[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625856":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":61,"collaborators":64,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":96,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Istanbul Nisantasi University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Contextually Fixed Exercise Program","ACTIVE_COMPARATOR","Participants will receive a standardized, evidence-based exercise program for rotator cuff-related shoulder pain delivered twice weekly for 12 weeks, with a structured home exercise component. Contextual elements, including environmental conditions and therapist communication, will be delivered in a fixed, neutral, and standardized manner without personalization.",[13],"Behavioral: Contextually Fixed Exercise Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Contextually Enriched Personalized Exercise Program","EXPERIMENTAL","Participants will receive the same evidence-based exercise program delivered twice weekly for 12 weeks, with a structured home exercise component. Exercise dosage, progression, and therapeutic targets will be identical to the comparator group. In addition, personalized contextual elements will be systematically integrated.",[19],"Behavioral: Contextually Enriched Personalized Exercise Program",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","This structured rehabilitation program includes progressive strengthening, mobility, and motor control exercises based on current clinical guidelines. Exercise dosage, progression criteria, and therapeutic targets are predefined and identical across groups. Environmental conditions, therapist communication style, and feedback are standardized and not individualized.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"This intervention includes the identical structured exercise program delivered twice weekly for 12 weeks with a home component. Exercise type, dosage, progression criteria, and therapeutic targets remain unchanged from the comparator group. Personalized contextual components are systematically integrated, including preferred music and lighting, autonomy-supportive communication, expectancy-enhancing feedback, and choice between biomechanically equivalent exercise alternatives targeting the same therapeutic objectives. These contextual elements do not modify exercise load or treatment goals.",[15],[30],{"name":31,"affiliation":32,"role":33},"Derya ÇELİK, Professor of Physical Therapy","Istanbul University - Cerrahpasa","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Onur Atakan Sekibağ, PhD (c)","CONTACT","90 (212) 210 10 10","onuratakan.sekibag@nisantasi.edu.tr",[41],{"facility":42,"status":25,"city":43,"state":25,"zip":25,"country":44,"countryCode":25,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"İstanbul Nisantasi University","Istanbul","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],28.94966,41.01384,{"lat":49,"lon":48},[52,54,57,58],{"name":53,"role":37,"phone":38,"phoneExt":25,"email":39},"Onu Atakan SEKİBAĞ, PhD(c). PT.",{"name":55,"role":56,"phone":25,"phoneExt":25,"email":25},"Onur Atakan SEKİBAĞ, PhD(c). PT.","PRINCIPAL_INVESTIGATOR",{"name":31,"role":56,"phone":25,"phoneExt":25,"email":25},{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Tolgahan KORKMAZ, Orthopedic Specialist","SUB_INVESTIGATOR",{"type":56,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Onur Atakan Sekibağ","PhD Candidate, Physical Therapist",[65],{"name":32,"class":6},"100625856","contextually-enriched-individualized-exercise-versus-contextually-fixed-exercise-for-rotator-cuff-related-shoulder-pain-100625856",false,"NCT07428070","Contextually Enriched Individualized Exercise Versus Contextually Fixed Exercise for Rotator Cuff-Related Shoulder Pain","Comparison of the Effectiveness of Contextually Enriched Exercise Programs in Rotator Cuff-related Shoulder Pain","CONTEXT-RCRSP","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Clinical diagnosis of rotator cuff-related shoulder pain\n* Shoulder pain duration longer than 3 months\n* Painful arc during shoulder flexion or abduction\n* Positive Neer or Hawkins-Kennedy test\n* Pain during resisted external rotation or abduction, or positive Jobe test\n* Ability to understand and speak Turkish\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Clinical signs of a large rotator cuff tear characterized by marked weakness without pain\n* Other shoulder conditions (e.g., frozen shoulder defined as at least 30 percent passive glenohumeral restriction in two or more directions, advanced osteoarthritis, fracture, dislocation, or severe acromioclavicular joint pathology)\n* Previous shoulder surgery\n* Neurological disorders or significant systemic diseases such as rheumatoid arthritis\n* Current or past history of malignancy\n* Physical or cognitive impairments preventing participation in assessments or intervention sessions\n* Reproduction of shoulder symptoms with active cervical spine movements indicating symptomatic cervical pathology\n* Corticosteroid injection within the previous 6 weeks\n* Participation in other concurrent shoulder treatments during the study","ALL","18 Years","75 Years",{"count":78,"type":79},72,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn whether adding personalized contextual factors to an exercise program can improve pain and function in people with rotator cuff-related shoulder pain. This condition is a common cause of shoulder pain and can limit daily activities.\n\nThe main questions this study aims to answer are:\n\n1. Does a contextually enriched and individualized exercise program lead to greater improvement in upper-limb disability (measured by the QuickDASH questionnaire) compared with a contextually fixed program?\n2. Does it lead to greater reductions in pain intensity (measured by the Numeric Pain Rating Scale) and greater improvements in autonomic nervous system regulation (measured by heart rate variability)?\n3. Does it result in more favorable changes in psychosocial outcomes, exercise adherence, and therapeutic alliance?\n\nResearchers will compare two exercise programs to determine whether adding personalized contextual features enhances treatment effectiveness.\n\nOne group will receive a standardized, evidence-based exercise program delivered in a fixed and neutral manner.\n\nThe other group will receive the same exercise program with added personalized contextual elements, such as:\n\n* Preferred music and lighting\n* Choice between equivalent exercises (without changing exercise type or dosage)\n* Motivational feedback and supportive communication\n* Personalized progress tracking\n\nBoth groups will:\n\n* Attend supervised exercise sessions twice per week for 12 weeks\n* Follow a structured home exercise program\n* Complete questionnaires assessing pain, function, and psychological factors\n* Undergo heart rate variability assessment to evaluate autonomic regulation\n* Be followed for 12 months after treatment\n\nThe researchers expect that integrating personalized contextual elements into exercise therapy may enhance recovery, increase motivation, and improve long-term outcomes.",[85,86,87],"Rotator Cuff Related Shoulder Pain","Shoulder Pain","Rotator Cuff Injuries",[87,86,89,90,91,92,93,94,95],"Contextual Healing","Placebo Effect","Exercise Therapy","Therapeutic Alliance","Treatment Adherence","Pain Catastrophizing","Kinesiophobia","NOT_YET_RECRUITING","2026-04-06",{"date":99,"type":100},"2026-04-09","ACTUAL",{"date":102,"type":79},"2026-05-06",{"date":104,"type":79},"2028-05-06",{"name":5,"class":6},1]