Osteoarthritis of Knee
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICELaser therapy + physiotherapy/exercise protocol
laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol (program includes kinesitherapy, range of motion (ROM) exercises, stretching, strengthening, and flexibility exercises) for 6 consecutive weeks, for a minimum of 2 sessions per week
DEVICESham Laser therapy + physiotherapy/exercise protocol
sham laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol (program includes kinesitherapy, range of motion (ROM) exercises, stretching, strengthening, and flexibility exercises) for 6 consecutive weeks, for a minimum of 2 sessions per week
Sponsors
Donawa Lifescience Consulting SRL
DJO UK Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized, sham controlled, single blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain change | 6 weeks after treatment start | Pain reduction measured with Visual Analog Scale (VAS) (0-100 mm) after 6 weeks of treatment compared to pre-treatment (baseline) VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - adverse event rate | through study completion, an average of 12 weeks | Proportion of patient experiencing an adverse event associated with device use |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient overall status change | 2, 4, 6 ans 12 weeks after treatment start | Patient ratings of overall improvement, assessed by QoL (SF-12): The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses 12 items and scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. SF-12 will be assessed at 2, 4, 6 weeks and at 12 weeks and compared to baseline |
| pain change | 2, 4, 9 and 12 after treatment start | Pain measured with Visual Analog Scale (VAS) (0-100 mm) at 2, 4, 9 and 12 weeks after treatment start to assess short-term and long-term pain management compared to baseline |
| rate of patients needed new treatment | 18 weeks after treatment start | Patients will be asked through a questionnaire whether any new treatment and in case which one (pharmacological, physiotherapic etc) was needed to manage knee osteoarthritis pain since12 weeks after treatment start |
| Physical function | 2, 4, 6 and 12 weeks after treatment start | Physical functional test (30 seconds chair-rise test) assessed at 2, 4, 6 and at 12 weeks, compared to baseline. |
| Joint stiffness and function | 2, 4, 6 ans 12 weeks after treatment start | Joint stiffness and function measured with KOOS - Knee Injury and Osteoarthritis Outcome Score \[that consists of five sub-scales: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items)\]; Quality of Life (four items) for a totoal of 42 items. KOOS max score is 100 and minimum is 0 where zero representing extreme knee problems and 100 representing no knee problem. KOOS will be assessed at 2, 4, 6 and at 12 weeks and compared to baseline. |
Countries
France, Italy, United Kingdom
Outcome results
None listed