Using LightForce® Therapy Lasers to Reduce Knee Osteoarthritis Pain
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
This study is testing if using LightForce® Therapy Lasers can help people with knee osteoarthritis feel less pain compared to those who receive a fake laser treatment along with regular physiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | DJO UK Ltd Industry-sponsored |
| Locations | 7 sites (Gresy sur Aix and 6 other locations) |
| Trial ID | NCT06654739 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the effectiveness of LightForce® Therapy Lasers in reducing pain for individuals with knee osteoarthritis. The study compares the outcomes of patients receiving laser therapy combined with standard physiotherapy to those receiving a sham laser treatment alongside the same physiotherapy regimen. It is a multi-center, randomized, sham-controlled, single-blind study designed to gather post-market clinical data on the safety and performance of the laser therapy. Participants will be monitored for pain reduction and overall safety during the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of knee osteoarthritis and moderate pain levels.
Not a fit: Patients with contraindications to laser therapy or those with severe musculoskeletal conditions unrelated to knee osteoarthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate knee osteoarthritis pain, improving patients' quality of life.
How similar studies have performed: Other studies have shown promising results with laser therapy for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gresy sur Aix and 6 other locations
- Cabinet d'Ostéopathie — Gresy sur Aix, France (Recruiting)
- Cabinet Allaire — Le Havre, France (Recruiting)
- Casertafisio — Caserta, Italy (Recruiting)
- Fisioterapia Carioni — Milano, Italy (Recruiting)
- Fisioterapia EUR — Roma, Italy (Recruiting)
- Fisioterapia Gardenie — Roma, Italy (Recruiting)
- Indergaard Physiotherapy — Leeds, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Bernard Bonthoux, Physiotherap — Cabinet d'Ostéopathie
- Study coordinator: Elena Arcangeli
- Email: elena.arcangeli@enovis.com
- Phone: 0039 349 8772528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.