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

NCT05357703 | Unknown DMC

• 1 other identifier: HFH-256-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Photobiomodulation; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• level of pain

  Change from baseline in pain score by VAS

  one month

Secondary Outcomes (1)

• Change from baseline in WOMAC score [ time point - 1 month]

  one month

Study Arms (1)

Standard treatment + Active B-Cure laser

EXPERIMENTAL

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

Interventions

Standard treatment + Active B-Cure laser 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.

Standard treatment + Active B-Cure laser

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
• Kellgren \& Lawrence classification 2-3
• Knee pain on movement 40 to 90 mm Visual Analog Scale
• Knee pain and related functional reduction for the last ≥ 3 months
• Agrees not to use NSAIDs throughout the experiment

You may not qualify if:

• Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
• Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
• Knee surgery for KOA
• Intra-articular steroid injection and/or oral steroid treatment within the last six months
• Rheumatoid arthritis
• Active malignancy
• Uncontrolled diabetes mellitus
• Neurological conditions: sciatica, neuropathy, multiple sclerosis
• Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
• Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
• Has known dermatological sensitivity to light
• Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.

Sponsors & Collaborators

• Erika Carmel ltd: lead
• Holy Family Hospital, Nazareth, Israel: collaborator

Study Sites (1)

Holy Family Hospital

Nazareth, Israel

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marwan Hadad, MD

  The Holy Family Hospital, Nazareth, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jehad Khazen, MD

CONTACT

+972545600095; khazenjehad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: May 26, 2022
• Primary Completion: May 15, 2023
• Study Completion: August 15, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-04

Locations

IL (1)