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

Launched by DJO UK LTD · Oct 21, 2024

Keywords

ClinConnect Summary

The SPARK trial is a study aimed at understanding how well LightForce® Therapy Lasers can help reduce pain in people with knee osteoarthritis, a common condition that causes joint pain and stiffness. The researchers want to see if using these lasers, along with regular physiotherapy exercises, is more effective at relieving pain than using a fake (sham) laser treatment combined with the same exercises. If you have knee osteoarthritis and have been living with pain for over six months, you might be eligible to participate in this study.

To take part, you need to be at least 18 years old and have a confirmed diagnosis of knee osteoarthritis, as shown by an X-ray or CT scan. Participants will receive treatment in a way that's safe and follows standard medical practices. Throughout the trial, you can expect to undergo some sessions with the therapy laser while also continuing your prescribed exercise program. It's important to know that certain health conditions or treatments may prevent you from participating, so the study team will review your medical history to ensure you're a good fit.

Gender

ALL

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.