Clinical trial NCT05357703: Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Photobiomodulation
Low-Level Laser Therapy
Lead sponsor: Erika Carmel ltd
Sponsor class: OTHER
Collaborators: name: Holy Family Hospital, Nazareth, Israel
First posted: 2022-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 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.

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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Primary outcomes:
measure: level of pain
timeFrame: one month
Secondary outcomes:
measure: Change from baseline in WOMAC score [ time point - 1 month]
timeFrame: one month
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Holy Family Hospital
Study officials:
affiliation: The Holy Family Hospital, Nazareth, Israel
name: Marwan Hadad, MD
role: PRINCIPAL_INVESTIGATOR
References: