[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"shoulder-disability\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:shoulder-disability":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100659152","personalised-education-versus-usual-physiotherapy-for-acute-rotator-cuff-related-shoulder-pain-100659152",false,"NCT07859891","Personalised Education Versus Usual Physiotherapy for Acute Rotator Cuff-Related Shoulder Pain","Clinical and Cost-Effectiveness of a Personalised, Multimodal Educational Intervention Compared With Usual Physiotherapy Care To Reduce Pain And Disability In Adults With Acute Rotator Cuff-Related Shoulder Pain: A Multicentre, Pragmatic, Parallel-Group, Non-Inferiority Randomised Controlled Trial","SHOULD-ER","Inclusion Criteria:\n\n* Age ≥18 years\n* Able to speak and understand French\n* Affiliated with a French health insurance system\n* Available for study follow-up\n* Clinical diagnosis of acute non-traumatic rotator cuff-related shoulder pain of less than 6 weeks' duration: deltoid-region and\u002For upper arm pain; pain associated with arm movement; familiar pain reproduced during resisted external rotation testing\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Previous traumatic shoulder injury potentially causing rotator cuff tear, capsuloligamentous or labral injury, fracture, or dislocation involving the shoulder complex\n* Clinical signs of massive rotator cuff tear\n* Referred or cervical radicular pain\n* Cervical radiculopathy, neuropathic pain or upper-limb neuropathy\n* Frozen shoulder\n* Glenohumeral instability\n* Glenohumeral, acromioclavicular, or sternoclavicular arthropathy\n* Vascular disorders affecting the upper limb\n* Inflammatory rheumatic disease affecting the upper limb\n* Central neurological disease or cancer affecting the shoulder\n* Previous surgery on the painful shoulder\n* Current rehabilitation for the present shoulder episode\n* Opioid use or corticosteroid injection within 3 months or planned at the enrolment\n* Unable to complete questionnaires\n* Participation in another clinical trial\n* Persons under legal protection\n* Administrative or judicial supervision","ALL","18 Years",{"count":20,"type":21},118,"ESTIMATED","INTERVENTIONAL",[24],"NA","Rotator cuff-related shoulder pain (RCRSP) is one of the most common musculoskeletal disorders presenting in primary care. It is frequently associated with persistent pain, disability, healthcare utilisation and work absenteeism. Exercise-based physiotherapy is recommended as first-line management in clinical practice guidelines, yet its average effects on pain and disability are modest and a substantial proportion of people remain symptomatic several months after onset. Patient education is also recommended, and trials conducted in people with persistent symptoms suggest that education-based care may produce improvements comparable to those obtained with progressive exercise. However, the effectiveness of a structured educational intervention as a first-line management strategy during the acute phase of RCRSP remains unclear.\n\nSHOULD Education lead Rehabilitation? (SHOULD-ER) is a multicentre, pragmatic, parallel-group, non-inferiority randomised controlled trial comparing a personalised, multimodal educational intervention with usual physiotherapy care in adults presenting with acute non-traumatic RCRSP of less than six weeks duration. Participants will be randomly assigned to one of the trial arms for a 12-week treatment period, with follow-up to 24 weeks.\n\nThe primary objective is to determine whether the educational intervention is non-inferior to usual physiotherapy care regarding improvement in shoulder pain and disability at 12 weeks, measured by the Shoulder Pain and Disability Index (SPADI). Secondary outcomes include pain-related function, self-efficacy, fear-avoidance beliefs, quality of life, sleep quality, patient satisfaction and healthcare costs.\n\nA nested qualitative study and a within-trial economic evaluation are embedded in the trial. An exploratory analysis of prognostic factors will also be conducted with a secondary analysis.",[27,28,29],"Rotator Cuff-related Shoulder Pain","Shoulder Pain","Shoulder Disability",[31,28,32,33,34,35],"Rotator Cuff-Related Shoulder Pain","Patient Education","Physiotherapy","Self-Management","Primary Health Care","NOT_YET_RECRUITING","2026-09-30",{"date":39,"type":40},"2026-10-06","ACTUAL",{"date":42,"type":21},"2026-10-17",{"date":44,"type":21},"2029-10-17",{"name":46,"class":47},"Centre Hospitalier Régional d'Orléans","OTHER"]