Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis

Launched by ERIKA CARMEL LTD · Apr 27, 2022

Keywords

ClinConnect Summary

Eligible patients with knee osteoarthritis will receive a B-Cure laser device for self-application at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1, and 2 months. Evaluations at the visits will include physical examination, knee range of motion, time up\&go test, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), functional and quality of life questionnaires.

The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can ameliorate KOA related inflammation thereby r...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
• • 2. Kellgren \& Lawrence classification 2-3
• • 3. Knee pain on movement 40 to 90 mm Visual Analog Scale
• • 4. Knee pain and related functional reduction for the last ≥ 3 months
• • 5. Agrees not to use NSAIDs throughout the experiment
• 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. Active malignancy
• • 7. Uncontrolled diabetes mellitus
• • 8. Neurological conditions: sciatica, neuropathy, multiple sclerosis
• • 9. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
• • 10. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
• • 11. Has known dermatological sensitivity to light
• • 12. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
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