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

NCT06773676 | Recruiting

• 2 other identifiers: 0019-22-BRZMOH_2024-12-09_013784
• Study Type: interventional
• Target: 50
• 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 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.

Conditions

Osteoarthritis Of Knee

Keywords

Osteoarthritis; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in WOMAC score

  1 month

Study Arms (2)

Standard + B-Cure Pro

ACTIVE COMPARATOR

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

Standard + Sham

SHAM COMPARATOR

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

Interventions

B-Cure laser pro 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 + B-Cure Pro

Sham 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

Standard + Sham

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 1-3
• Knee pain on movement 40 to 90 mm Visual Analog Scale
• Knee pain and related functional reduction for at least 1 month

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
• Symptomatic OA in other joints (i.e. hip, hand)
• Use of narcotics on the day of evaluation
• 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

• Barzilai Medical Center: lead

Study Sites (1)

Barzilai University Medical Center

Ashkelon, Southern District, 7830604, Israel

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Omri Lubovsky, MD

  Barzilai University Medical Center Ashkelon Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Galia Cohen Peres, BA

CONTACT

+972-54-2211779; cohenperesg@bmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Orthopedic Department

Model Details: Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 14, 2025
• Study Start: January 14, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

IL (1)