[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657433":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":24,"overallOfficials":24,"centralContacts":34,"locations":44,"responsibleParty":81,"collaborators":85,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":24,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":24,"studyType":103,"phases":24,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":114,"whyStopped":24,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Istanbul Physical Medicine Rehabilitation Training and Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Psychometric Properties of the Night Pain Module","The validity and reliability of the final Night Pain Module will be evaluated. Content validity will be examined using item-level and scale-level content validity indices. Structural validity will be assessed using exploratory and confirmatory factor analyses. Internal consistency will be evaluated using Cronbach's alpha and item-total correlations. Test-retest reliability will be assessed using the intraclass correlation coefficient in clinically stable participants who complete the module again after 7-10 days.","Baseline and 7-10 days after baseline for the retest subgroup",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Relationship Between Night Pain Module Scores and Sleep Quality","Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, which has a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The relationship between Night Pain Module scores and sleep quality will be examined. Module scores will also be compared between participants with better and poorer sleep quality.","Baseline",{"measure":19,"description":20,"timeFrame":17},"Relationship Between Night Pain Module Scores and Shoulder Pain and Disability","Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. Its total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability. Daytime shoulder pain intensity will also be measured using an 11-point numerical rating scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. The relationships of Night Pain Module scores with shoulder pain, disability, and daytime pain intensity will be examined.",{"measure":22,"description":23,"timeFrame":17},"Relationship Between Night Pain Module Scores and Pain Catastrophizing","Pain catastrophizing will be assessed using the Pain Catastrophizing Scale. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing. The relationship between Night Pain Module scores and pain catastrophizing will be examined to evaluate whether the module reflects cognitive and emotional features associated with the pain experience.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Night pain is an important symptom in rotator cuff-related shoulder pain. It may affect falling asleep, cause waking during the night, increase the need to change position, and make it difficult to return to sleep. Pain may also increase when the person lies on the affected shoulder. These features may not be fully described by a single pain score. This study aims to develop a short and practical Night Pain Module that can assess the different features of night pain in clinical practice and research.\n\nThe current draft of the Night Pain Module contains eight items. These items assess difficulty falling asleep because of shoulder pain, the number of nights with pain-related waking, pain intensity at the time of waking, average shoulder pain during the night, increased pain when lying on the affected shoulder, pain relief after changing position, the need to change position because of pain, and difficulty returning to sleep after waking because of shoulder pain. Participants will answer the items based on their experience during the previous seven days. The number and wording of the items may be revised after expert panel review and pilot testing.\n\nThe development process will have three stages. First, the draft items will be reviewed by a multidisciplinary panel of 20 experts, including specialists in physical medicine and rehabilitation, orthopedics and traumatology, algology, and psychiatry. The experts will rate each item for clinical relevance, clarity, and ability to represent night pain. Their ratings will be used to assess content validity and to revise or remove items when necessary.\n\nSecond, the revised module will be tested in a pilot group of approximately 20-30 participants. The pilot assessment will examine whether the items are easy to understand, how long the module takes to complete, whether any items are frequently left unanswered, and whether responses are concentrated at the lowest or highest possible scores. The pilot data will not be included in the main psychometric analyses. Necessary changes will be made before the final version is used in the main study.\n\nThird, the final version of the Night Pain Module will be evaluated in the main study sample. Its structure will be examined using exploratory and confirmatory factor analyses. These analyses will assess whether the items measure one general night pain concept or separate features, such as sleep-disturbing pain and position-related pain. Internal consistency and item-total relationships will also be evaluated.\n\nApproximately 60 clinically stable participants who do not receive treatment for their shoulder during the interval will complete the module again after 7-10 days. These data will be used to assess test-retest reliability.