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Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis (PBM&KOA-02)

Primary Purpose

Knee Osteoarthritis

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Standard treatment + Active B-Cure laser

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Photobiomodulation, Low-Level Laser Therapy

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
Kellgren & Lawrence classification 2-3
Knee pain on movement 40 to 90 mm Visual Analog Scale
Knee pain and related functional reduction for the last ≥ 3 months
Agrees not to use NSAIDs throughout the experiment

Exclusion Criteria:

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
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.
-

Sites / Locations

Holy Family HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Standard treatment + Active B-Cure laser

Arm Description

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.

Outcomes

Primary Outcome Measures

level of pain

Change from baseline in pain score by VAS

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05357703

First Posted

April 27, 2022

Last Updated

May 26, 2022

Sponsor

Erika Carmel ltd

Collaborators

Holy Family Hospital, Nazareth, Israel

1. Study Identification

Unique Protocol Identification Number

NCT05357703

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 26, 2022 (Anticipated)

Primary Completion Date

May 15, 2023 (Anticipated)

Study Completion Date

August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Erika Carmel ltd

Collaborators

Holy Family Hospital, Nazareth, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Photobiomodulation, Low-Level Laser Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard treatment + Active B-Cure laser

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Standard treatment + Active B-Cure laser

Intervention Description

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.

Primary Outcome Measure Information:

Title

level of pain

Description

Change from baseline in pain score by VAS

Time Frame

one month

Secondary Outcome Measure Information:

Title

Change from baseline in WOMAC score [ time point - 1 month]

Description

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.

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR) Kellgren & Lawrence classification 2-3 Knee pain on movement 40 to 90 mm Visual Analog Scale Knee pain and related functional reduction for the last ≥ 3 months Agrees not to use NSAIDs throughout the experiment Exclusion Criteria: 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 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jehad Khazen, MD

Phone

+972545600095

khazenjehad@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marwan Hadad, MD

Organizational Affiliation

The Holy Family Hospital, Nazareth, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Holy Family Hospital

City

Nazareth

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jehad Khazen, MD

Phone

972545600095

khazenjehad@gmail.com

First Name & Middle Initial & Last Name & Degree

Maroun Yacoub

Phone

+9720543349738

Ext

+9720543349738

maroun@gd-energies.com

12. IPD Sharing Statement

Learn more about this trial

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

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