Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis (PBM&KOA-02)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Standard treatment + Active B-Cure laser

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jehad Khazen, MD; Phone Number: +972545600095; Email: khazenjehad@gmail.com

Study Locations

• Israel
  • Nazareth, Israel
    • Recruiting
    • Holy Family Hospital
    • Contact: Jehad Khazen, MD; Phone Number: 972545600095; Email: khazenjehad@gmail.com
    • Contact: Maroun Yacoub; Phone Number: +9720543349738 +9720543349738; Email: maroun@gd-energies.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of pain	Change from baseline in pain score by VAS	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in WOMAC score [ time point - 1 month]	The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness. It widely used in clinical studies as primary or secondary outcome.	one month

Collaborators and Investigators

• Sponsor: Erika Carmel ltd
• Collaborators: Holy Family Hospital, Nazareth, Israel
• Investigators: Principal Investigator: Marwan Hadad, MD, The Holy Family Hospital, Nazareth, Israel

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 26, 2022
• Primary Completion (ANTICIPATED): May 15, 2023
• Study Completion (ANTICIPATED): August 15, 2023

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (ACTUAL): May 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Photobiomodulation; Low-Level Laser Therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HFH-256-2022

Drug and device information, study documents

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