RecruitingNot ApplicableNCT06773676

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


Sponsor

Barzilai Medical Center

Enrollment

50 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if a near-infrared PBM device (B-Cure Laser), applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.


Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This double-blind randomized trial is testing whether a home-use near-infrared laser device (B-Cure Laser) — a type of photobiomodulation (light therapy) — can reduce pain and improve function in patients with knee osteoarthritis when used alongside standard care. Photobiomodulation has shown promise in easing inflammation and pain in knee osteoarthritis, and this study asks whether patients can effectively self-administer it at home. Adults with a confirmed knee osteoarthritis diagnosis, Kellgren-Lawrence grade 1–3, moderate-to-severe knee pain (40–90mm on a visual scale) for at least one month are eligible, while those with previous knee surgery, rheumatoid arthritis, neurological pain conditions, or active cancer are excluded. Participants will use either an active or a sham device at home and attend three clinic visits over three months for physical assessments and questionnaires about pain, function, and quality of life. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEB-Cure laser pro

The B-Cure laser pro is a portal, non-invasive, photobiomodulation device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 1J/cm2.

DEVICESham

The sham device is externally identical to active, emits the same guiding light and sound but does not emit the therapeutic near infrared invisible rays


Locations(1)

Barzilai University Medical Center

Ashkelon, Southern District, Israel

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NCT06773676


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