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Search / Trial NCT06773676

Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis

Launched by BARZILAI MEDICAL CENTER · Jan 13, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Osteoarthritis Knee Osteoarthritis

ClinConnect Summary

This clinical trial is exploring whether a home laser device, called the B-Cure Laser, can help reduce pain and improve movement for people with knee osteoarthritis (KOA). Osteoarthritis is a condition that causes the cartilage in the joints to wear down, leading to pain and difficulty moving. The trial aims to see if using this laser device at home, with the help of a caregiver if needed, can make a difference in managing the symptoms of KOA.

To participate in the study, you need to be diagnosed with knee osteoarthritis and have specific levels of knee pain when you move. The trial is open to adults aged 18 and older. However, there are some exclusions, such as being pregnant, having other serious health conditions, or having had recent knee surgery. If you join the trial, you will use the laser device at home and report on your pain and movement over time. This is an exciting opportunity to explore a new way to manage knee pain that could improve your quality of life.

Gender

ALL

Eligibility 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.

About Barzilai Medical Center

Barzilai Medical Center is a leading healthcare institution located in Ashkelon, Israel, renowned for its commitment to advancing medical research and patient care. As a prominent clinical trial sponsor, Barzilai Medical Center focuses on innovative treatments and therapies across various medical disciplines, collaborating with a multidisciplinary team of healthcare professionals and researchers. The center is dedicated to maintaining the highest standards of ethical practices and regulatory compliance, ensuring the safety and well-being of participants while contributing to the global body of medical knowledge. Through its robust clinical trial infrastructure, Barzilai Medical Center aims to facilitate groundbreaking research that enhances patient outcomes and fosters the development of new therapeutic options.

Locations

Ashkelon, Southern Region, Israel

Patients applied

0 patients applied

Trial Officials

Omri Lubovsky, MD

Principal Investigator

Barzilai University Medical Center Ashkelon Israel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported