Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT05357703
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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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT05357703
Study Brief:
Protocol Section:
NCT05357703