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

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Device: Standard treatment + Active B-Cure laser

• Registration Number: NCT05357703
• Lead Sponsor: Erika Carmel ltd

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Study Start: 2022-05-26
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-06-01
• Primary Completion: 2023-05-15
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard treatment + Active B-Cure laser	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.

Primary Outcome Measures

Name	Time	Method
level of pain	one month	Change from baseline in pain score by VAS

Secondary Outcome Measures

Name	Time	Method
Change from baseline in WOMAC score [ time point - 1 month]	one 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.

Trial Locations

Locations (1)

Holy Family Hospital; 🇮🇱 Nazareth, Israel