Clinical trial NCT06773676: Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis
Official title: Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Sham-Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Of Knee
Keywords: Osteoarthritis
Knee Osteoarthritis
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in level of pain by VAS
timeFrame: 1month
Secondary outcomes:
measure: Change from baseline in WOMAC score
timeFrame: 1 month
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai University Medical Center
state: Southern Region
Study officials:
affiliation: Barzilai University Medical Center Ashkelon Israel
name: Omri Lubovsky, MD
role: PRINCIPAL_INVESTIGATOR
References: