NCT05357703

Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis

Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: An Open Label, Single-Arm Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Erika Carmel ltd · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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 B-Cure laser treatments, applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.

Detailed description

Eligible patients with knee osteoarthritis will receive a B-Cure laser device for self-application at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1, and 2 months. Evaluations at the visits will include physical examination, knee range of motion, time up\&go test, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), functional and quality of life questionnaires. The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can ameliorate KOA related inflammation thereby reducing pain and improving functionality in these patients.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Standard treatment + Active B-Cure laser	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 5J/minute.

Timeline

• Start date: 2022-05-26
• Primary completion: 2023-05-15
• Completion: 2023-08-15
• First posted: 2022-05-03
• Last updated: 2022-06-01

Locations

1 site across 1 country: Israel