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

Knee Osteoarthritis Clinical Trial

— PBM&KOA-02  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357703
• Other study ID #: HFH-256-2022
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: April 2022
• Source: Erika Carmel ltd
• Contact: Jehad Khazen, MD
• Phone: +972545600095
• Email: khazenjehad[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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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Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Standard treatment + Active B-Cure laser
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.

Locations

Country	Name	City	State
Israel	Holy Family Hospital	Nazareth

Sponsors (2)

Lead Sponsor	Collaborator
Erika Carmel ltd	Holy Family Hospital, Nazareth, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of pain	Change from baseline in pain score by VAS	one month
Secondary	Change from baseline in WOMAC score [ time point - 1 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.	one month