed.
- Barzilai University Medical Center - Ashkelon, Southern District, Israel