Osteoarthritis of KneeSPARKNCT06654739
RCT on the Performance and Safety of LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction (SPARK)
A study testing Laser therapy + physiotherapy/exercise protocol in people with Osteoarthritis of Knee, run by DJO UK Ltd at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Laser therapy + physiotherapy/exercise protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 23 Nov 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Italy4 sites
Casertafisio
Caserta
Fisioterapia Carioni
Milan
Fisioterapia EUR
Roma
Fisioterapia Gardenie
Roma
France2 sites
Cabinet d'Ostéopathie
Grésy-sur-Aix, 73100
Cabinet Allaire
Le Havre, 76600
About this study
Official title: 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.
Read the 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
- Being tested
- Laser therapy + physiotherapy/exercise protocol, Sham Laser therapy + physiotherapy/exercise protocol
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapy + physiotherapy/exercise protocolDevice
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
Sham Laser therapy + physiotherapy/exercise protocolDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm 1 | Sham comparator | Sham laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol Receives: Device: Sham Laser therapy + physiotherapy/exercise protocol |
| Treatment arm 2 | Active comparator | Laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol Receives: Device: Laser therapy + physiotherapy/exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change
Pain reduction measured with Visual Analog Scale (VAS) (0-100 mm) after 6 weeks of treatment compared to pre-treatment (baseline) VAS
Measured: 6 weeks after treatment start
Secondary outcomes (1)
Safety - adverse event rate
Proportion of patient experiencing an adverse event associated with device use
Measured: through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start23 Nov 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, sham controlled, single blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- DJO UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
- Investigators
- Bernard Bonthoux, Physiotherap, Principal investigator, Cabinet d'Ostéopathie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654739
- Sponsor's protocol ID
- ENOVIS-S-INP-0001
- Acronym
- SPARK
- Status last verified
- Nov 2025
- First submitted
- 18 Oct 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06654739
- Acronym / sponsor ID
- SPARK / ENOVIS-S-INP-0001
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- DJO UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 23 Nov 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, sham controlled, single blind
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1 | Sham comparator | Device: Sham Laser therapy + physiotherapy/exercise protocolSham laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol |
| Treatment arm 2 | Active comparator | Device: Laser therapy + physiotherapy/exercise protocolLaser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser therapy + physiotherapy/exercise protocollaser 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 | Treatment arm 2 |
| Sham Laser therapy + physiotherapy/exercise protocolsham 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 | Treatment arm 1 |
Primary outcome
Pain change
Time frame: 6 weeks after treatment start
Pain reduction measured with Visual Analog Scale (VAS) (0-100 mm) after 6 weeks of treatment compared to pre-treatment (baseline) VAS
1 secondary outcome
Safety - adverse event rate
Time frame: through study completion, an average of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Bonthoux, Physiotherap principal investigator
Cabinet d'Ostéopathie
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy + physiotherapy/exercise protocol in people with Osteoarthritis of Knee, run by DJO UK Ltd at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change (time frame: 6 weeks after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.