NCT06654739

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: DJO UK Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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

Timeline

• Start date: 2024-11-23
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2024-10-23
• Last updated: 2025-11-17

Locations

7 sites across 3 countries: France, Italy, United Kingdom