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

NCT ID: NCT06773676

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2027-01-31

Brief 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.

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.

Conditions

Osteoarthritis Of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

B-Cure laser pro

Intervention Type: DEVICE

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.

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

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barzilai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Omri Lubovsky

Head of Orthopedic Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omri Lubovsky, MD

Role: PRINCIPAL_INVESTIGATOR

Barzilai University Medical Center Ashkelon Israel

Locations

Barzilai University Medical Center

Ashkelon, Southern District, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Galia Cohen Peres, BA

Role: CONTACT

cohenperesg@bmc.gov.il

+972-54-2211779

Other Identifiers

MOH_2024-12-09_013784

Identifier Type: REGISTRY

Identifier Source: secondary_id

0019-22-BRZ

Identifier Type: -

Identifier Source: org_study_id