Status:
UNKNOWN
Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis
Lead Sponsor:
Erika Carmel ltd
Collaborating Sponsors:
Holy Family Hospital, Nazareth, Israel
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-90 years
Phase:
NA
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 ...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
- Kellgren \& Lawrence classification 2-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain and related functional reduction for the last ≥ 3 months
- Agrees not to use NSAIDs throughout the experiment
Exclusion
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
- Knee surgery for KOA
- Intra-articular steroid injection and/or oral steroid treatment within the last six months
- Rheumatoid arthritis
- Active malignancy
- Uncontrolled diabetes mellitus
- Neurological conditions: sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
- Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
- 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.
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Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05357703
Start Date
May 26 2022
End Date
August 15 2023
Last Update
June 1 2022
Active Locations (1)
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1
Holy Family Hospital
Nazareth, Israel