Active not recruitingNAINTERVENTIONAL

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

This study is investigating a new laser treatment called LightForce® Therapy for people with knee osteoarthritis, a common condition causing joint pain. Researchers want to see if this laser, when used alongside a typical exercise program, is better at reducing pain than an exercise program combined with a 'sham' (fake) laser. The main goal is to find out if the LightForce® Therapy Lasers are effective for pain relief. The study will also collect information on how safe and well the laser works when used in a real-world setting, following its approved guidelines. This helps ensure treatments are safe and meet important medical device regulations.

At a glance

Status

Active not recruiting

Phase

Sponsor

DJO UK Ltd

Enrolment target

Start

23 Nov 2024

Estimated completion

30 Mar 2026

Osteoarthritis of Knee

What is this study about?

This research study is about helping people who have knee osteoarthritis, which is a condition where the cartilage in your knee joint wears down, causing pain and stiffness. The study wants to find out if a specific type of laser treatment, called LightForce® Therapy, can help reduce this pain.

To do this, some people in the study will receive the LightForce® Therapy laser treatment plus a regular physiotherapy and exercise plan. Other people will get a 'sham' (fake) laser treatment that looks and feels like the real thing, but doesn't actually deliver any laser energy, also combined with the same physiotherapy and exercise. This comparison helps the researchers see if any benefits are truly from the laser itself, rather than just the exercise or the expectation of feeling better.

The study also aims to gather more information on how safe the LightForce® Therapy Lasers are and how well they perform in general use, making sure they continue to meet important safety standards for medical devices.

Key takeaways

Tests a laser treatment for knee osteoarthritis pain.
Compares real laser + exercise to fake laser + exercise.
Aims to reduce pain for people with knee osteoarthritis.
Also checks safety and performance of the laser device.
Participation requires regular visits for treatment and assessment.

Who may be eligible?

To join this study, you need to be at least 18 years old and have knee osteoarthritis in one or both knees that has been causing you pain for more than six months. Your doctor would have confirmed this diagnosis with an X-ray or CT scan, and your pain level needs to be at a certain minimum point when the study starts. You also need to be able to give written permission to take part, and your body mass index (BMI) should be 30 or less.

There are several reasons why you might not be able to join. For example, if you have other muscle or joint conditions that aren't suitable for laser therapy, or if you're taking medications that react badly to heat or light (like some steroids). If you've had certain injections in your knee (like hyaluronic acid or corticosteroids) in the last six months, you can't join. Also, pregnant women or those planning to become pregnant during the study, people with inflammatory arthritis (like rheumatoid arthritis), or those with active cancer cannot participate. If you have other serious health problems that would stop you from exercising, or large tattoos in the area to be treated, you also wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have knee osteoarthritis with pain lasting over 6 months?
Is your body mass index (BMI) 30 or less?
Are you able to attend appointments and follow an exercise plan?
Are you *not* pregnant or planning to be during the study?
Have you *not* had knee injections in the last 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two groups: either the group receiving the actual LightForce® Therapy laser combined with physiotherapy/exercise, or the group receiving a 'sham' (fake) laser combined with the same physiotherapy/exercise. You won't know which group you are in. You will attend regular sessions for your laser (or sham laser) treatment and continue with your prescribed exercises. Researchers will regularly check your pain levels and how your knee is feeling. The total number of visits and the exact duration of the study would be explained in detail by the study team, but it will involve consistent appointments for treatment and follow-up assessments.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of reduced knee pain if the LightForce® Therapy laser proves effective, even if you are in the sham laser group, the physiotherapy and exercise may still be helpful. Potential risks associated with the laser treatment are generally low; however, as with any medical device, there's always a small chance of unexpected side effects, which the study team would monitor closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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

Common questions

What is osteoarthritis?

Osteoarthritis is a common joint condition where the protective cartilage on the ends of your bones wears down over time, causing pain, swelling, and stiffness.

What is a 'sham' laser therapy?

A sham laser therapy is a fake treatment that looks and feels like the real laser, but doesn't deliver any active treatment. It helps researchers compare the real treatment's effects more fairly.

Will I know if I'm getting the real laser or the sham laser?

No, this is a 'single-blind' study, meaning you won't know whether you are receiving the real laser or the sham laser. This helps ensure unbiased results.

Do I have to do exercises too?

Yes, everyone in the study will be doing a physiotherapy and exercise program alongside either the real laser or the sham laser treatment.

What does a 'clinical investigation' mean?

A clinical investigation means researchers are carefully studying a medical device, like this laser, to see how well it works and if it's safe for patients.