Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
Key facts
- Who runs it
- Barzilai Medical Center
- Where
- Israel1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 14 Jan 2025
- Expected to end
- 31 Jan 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- B-Cure laser pro
- Sham
- Record updated
- 14 January 2025
Who can take part
- Age
- 50 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Knee surgery for KOA
- Intra-articular steroid injection and/or oral steroid treatment within the last six months
- Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations
- Active malignancy
- Uncontrolled diabetes mellitus
- Neurological conditions: sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Rheumatoid arthritis
- Symptomatic OA in other joints (i.e. hip, hand)
- Use of narcotics on the day of evaluation
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 90 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Standard + B-Cure ProExisting treatment, for comparison
Subjects from the Standard + B-Cure Pro group will receive standard care and in addition will self-treat at home with the B-Cure device
Treatment: B-Cure laser pro
- Standard + ShamSham treatment, for comparison
Subjects from the Standard + Sham group will receive standard care and in addition will self-treat at home with the sham B-Cure device
Treatment: Sham
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Sham-Controlled Clinical Study
- Fit questions
- Built from NCT06773676, who can take part
- Record updated
- 14 January 2025