Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
NCT06773676 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-01-14
Summary
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
- Osteoarthritis Of Knee
Interventions
- DEVICE
-
B-Cure laser pro
The 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.
- DEVICE
-
Sham
The sham device is externally identical to active, emits the same guiding light and sound but does not emit the therapeutic near infrared invisible rays
Sponsors & Collaborators
-
Barzilai Medical Center
lead OTHER
Principal Investigators
-
Omri Lubovsky, MD · Barzilai University Medical Center Ashkelon Israel
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-14
- Primary Completion
- 2026-01-31
- Completion
- 2027-01-31
Countries
- Israel
Study Locations
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