Using a home laser device to treat knee osteoarthritis
Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Sham-Controlled Clinical Study
This study is testing if using a home laser device can help people with knee osteoarthritis feel less pain and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Barzilai Medical Center Academic / other |
| Locations | 1 site (Ashkelon, Southern District) |
| Trial ID | NCT06773676 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with knee osteoarthritis who experience moderate pain and functional limitations.
Not a fit: Patients with other causes of knee pain, recent knee surgery, or certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive, at-home option for managing pain and improving function in patients with knee osteoarthritis.
How similar studies have performed: Other studies have shown promise with photobiomodulation for pain relief, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ashkelon, Southern District
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.