Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain

Launched by DJO UK LTD · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness of LightForce® Therapy Lasers in reducing pain for people who have suffered from lateral ankle sprains, which can happen during sports or other activities. The researchers want to compare how well these lasers work when used alongside standard treatments, like rest, ice, compression, elevation (commonly known as RICE), and physiotherapy, versus a sham laser treatment (which does not actually provide the therapy) combined with the same standard care. The goal is to see if the LightForce® lasers can provide better pain relief for individuals with mild to moderate ankle injuries.

To participate in this study, you must be at least 18 years old and have been experiencing ankle sprain pain for no more than 72 hours. You should also report a certain level of pain (measured on a scale) to be eligible. However, there are several reasons you might not qualify, such as having certain medical conditions, taking specific medications, or if you've had previous injuries or surgeries that could affect your ankle. If you join the study, you can expect to receive either the LightForce® laser treatment or the sham treatment, along with the standard care for your ankle injury, and you will help gather important information about the safety and effectiveness of this new therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient male or female with age ≥18 years old
• • 2. Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.
• • 3. Patient suffering from LAS pain for no more than 72 hours prior to enrollment
• • 4. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
• • 5. Patient able to provide written informed consent
• Exclusion Criteria:
• • 1. 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
• • 2. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
• • 3. Patients who have been administered with corticosteroids after injury
• • 4. Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
• • 5. Patients who had systemic inflammatory conditions (i.e. rheumatoid arthritis, polymyalgia rheumatica)
• • 6. Patients affected by chronic ankle instability (recurrent sprains, ankle instability, functional ankle instability, mechanical ankle instability fol¬lowing the first-time injury)
• • 7. Patients with bilateral ankle sprain
• • 8. 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)
• • 9. Patients with fractures (as confirmed by radiological examination)
• • 10. Patients with a diagnosis of active cancer
• • 11. Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
• • 12. Patients who are mentally or physically incapacitated
• • 13. Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
• • 14. Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator