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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis Of Knee
• Intervention / Treatment: Device: B-Cure laser pro; Device: Sham

Detailed Description

This is a prospective double blind randomized sham-controlled clinical trial. Eligible participants with KOA will be randomly allocated to receive active or sham devices for self-treatment at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1 month, and 3 months. Evaluations will include physical examination, range of motion, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quality of life questionnaire (SF-12). Participants will document treatments and analgesic-drug use in a diary.

The study hypothesis is that B-Cure laser treatments, applied at home by the patient, can reduce pain and improve functionality compared to standard care alone.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Galia Cohen Peres, BA; Phone Number: +972-54-2211779; Email: cohenperesg@bmc.gov.il

Study Locations

• Israel
  • Southern Region
    • Ashkelon, Southern Region, Israel, 7830604
      • Recruiting
      • Barzilai University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard + B-Cure Pro; Subjects from the Standard + B-Cure Pro group will receive standard care and in addition will self-treat at home with the B-Cure device	Device: B-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.
Sham Comparator: Standard + Sham; Subjects from the Standard + Sham group will receive standard care and in addition will self-treat at home with the sham B-Cure device	Device: Sham; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in level of pain by VAS	Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain".	1month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in WOMAC score	The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-administered questionnaire used to assess the severity of symptoms and functional limitations in individuals with hip or knee osteoarthritis (OA). It consists of 24 items, each scored on a scale of 0-4. Higher scores indicate worse pain, stiffness, and functional limitations.	1 month

Collaborators and Investigators

• Sponsor: Barzilai Medical Center
• Investigators: Principal Investigator: Omri Lubovsky, MD, Barzilai University Medical Center Ashkelon Israel

Study record dates

Study Major Dates

• Study Start (Estimated): January 14, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee Osteoarthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 0019-22-BRZ; MOH_2024-12-09_013784 (Registry Identifier: Israel Ministary of Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No