RCT on the Performance and Safety of LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction (SPARK)

Inclusion Criteria:

• Patient male or female with age ≥18 years old

• Patient with radiographic diagnosis of knee osteoarthritis (as confirmed by x- rayor CT scan) to be treated by LightForce® Therapy Lasers according its indications.

• Patient with Kellgren and Lawrence grade 2-3 unilateral or bilateral kneeosteoarthritis

• Patient suffering from knee osteoarthritis pain for more than 6 months prior toenrollment

• Pain (either persistent or during activities) score reported by the subject atbaseline ≥ 40 mm measured on VAS

• Patient able to provide written informed consent

• Patient with BMI ≤30 kg/m2

• For FRANCE ONLY: To be affiliated to the social security system or to be beneficiaryof such system

Exclusion Criteria:

• Patient with musculoskeletal pathological conditions not to be treatedwith/contraindication to the use of LightForce® Therapy Lasers according to itsintended use and indications

• Patients who are taking drugs that have heat or light sensitive contraindications,such as but not limited to certain types of steroids

• Patients who are administered with corticosteroids, should discontinue the treatmentat least 2 weeks prior to study treatment start

• Pregnant females or females of childbearing potentially planning to become pregnantduring the study participation

• Patients who had inflammatory arthritis (i.e. rheumatoid arthritis, psoriaticarthritis)

• Patients who underwent intra-articular injection (Ialuronic acid, platelet richplasma or corticosteroids) in the knee in the last 6 months

• Patients who have a disease that would limit their participation in exercises (i.e.severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascularevent history)

• Patients who have hip or ankle/foot joint pathology that might interfere withparticipation in exercises/knee recovery

• Patients with a diagnosis of active cancer

• Patients with tattoos covering more than 30% of the area to be treated withLightForce® Therapy Lasers

• Patients who are mentally or physically incapacitated

• Patient participating in other clinical study or has completed a clinical study lessthan 30 days prior to enrollment

• Patients with other musculoskeletal problems of the knee joint such as tendon orligament injury, recent surgery, recent fracture, or recent meniscus injury and/orundergoing to specific physiotherapy for these ("recent" is defined as within 30days prior to enrollment)

• Patients with other clinically significant co-morbidities that make the patientunsuitable for study participation, at the discretion of the investigator.