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

This clinical investigation is a post-market, International, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of LightForce® Therapy Lasers and to collect PMCF data on the safety and performance of LightForce® Therapy Lasers when used in accordance with its approved labeling, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

• Sham Laser therapy (Device): sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
• Laser therapy (Device): laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
• RICE and physiotherapy/exercise protocol (Other): RICE plus physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes: for the first 2 weeks RICE protocol performed daily at home by the patient, for the following 4 weeks a physiotherapy/exercise protocol will be performed at site with 2 sessions per week.

Primary outcomes

• Pain change [2 weeks after treatment start]: Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) after 4 weeks of treatment compared to pre-treatment (baseline) VAS

Secondary outcomes

• Safety - adverse event rate [through study completion, an average of 12 weeks]: Proportion of patient experiencing an adverse event associated with device use

Other outcomes

• Pain change [1,3,4, 6 and 12 weeks after treatment start]: Pain measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) at 1,3,4, 6 and 12 weeks after treatment start to assess short-term and long-term pain management compared to baseline
• Ankle pain and Disability [1, 2, 3, 4, 6 and at 12 weeks after treatment start]: Ankle pain and disability measured with the Foot and Ankle Disability Index (FADI) questionnaire (the score output is given as a percentace) and the highest the percentage the better is the clinical outome, the lowest the percentage the worse is the clinical outcome; performed at 1, 2, 3, 4, 6 and at 12 weeks after treatment start compared to baseline.
• Patient overall status change [2, 4, 6 ans 12 weeks after treatment start]: Patient ratings of overall improvement, assessed by QoL (SF-12): The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses 12 items and scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. SF-12 will be assessed at 2, 4, 6 weeks and at 12 weeks and compared to baseline
• Range of motion (ROM) of the ankle [1, 2, 3, 4, 6 and 12 weeks after treatment start]: Range of motion for the ankle (flex-extension) measured by a universal goniometer at 1,2, 4, 6 and 12 weeks after treatment start compared to baseline
• Return to pre-injury activity/sport level [2, 3, 4, 6 and 12 weeks after treatment start]: Return to pre-injury activity/sport level measured on a 1 to 5 Likert scale at 2, 3, 4 ,6 and 12 weeks. This will be assessed as time-to-recovery: time after injury needed for the patient to reach the pre injury/sport level.

Sex: All, ages: 18 Years to any

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

• Ove Indergaard, Physiotherap, Principal investigator, ove@indergaardphysio.com