[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581723":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":142,"collaborators":144,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":26,"enrollmentInfo":158,"targetDuration":26,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"DJO UK Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham Laser treatment - Arm 1","SHAM_COMPARATOR","Sham Laser therapy",[13,14],"Device: Sham Laser therapy","Other: RICE and physiotherapy\u002Fexercise protocol",{"label":16,"type":17,"description":18,"interventionNames":19},"Laser Treatment - Arm 2","ACTIVE_COMPARATOR","Laser therapy",[20,14],"Device: Laser therapy",[22,27,30],{"type":23,"name":11,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":23,"name":18,"description":28,"armGroupLabels":29,"otherNames":26},"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.",[16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"OTHER","RICE and physiotherapy\u002Fexercise protocol","RICE plus physiotherapy\u002Fexercise 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\u002Fexercise protocol will be performed at site with 2 sessions per week.",[16,9],[36],{"name":37,"affiliation":38,"role":39},"Ove Indergaard, Physiotherap","ove@indergaardphysio.com","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Elena Arcangeli","CONTACT","3498772528","elena.arcangeli@enovis.com",[47,64,76,89,98,107,119,130],{"facility":48,"status":49,"city":50,"state":51,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Carioni Fisioterapia","RECRUITING","Cassano d'Adda","Milano","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],9.51528,45.52637,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":26,"phoneExt":26,"email":63},"CRISTIANO IVAN CARIONI, Physiotherap","cristianoivan72@gmail.com",{"facility":65,"status":49,"city":66,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Casertafisio","Caserta",{"type":55,"coordinates":68},[69,70],14.33231,41.07262,{"lat":70,"lon":69},[73],{"name":74,"role":43,"phone":26,"phoneExt":26,"email":75},"Gian Paolo Papiro, Physiotherap","g.papiro@gmail.com",{"facility":77,"status":49,"city":78,"state":26,"zip":79,"country":52,"countryCode":53,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Rachis Center","Roma","00199",{"type":55,"coordinates":81},[82,83],11.10642,44.99364,{"lat":83,"lon":82},[86],{"name":87,"role":43,"phone":26,"phoneExt":26,"email":88},"Stamatios Liaskos, Med. 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Patient male or female with age ≥18 years old\n2. Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.\n3. Patient suffering from LAS pain for no more than 72 hours prior to enrollment\n4. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS\n5. Patient able to provide written informed consent\n\nExclusion Criteria:\n\n1. Patient with musculoskeletal pathological conditions not to be treated with\u002Fcontraindication to the use of LightForce® Therapy Lasers according to its intended use and indications\n2. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids\n3. Patients who have been administered with corticosteroids after injury\n4. Pregnant females or females of childbearing potentially planning to become pregnant during the study participation\n5. Patients who had systemic inflammatory conditions (i.e. rheumatoid arthritis, polymyalgia rheumatica)\n6. Patients affected by chronic ankle instability (recurrent sprains, ankle instability, functional ankle instability, mechanical ankle instability fol¬lowing the first-time injury)\n7. Patients with bilateral ankle sprain\n8. 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)\n9. Patients with fractures (as confirmed by radiological examination)\n10. Patients with a diagnosis of active cancer\n11. Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers\n12. Patients who are mentally or physically incapacitated\n13. Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment\n14. Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator","ALL","18 Years",{"count":159,"type":160},108,"ESTIMATED","INTERVENTIONAL",[163],"NA","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\u002For sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy\u002Fexercise program, compared to sham laser combined with standard of care (RICE and physiotherapy\u002Fexercise 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.",[166,167,168],"Ankle Sprain 1St Degree","Ankle Sprain 2Nd Degree","Acute Pain",[170],"lateral acute grade I and II ankle sprain, pain, laser","2025-11-14",{"date":173,"type":174},"2025-11-17","ACTUAL",{"date":176,"type":174},"2025-04-11",{"date":178,"type":160},"2026-09",{"name":5,"class":6},8]