Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
This study is investigating if adding LightForce laser therapy to standard treatment helps people with common ankle sprains feel less pain. Standard treatment includes RICE (Rest, Ice, Compression, Elevation) and physiotherapy exercises. Researchers want to see if the laser combined with this care works better than when people receive a 'dummy' laser (that doesn't actually treat anything) along with the standard care. The study is particularly looking at mild to moderate ankle sprains that have happened recently. They are also collecting information about how safe and effective the LightForce laser is when used in everyday clinical practice.
At a glance
What is this study about?
Imagine you've sprained your ankle – a painful and common injury. This study is exploring a new way to help reduce that pain. It's looking at a special type of laser therapy called LightForce Therapy Lasers. The main goal is to find out if using this laser along with the usual care, like resting, icing, compressing, and elevating your ankle (RICE), plus physiotherapy exercises, helps you feel better faster than just having the usual care on its own.
To make sure the results are fair, some people in the study will get the real laser treatment, while others will get a 'sham' laser. This sham laser looks and feels like the real thing but doesn't actually deliver any treatment. This helps researchers compare the true effects of the laser. They are focusing on people who have recently sprained their ankle, specifically mild to moderate sprains, and are checking their pain levels.
Beyond just pain relief, this study also has another important purpose. It's gathering information about the safety and overall performance of LightForce Therapy Lasers when used in real-world settings. This helps ensure that medical devices are safe and effective for patients, meeting important health regulations.
Key takeaways
- A study testing a special laser (LightForce) for recent ankle sprains.
- Compares laser therapy plus standard care against standard care alone.
- Aims to see if the laser helps reduce pain effectively and safely.
- Participants will receive either the real laser or a 'dummy' laser.
- Focused on mild to moderate ankle sprains that occurred within 3 days.
Who may be eligible?
To join this study, you need to be 18 years old or older and have a recent ankle sprain (within the last 3 days) that a doctor has confirmed. Your ankle pain should be at a certain level, enough to register on a pain scale.
However, there are reasons you might not be able to take part. For example, if you have other serious health problems that might affect how you do exercises, or if you're pregnant or trying to get pregnant. You also can't join if you have certain existing conditions like chronic ankle instability (meaning you sprain your ankle often), a fracture, active cancer, or some inflammatory conditions like rheumatoid arthritis.
Additionally, if you're taking medications that react badly to heat or light, or have had steroid injections recently, you wouldn't be able to participate. If more than 30% of the skin where the laser would be used is covered by tattoos, or if you're already in another study, you also wouldn't qualify.
- Are you 18 years old or older?
- Did you sprain your ankle in the last 3 days?
- Is your ankle sprain mild to moderate (not a severe break or tear)?
- Do you have a certain level of ankle pain, as assessed by a doctor?
- Are you able to agree to take part in the study in writing?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
The study involves receiving either actual laser therapy or a dummy (sham) laser, alongside standard care for your sprained ankle, which includes RICE (Rest, Ice, Compression, Elevation) and physiotherapy exercises. You will have regular appointments where your pain levels will be assessed. Researchers will also be checking the safety of the laser treatment. The exact number of visits and the total duration aren't fully detailed in this summary, but they will involve treatments and assessments over a period determined by your recovery. More details on the schedule would be provided by the study team.
Potential risks and benefits
Locations (8)
- Carioni FisioterapiaCassano d'Adda, Italy· Recruiting
- CasertafisioCaserta, Italy· Recruiting
- Rachis CenterRoma, Italy· Recruiting
- Fisiolab3Roma, Italy· Recruiting
- Fisioterapia EurRoma, Italy· Recruiting
- Fisioterapia GardenieRoma, Italy· Recruiting
- INDERGAARD PHYSIOTERAPY LtdLeeds, United Kingdom· Completed
- Freedom Care ClinicsManchester, United Kingdom· Recruiting
Common questions
What is RICE for an ankle sprain?
RICE stands for Rest, Ice, Compression, and Elevation. It's a common first-aid treatment for sprains to help reduce swelling and pain.
What is 'sham laser therapy'?
Sham laser therapy looks and feels like the real laser treatment but doesn't actually deliver any light energy. It's used to compare against the real treatment to see if the actual laser has a specific effect.
Will I know if I'm getting the real laser or the sham laser?
No, you won't know because this is a 'single-blind' study. This helps ensure that your expectations don't influence the results.
What kind of ankle sprains are included in this study?
This study is looking at mild to moderate (Grade I or II) ankle sprains that have happened recently – within the last 72 hours.
What is physiotherapy?
Physiotherapy involves exercises and treatments to help restore movement and function after an injury, helping you recover from your ankle sprain.
How to find out more
Elena Arcangeli
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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