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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-23

Study Completion Date

2026-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment

NCT03270488

Thumb Osteoarthritis Pain Physical Disorder

COMPLETED NA

Subchondral and Intra-articular Application of Bone Marrow Concentrate for Knee Unicompartmental OA

NCT03790189

Osteoarthritis, Knee Cartilage Degeneration

UNKNOWN NA

Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA

NCT00782197

Joint Disease

COMPLETED PHASE4

Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

NCT04567732

Bilateral Knee Osteoarthritis Autologous Adipose Tissue

ACTIVE_NOT_RECRUITING NA

Platelet Rich Plasma Versus Corticosteroids in Knee Osteoarthritis Pain

NCT06703970

Knee Osteoarthritis (OA)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, sham controlled, single blind

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment arm 1

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

Group Type SHAM_COMPARATOR

Sham Laser therapy + physiotherapy/exercise protocol

Intervention Type 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 2

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

Group Type ACTIVE_COMPARATOR

Laser therapy + physiotherapy/exercise protocol

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No