Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT06854016
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06854016
Study Brief:
Protocol Section:
NCT06854016