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Tests treatment safety and results for Ankle Sprain 1St Degree
Official title Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
ClinicalTrials.gov ID: NCT06854016
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of LightForce® Therapy Lasers according to...
- 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...
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cassano d'Adda, Milano, Italy
- Caserta, Italy
- Roma, Italy
- Leeds, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cassano d'Adda, Milano, Italy; Caserta, Italy; Roma, Italy; Leeds, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.