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Recruiting NCT06773676

NCT06773676 Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis

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Clinical Trial Summary
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

Condition Osteoarthritis Of Knee
Sponsor Barzilai Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 50 Years
Max Age 90 Years
Start Date 2025-01-14
Completion 2026-01-31
Interventions
B-Cure laser proSham

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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

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