[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636638":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High level laser therapy group","EXPERIMENTAL","High-intensity laser therapy (HILT) will be administered using the HIRO TT device (ASA s.r.l., Italy), based on a solid-state Nd:YAG laser source with near-infrared emission at a wavelength of 1064 nm.\n\nThe treatment protocol consists of 10 sessions delivered on alternate days. Each session will last 60 minutes and will include 15 minutes of laser therapy followed by 45 minutes of conventional physiotherapy.\n\nLaser therapy will be applied to two areas of 10 × 10 cm each, located at the anterolateral and posterior aspects of the shoulder. The treatment will be delivered using a pulsed emission with a frequency of 15 Hz, a total energy of 1000 J, and an energy density of 5 J\u002Fcm². The mean power will range between 6 and 10.5 W, with a peak power between 1 and 3 kW, for a total application time of 8 minutes and 30 seconds.",[13],"Device: High intensity laser therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham laser therapy group","SHAM_COMPARATOR","The sham laser intervention will be delivered using the same HIRO TT device and identical treatment procedures as the active HILT group.\n\nThe same anatomical areas (two treatment areas of 10 × 10 cm located at the anterolateral and posterior aspects of the shoulder) will be targeted, with identical session duration and patient positioning.\n\nDuring sham treatment, the device will remain switched on; however, no therapeutic laser emission will be delivered. This approach is intended to ensure participant blinding by replicating the visual and procedural aspects of the active intervention without providing any active therapeutic effect.",[19],"Other: Sham laser therapy",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","High intensity laser therapy",[9],null,{"type":6,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Sham laser therapy",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Lisa Berti, MD","CONTACT","0516366197","lisa.berti@ior.it",[36],{"facility":5,"status":25,"city":37,"state":25,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"Bologna","40136","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],11.33875,44.49381,{"lat":45,"lon":44},{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100636638","the-effectiveness-of-high-intensity-laser-therapy-after-arthroscopic-shoulder-rotator-cuff-repair-100636638",false,"NCT07568288","The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair.","The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair. A Randomized Controlled Trial","Inclusion Criteria:\n\n* Arthroscopic rotator cuff repair of one shoulder for partial or full-thickness tear\n* Willingness to provide written informed consent\n* Age between 30 and 70 years\n* Pain intensity greater than 40\u002F100 on the Visual Analog Scale\n\nExclusion Criteria:\n\n* Psychiatric disorders\n* Cognitive impairment\n* Rheumatic diseases or Fibromyalgia\n* Vascular diseases\n* Neoplastic diseases\n* Infectious diseases\n* Neurological disorders\n* Hemophilia or bleeding diathesis\n* Use of anticoagulant therapy\n* Presence of a pacemaker\n* History of epileptic seizures\n* Pregnancy or breastfeeding\n* Skin lesions or abrasions at the laser application site\n* Known hypersensitivity to laser therapy or photosensitization\n* Use of photosensitizing medications\n* Tattoo in the treatment area\n* Steroid injections in the target area within the previous 2-3 weeks\n* Recent trauma or injury\n* Suspected conditions in which deep tissue heating is contraindicated\n* Use of analgesic or anti-inflammatory medications during the study period\n* Positive status for human immunodeficiency virus infection","ALL","30 Years","70 Years",{"count":60,"type":61},46,"ESTIMATED","INTERVENTIONAL",[64],"NA","This randomized controlled trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) as an adjunct to conventional rehabilitation in patients undergoing arthroscopic rotator cuff repair.\n\nDespite surgical repair, patients frequently experience postoperative pain, limited range of motion, and delayed functional recovery. Conventional physiotherapy represents the standard of care; however, additional strategies may be needed to optimize outcomes. High-intensity laser therapy has been proposed as a non-invasive intervention with potential analgesic and anti-inflammatory effects, but its effectiveness in the postoperative setting remains unclear.\n\nParticipants will be randomly allocated to one of two groups: an experimental group receiving HILT in addition to conventional physiotherapy, and a control group receiving sham laser therapy combined with the same rehabilitation program. Both groups will undergo standardized rehabilitation sessions including therapeutic exercise.\n\nThe primary outcome is pain intensity, measured using the Visual Analog Scale. Secondary outcomes include shoulder range of motion (active and passive), muscle strength, functional status assessed with the Constant-Murley Score, and patient-reported disability and quality of life measured using the Shoulder Pain and Disability Index and the Quick Disabilities of the Arm, Shoulder and Hand.\n\nAssessments will be conducted at baseline (at the start of rehabilitation), during the intervention period after the fourth (T1), seventh (T2), and tenth (T3) physiotherapy sessions, and at follow-up at 4 months.",[67],"Rotator Cuff Tears",[69,70,71,23,72,73],"Arthroscopic rotator cuff repair","Rotator cuff repair","laser therapy","Rehabilitation","Shoulder pain","NOT_YET_RECRUITING","2026-04-28",{"date":77,"type":78},"2026-05-05","ACTUAL",{"date":80,"type":61},"2026-09",{"date":82,"type":61},"2029-09",{"name":5,"class":6},1]