\n\nThe clinical validity of the module will be evaluated by examining its relationships with the Pittsburgh Sleep Quality Index, the Shoulder Pain and Disability Index, daytime shoulder pain intensity, and the Pain Catastrophizing Scale. Module scores will also be compared between participants with better and poorer sleep quality. These analyses will show whether the module reflects the expected relationships between night pain, sleep, shoulder function, daytime pain, and pain-related thoughts. The study is observational and does not include treatment assignment or an invasive procedure.","The study population will consist of adults aged 18-60 years with rotator cuff-related shoulder pain attending the physical medicine and rehabilitation outpatient clinics of the participating hospitals. Eligible participants will have anterolateral shoulder pain lasting at least six weeks and at least two positive shoulder provocation tests. Both female and male participants will be included. The study will not include healthy controls.",[31],{"label":32,"type":24,"description":33,"interventionNames":24},"Adults With Rotator Cuff-Related Shoulder Pain","Adults aged 18-60 years with shoulder pain lasting at least six weeks and a clinical diagnosis of rotator cuff-related shoulder pain. The diagnosis will be based on anterolateral shoulder pain and at least two positive clinical provocation tests. The study includes a single patient cohort without a healthy control group or an assigned intervention.",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Taha Yasin YILDIRIM, M.D.","CONTACT","+90 534 220 77 17","tyasinyildirim.ftr@gmail.com",{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},"Eser Kalaoğlu, M.D.","+90 536 814 14 99","eserkalaoglu@gmail.com",[45,59,70],{"facility":46,"status":24,"city":47,"state":24,"zip":48,"country":49,"countryCode":24,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Istanbul Physical Medicine and Rehabilitation Training and Research Hospital","Istanbul","34186","Turkey (Türkiye)",{"type":51,"coordinates":52},"Point",[53,54],28.94966,41.01384,{"lat":54,"lon":53},[57],{"name":41,"role":37,"phone":42,"phoneExt":24,"email":58},"eserkalaoglu@hotmail.com",{"facility":60,"status":24,"city":47,"state":24,"zip":61,"country":49,"countryCode":24,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Beylikduzu State Hospital","34500",{"type":51,"coordinates":63},[53,54],{"lat":54,"lon":53},[66],{"name":67,"role":37,"phone":68,"phoneExt":24,"email":69},"Sıddik Altuğ Yücel, M.D.","+90 537 457 46 74","altugyücel6@gmail.com",{"facility":71,"status":24,"city":72,"state":24,"zip":73,"country":49,"countryCode":24,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Mardin Training and Research Hospital","Mardin","47100",{"type":51,"coordinates":75},[76,77],40.74357,37.31309,{"lat":77,"lon":76},[80],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Eser Kalaoglu","Associate Professor of Physical Medicine and Rehabilitation",[86,88],{"name":71,"class":87},"UNKNOWN",{"name":60,"class":89},"OTHER","100657433","night-pain-module-for-rotator-cuff-related-shoulder-pain-100657433",false,"NCT07838233","Night Pain Module for Rotator Cuff-Related Shoulder Pain","Development and Psychometric Evaluation of a Night Pain Module in Rotator Cuff-Related Shoulder Pain","nclusion Criteria:\n\n* Age between 18 and 60 years\n* Shoulder pain lasting for at least six weeks\n* Anterolateral shoulder pain\n* Clinical diagnosis of rotator cuff-related shoulder pain based on at least two positive results among the following tests:\n\nNeer test Hawkins-Kennedy test Jobe (Empty Can) test Painful Arc test Resisted External Rotation test\n\n-Willingness to participate and ability to provide written informed consent\n\nExclusion Criteria:\n\n* Clinically evident frozen shoulder with restricted passive external rotation\n* Shoulder injection within the previous four weeks\n* Cervical radiculopathy\n* Acute shoulder trauma\n* Marked muscle weakness suggesting a full-thickness rotator cuff tear\n* Calcific tendinitis\n* Neurological or systemic disease that prevents participation\n* Pregnancy, postpartum period, or breastfeeding\n* Inability to provide informed consent","ALL","18 Years","60 Years",{"count":101,"type":102},275,"ESTIMATED","OBSERVATIONAL","Night pain is common in people with rotator cuff-related shoulder pain and may disturb sleep and daily life. It may include difficulty falling asleep, waking because of pain, increased pain during the night, difficulty returning to sleep, and pain when lying on the affected shoulder. However, night pain is often assessed with only one pain score or a yes\u002Fno question.\n\nThis study aims to develop and evaluate a short Night Pain Module for people with rotator cuff-related shoulder pain. The current draft contains eight items assessing different features of night pain during the previous seven days. The items may be revised after expert review and pilot testing. The validity and reliability of the final version will be examined in the main study. A subgroup of participants will complete the module again after 7-10 days. No treatment or experimental procedure will be given as part of the study.",[106,107],"Shoulder Pain","Rotator Cuff Related Shoulder Pain",[109,110,111,112,113],"Night pain","Sleep quality","Validity and reliability","scale devolopment","rotator cuff syndrome","NOT_YET_RECRUITING","2026-09-17",{"date":117,"type":118},"2026-09-24","ACTUAL",{"date":120,"type":102},"2026-10-01",{"date":122,"type":102},"2027-10-01",{"name":5,"class":6},3]