Actively Recruiting
Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for Treatment of Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Sham-Controlled Clinical Study
Led by Barzilai Medical Center · Updated on 2025-01-14
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of a near-infrared photobiomodulation (PBM) device called B-Cure Laser to treat knee osteoarthritis (KOA), a common degenerative joint disease that causes pain and disability in older adults. This clinical trial aims to find out if using this home device can reduce pain and improve knee function for people with KOA. The study is designed as a prospective, double-blind, randomized, sham-controlled trial to compare the active device with a sham version. Participants will be randomly assigned to one of two groups: one group will receive standard care plus self-treatment at home with the active B-Cure laser device, while the other group will receive standard care plus a sham device that looks similar but does not emit therapeutic infrared light. The device emits near-infrared light at 808 nm with a power output of 250 mW and an energy dose of 1 J/cm², applied over a small area. Treatments will be performed at home by the patient or caregiver over a three-month period. Participants will visit the clinic three times: at the start, after one month, and after three months. During these visits, they will undergo physical exams, range of motion assessments, and complete questionnaires about pain levels using a visual analog scale (VAS), knee function via the WOMAC index, and quality of life using the SF-12. They will also keep a diary of their treatments and any use of pain-relief medications. The primary outcome is the change in pain level after one month of treatment. Safety and effectiveness will be monitored throughout the study, which is expected to end in early 2027.
CONDITIONS
Brief 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 between 40 and 90 mm on the Visual Analog Scale
- Knee pain and related functional reduction lasting at least 1 month
- Age between 50 and 90 years
You will not qualify if you...
- Pregnant, nursing, or able to become pregnant without using accepted birth control
- Other causes of knee pain ruled out (e.g., hip osteoarthritis, arterial insufficiency, radiculopathy)
- Previous knee surgery for osteoarthritis
- Intra-articular steroid injection or oral steroid treatment within the last 6 months
- Rheumatoid arthritis
- Symptomatic osteoarthritis in other joints (hip, hand)
- Use of narcotics on the day of evaluation
- Active cancer
- Uncontrolled diabetes mellitus
- Neurological conditions such as sciatica, neuropathy, or multiple sclerosis
- Other chronic pain conditions like fibromyalgia, back pain, or hip pain
- Previous or current use of photobiomodulation devices for knee pain
- Known skin sensitivity to light
- Participation in another clinical trial within the last 6 weeks or during this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants self-treat at home with either the active B-Cure laser device or a sham device in addition to standard care.
3 visits (baseline, 1 month, and 3 months, in-person)
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
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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