Status:
UNKNOWN
Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
Osteoarthritis (OA) is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. The treatment of this disease remains limited ...
Eligibility Criteria
Inclusion
- Diagnoses of knee osteoarthritis:( American College of Rheumatology (ACR) criteria (see below) - possibilities:ACR1: Fulfilled at least one of the classification criteria of the American College of Rheumatology ACR2: KOA verified with the American College of Rheumatology criteria using a history and physical examination, i.e. knee pain and at least three of the following: 50-85 years old, ≤ 30 minutes of morning stiffness, crepitus on active range of motion, bony tenderness, bony enlargement, and no palpable warmth of synovia Radiographic evidence of knee osteoarthritis between 2-3 in Kellgren and Lawrence classification
- KOA grade 2-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain for the last ≥ 3 months
- Functional reduction in the last three months
- Agrees not to use NSAIDs throughout the experiment
- Agrees not to use any other treatment (except rescue drugs) for KOA during participation in this study.
Exclusion
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, 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;
- Symptomatic OA in other joints (i.e. hip, hand)
- Use of analgesics on the day of evaluation
- Use of NSAIDs 2 weeks before the beginning of the treatment
- Active malignancy
- Uncontrolled diabetes mellitus
- Neurological conditions: sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions: Fibromyalgia, back pain, hip pain
- Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04276038
Start Date
March 1 2020
End Date
March 1 2022
Last Update
February 21 2020
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