Using a home laser device to treat knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a near-infrared photobiomodulation (PBM) device, the B-Cure Laser, for treating knee osteoarthritis (KOA) in a home setting. Participants will be randomly assigned to receive either the active laser device or a sham device, in addition to standard care. The study will involve three clinic visits to assess pain levels, functionality, and quality of life through various questionnaires and physical examinations. The goal is to determine if self-administered laser treatments can significantly reduce pain and improve mobility in patients with KOA.

Why it matters

Who can join: the full rules

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 any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
13. Has known dermatological sensitivity to light
14. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.

Where it's running

• Barzilai University Medical Center
  Ashkelon, Southern District, Israel Recruiting

Study contacts

• Principal investigator: Omri Lubovsky, MD — Barzilai University Medical Center Ashkelon Israel
• Study coordinator: Galia Cohen Peres, BA
• Email: cohenperesg@bmc.gov.il
• Phone: +972-54-2211779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.