Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Acute Pain
In brief
DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and/or sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy/exercise program, compared to sham laser combined with standard of care (RICE and physiotherapy/exercise program) on pain reduction in subjects with acute grade I - II lateral ankle sprain. 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.
Key facts
- Study ID
- NCT06854016
- Run by
- DJO UK Ltd
- People needed
- 108
- Starts
- 2025-04-11
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-11-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient male or female with age ≥18 years old
- Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.
- Patient suffering from LAS pain for no more than 72 hours 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
You may not qualify if…
- 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 have been administered with corticosteroids after injury
- Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
- Patients who had systemic inflammatory conditions (i.e. rheumatoid arthritis, polymyalgia rheumatica)
- Patients affected by chronic ankle instability (recurrent sprains, ankle instability, functional ankle instability, mechanical ankle instability fol¬lowing the first-time injury)
- Patients with bilateral ankle sprain
- 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 with fractures (as confirmed by radiological examination)
- 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 clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator
Where it is running
- Freedom Care Clinics — Manchester, United Kingdom (enrolling)
- Casertafisio — Caserta, Italy (enrolling)
- Rachis Center — Roma, Italy (enrolling)
- Fisiolab3 — Roma, Italy (enrolling)
- Fisioterapia Eur — Roma, Italy (enrolling)
- Fisioterapia Gardenie — Roma, Italy (enrolling)
- Carioni Fisioterapia — Cassano d'Adda, Milano, Italy (enrolling)
- INDERGAARD PHYSIOTERAPY Ltd — Leeds, United Kingdom
Full record on ClinicalTrials.gov
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