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Active, not recruiting Not applicable

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

NCT06654739 · tracked via the Priya Life Science Italy tracker
Sponsor
DJO UK Ltd
Phase
Not applicable
Started
2024-11-23
Last updated
2025-11-17

Condition(s) studied

Osteoarthritis of Knee

Investigational drug(s) / intervention(s)

Laser therapy + physiotherapy/exercise protocolSham Laser therapy + physiotherapy/exercise protocol

Laser 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

Sham 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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (7)

FacilityCityRegionStatus
Cabinet d'Ostéopathie Grésy-sur-Aix France
Cabinet Allaire Le Havre France
Casertafisio Caserta Italy
Fisioterapia Carioni Milan Italy
Fisioterapia EUR Roma Italy
Fisioterapia Gardenie Roma Italy
Indergaard Physiotherapy Leeds United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06654739 on ClinicalTrials.gov ↗ ← All trials in Italy