Actively Recruiting
Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
Led by Barzilai Medical Center · Updated on 2025-01-14
50
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with knee osteoarthritis by American College of Rheumatology criteria
- Kellgren & Lawrence classification between 1 and 3
- Knee pain on movement rated 40 to 90 mm on Visual Analog Scale
- Knee pain and related functional decline lasting at least 1 month
You will not qualify if you...
- Pregnant, nursing, or able to become pregnant without birth control
- Other causes of knee pain ruled out (e.g., hip osteoarthritis, arterial insufficiency, radiculopathy)
- Previous knee surgery for osteoarthritis
- Steroid injections or oral steroid treatment within past 6 months
- Rheumatoid arthritis
- Symptomatic osteoarthritis in other joints (hip, hand)
- Use of narcotics on evaluation day
- Active cancer
- Uncontrolled diabetes mellitus
- Neurological conditions such as sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions affecting results (fibromyalgia, back pain, hip pain)
- Previous use of photobiomodulation devices for knee pain
- Known skin sensitivity to light
- Participation in another clinical trial within past 6 weeks or during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Barzilai University Medical Center
Ashkelon, Southern District, Israel, 7830604
Actively Recruiting
Research Team
G
Galia Cohen Peres, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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