Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
NCT ID: NCT06854016
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2025-04-11
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sham Laser treatment - Arm 1
Sham Laser therapy
Sham Laser therapy
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.
RICE and physiotherapy/exercise protocol
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.
Laser Treatment - Arm 2
Laser therapy
Laser therapy
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
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.
Interventions
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Sham Laser therapy
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
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
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Donawa Lifescience Consulting SRL
UNKNOWN
DJO UK Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Carioni Fisioterapia
Cassano d'Adda, Milano, Italy
Casertafisio
Caserta, , Italy
Rachis Center
Roma, , Italy
Fisiolab3
Roma, , Italy
Fisioterapia Eur
Roma, , Italy
Fisioterapia Gardenie
Roma, , Italy
INDERGAARD PHYSIOTERAPY Ltd
Leeds, , United Kingdom
Freedom Care Clinics
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ENOVIS-S-INP-0011
Identifier Type: -
Identifier Source: org_study_id
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