NCT06773676 Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
| NCT ID | NCT06773676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barzilai Medical Center |
| Condition | Osteoarthritis Of Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-14 |
| Primary Completion | 2026-01-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR) 2. Kellgren \& Lawrence classification 1-3 3. Knee pain on movement 40 to 90 mm Visual Analog Scale 4. Knee pain and related functional reduction for at least 1 month Exclusion Criteria: 1. Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control 2. Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations. 3. Knee surgery for KOA 4. Intra-articular steroid injection and/or oral steroid treatment within the last six months 5. Rheumatoid arthritis 6. Symptomatic OA in other joints (i.e. hip, hand) 7. Use of narcotics on the day of evaluation 8. Active malignancy 9. Uncontrolled diabetes mellitus 10. Neurological conditions: sciatica, neuropathy, multiple sclerosis 11. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain 12. Has