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

NCT ID: NCT05357703

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2023-08-15

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment + Active B-Cure laser

Subjects from Standard treatment + Active B-Cure laser will receive standard care and in addition will self-treat at home with the B-Cure device.

Group Type: EXPERIMENTAL

Standard treatment + Active B-Cure laser

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 5J/minute.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)

2. Kellgren & Lawrence classification 2-3

3. Knee pain on movement 40 to 90 mm Visual Analog Scale

4. Knee pain and related functional reduction for the last ≥ 3 months

5. Agrees not to use NSAIDs throughout the experiment

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. Active malignancy

7. Uncontrolled diabetes mellitus

8. Neurological conditions: sciatica, neuropathy, multiple sclerosis

9. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain

10. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain

11. Has known dermatological sensitivity to light

12. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.

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

Sponsors

Holy Family Hospital, Nazareth, Israel

OTHER

Sponsor Role: collaborator

Erika Carmel ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marwan Hadad, MD

Role: PRINCIPAL_INVESTIGATOR

The Holy Family Hospital, Nazareth, Israel

Locations

Holy Family Hospital

Nazareth, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Jehad Khazen, MD

Role: CONTACT

khazenjehad@gmail.com

+972545600095

Facility Contacts

Jehad Khazen, MD

Role: primary

khazenjehad@gmail.com

972545600095

Maroun Yacoub

Role: backup

maroun@gd-energies.com

+9720543349738 ext. +9720543349738

Other Identifiers

HFH-256-2022

Identifier Type: -

Identifier Source: org_study_id