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

NCT06654739 | Active Not Recruiting

• 1 other identifier: ENOVIS-S-INP-0001
• Study Type: interventional
• Target: 64
• Locations: 3 countries
• Sites: 7

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.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety - adverse event rate

  through study completion, an average of 12 weeks

Other Outcomes (6)

• pain change

  2, 4, 9 and 12 after treatment start

• Joint stiffness and function

  2, 4, 6 ans 12 weeks after treatment start

• Patient overall status change

  2, 4, 6 ans 12 weeks after treatment start

Study Arms (2)

Treatment arm 1

SHAM COMPARATOR

Sham laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol

Device: Sham Laser therapy + physiotherapy/exercise protocol

Treatment arm 2

ACTIVE COMPARATOR

Laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol

Device: Laser therapy + physiotherapy/exercise protocol

Interventions

Laser therapy + physiotherapy/exercise protocol DEVICE

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

Treatment arm 2

Sham Laser therapy + physiotherapy/exercise protocol DEVICE

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

Treatment arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DJO UK Ltd: lead
• Donawa Lifescience Consulting SRL: collaborator

Study Sites (7)

Cabinet d'Ostéopathie

Grésy-sur-Aix, 73100, France

Location

Cabinet Allaire

Le Havre, 76600, France

Location

Casertafisio

Caserta, Italy

Location

Fisioterapia Carioni

Milan, Italy

Location

Fisioterapia EUR

Roma, Italy

Location

Fisioterapia Gardenie

Roma, Italy

Location

Indergaard Physiotherapy

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Laser Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Rehabilitation

Study Officials

• Bernard Bonthoux, Physiotherap

  Cabinet d'Ostéopathie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, sham controlled, single blind

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 23, 2024
• Study Start: November 23, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); GB (1); IT (4)