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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis of Knee
• Intervention / Treatment: Device: Sham Laser therapy + physiotherapy/exercise protocol; Device: Laser therapy + physiotherapy/exercise protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grésy-sur-Aix, France, 73100
    • Cabinet d'Ostéopathie
  • Le Havre, France, 76600
    • Cabinet Allaire
• Italy
  • Caserta, Italy
    • Casertafisio
  • Milan, Italy
    • Fisioterapia Carioni
  • Roma, Italy
    • Fisioterapia EUR
  • Roma, Italy
    • Fisioterapia Gardenie
• United Kingdom
  • Leeds, United Kingdom
    • Indergaard Physiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Treatment arm 1; Sham laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol	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
Active Comparator: Treatment arm 2; Laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain change	Pain reduction measured with Visual Analog Scale (VAS) (0-100 mm) after 6 weeks of treatment compared to pre-treatment (baseline) VAS	6 weeks after treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - adverse event rate	Proportion of patient experiencing an adverse event associated with device use	through study completion, an average of 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain change	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	2, 4, 9 and 12 after treatment start
Joint stiffness and function	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.	2, 4, 6 ans 12 weeks after treatment start
Patient overall status change	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	2, 4, 6 ans 12 weeks after treatment start
Physical function	Physical functional test (30 seconds chair-rise test) assessed at 2, 4, 6 and at 12 weeks, compared to baseline.	2, 4, 6 and 12 weeks after treatment start
pain change	pain measured with Visual Analog Scale (VAS) (0-100 mm) to assess post study pain change (for those patients who did not initiate a new treatment for knee osteoarthritis pain after week 12 and within week 18)	18 weeks after treatment start
rate of patients needed new treatment	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	18 weeks after treatment start

Collaborators and Investigators

• Sponsor: DJO UK Ltd
• Collaborators: Donawa Lifescience Consulting SRL
• Investigators: Principal Investigator: Bernard Bonthoux, Physiotherap, Cabinet d'Ostéopathie

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2024
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Therapeutics; Surgical Procedures, Operative; Rehabilitation; Ablation Techniques; Physical Therapy Modalities; Laser Therapy
• Other Study ID Numbers: ENOVIS-S-INP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes