Clinical trial NCT06654739: RCT on the Performance and Safety of LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction (SPARK)
Official title: Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: DJO UK Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, sham controlled, single blind
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain change
timeFrame: 6 weeks after treatment start
Secondary outcomes:
measure: Safety - adverse event rate
timeFrame: through study completion, an average of 12 weeks
Other outcomes:
measure: pain change
timeFrame: 2, 4, 9 and 12 after treatment start
measure: Joint stiffness and function
timeFrame: 2, 4, 6 ans 12 weeks after treatment start
measure: Patient overall status change
timeFrame: 2, 4, 6 ans 12 weeks after treatment start
measure: Physical function
timeFrame: 2, 4, 6 and 12 weeks after treatment start
measure: pain change
timeFrame: 18 weeks after treatment start
measure: rate of patients needed new treatment
timeFrame: 18 weeks after treatment start
Locations:
city: Gresy sur Aix
country: France
facility: Cabinet d'Ostéopathie
city: Le Havre
country: France
facility: Cabinet Allaire
city: Caserta
country: Italy
facility: Casertafisio
city: Milano
country: Italy
facility: Fisioterapia Carioni
city: Roma
country: Italy
facility: Fisioterapia EUR
city: Roma
country: Italy
facility: Fisioterapia Gardenie
city: Leeds
country: United Kingdom
facility: Indergaard Physiotherapy
Study officials:
affiliation: Cabinet d'Ostéopathie
name: Bernard Bonthoux, Physiotherap
role: PRINCIPAL_INVESTIGATOR
References: