rct on the performance and safety of lightforce® therapy lasers on knee osteoarthritis pain reduction (spark)

Conditions: Osteoarthritis of Knee

Summary: djo uk ltd (enovis) is conducting this study to assess the effectiveness of lightforce® therapy lasers on pain reduction in subjects with unilateral or bilateral knee osteoarthritis. in detail this study will assess superiority of lightforce® therapy lasers combined with standard of care, represented by physiotherapy/exercise program compared to sham laser combined with standard of care (physiotherapy/exercise program) on pain reduction in subjects with knee osteoarthritis. in addition, this study allows to collect post market clinical data on the safety and performance of lightforce® therapy lasers, when used, following the normal clinical practice, in accordance with its approved and ce marked intended use.

this clinical investigation is a post-market, international, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of lightforce® therapy lasers and to collect pmcf data on the safety and performance of lightforce® therapy lasers, when used in accordance with its approved labeling, to comply with medical device regulation (eu) 2017/745 (mdr) article 61 and part b of annex xi.

Eligibility criteria:
inclusion criteria: * patient male or female with age ≥18 years old * patient with radiographic diagnosis of knee osteoarthritis (as confirmed by x- ray or ct scan) to be treated by lightforce® therapy lasers according its indications. * patient with kellgren and lawrence grade 2-3 unilateral or bilateral knee osteoarthritis * patient suffering from knee osteoarthritis pain for more than 6 months prior to enrollment * pain (either persistent or during activities) score reported by the subject at baseline ≥ 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 beneficiary of such system exclusion criteria: * patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of lightforce® therapy lasers according to its intended 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 treatment at least 2 weeks prior to study treatment start * pregnant females or females of childbearing potentially planning to become pregnant during the study participation * patients who had inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis) * patients who underwent intra-articular injection (ialuronic acid, platelet rich plasma 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, cerebrovascular event history) * patients who have hip or ankle/foot joint pathology that might interfere with participation in exercises/knee recovery * patients with a diagnosis of active cancer * patients with tattoos covering more than 30% of the area to be treated with lightforce® therapy lasers * patients who are mentally or physically incapacitated * patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment * patients with other musculoskeletal problems of the knee joint such as tendon or ligament injury, recent surgery, recent fracture, or recent meniscus injury and/or undergoing to specific physiotherapy for these ("recent" is defined as within 30 days prior to enrollment) * patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator.