[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653925":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":48,"overallOfficials":54,"centralContacts":68,"locations":73,"responsibleParty":87,"collaborators":38,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":38,"studyType":103,"phases":38,"briefSummary":104,"conditions":105,"keywords":111,"overallStatus":119,"whyStopped":38,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Vejle Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with chronic Subacromial Pain Syndrome (SAPS) classified as having a nociplastic pain phenotype according to the IASP classification of nociplastic pain.","Grading system for nociplastic pain according to the International Association for the Study of Pain (IASP) classification of nociplastic pain (Kosek et al. 2021)","One time (baseline)",[14,17,21,24,27],{"measure":15,"description":16,"timeFrame":12},"Difference in shoulder function between nociplastic and non-nociplastic pain phenotypes as assessed by the QuickDASH questionnaire","QuickDASH is a self-reported questionnaire and it will be used to assess shoulder function. Scoring range from 0 (no disability) to 100 (most severe disability)",{"measure":18,"description":19,"timeFrame":20},"Difference in Kinesiophobia between nociplastic and non-nociplastic pain phenotypes as assessed by the Tampa Scale of Kinesiophobia (TSK) questionnaire.","TSK-13 is a self-reported scale and will be used to assess kinesiophobia. Scoring range from 13 to 53. A lower score indicates less kinesiophobia.","one time (baseline)",{"measure":22,"description":23,"timeFrame":20},"Difference in Self-efficacy between nociplastic and non-nociplastic pain phenotypes according to the Pain Self-Efficacy Questionnaire (PSEQ4)","PSEQ4 is a self-reported questionnaire and will be used to asses self-efficacy. Score range from 0 to 26. A lower score indicates less self-efficacy.",{"measure":25,"description":26,"timeFrame":12},"Difference in Overall health between nociplastic and non-nociplastic pain phenotype as assessed by the Health (WHO-5) questionnaire","WHO-5 is a self-reported questionnaire and will be used to assess the overall health. Score range from 0 to 100. A lower score indicates lower well-being.",{"measure":28,"description":29,"timeFrame":12},"Difference in Quality of life between nociplastic and non-nociplastic pain phenotype as assessed by the EQ-5D-5L questionnaire","EQ-5D-5L, EQ-VAS is a self-reported questionnaire and it will be used to asses quality of life. Range from 0-100. A lower score indicates lower quality of health.",[31,34],{"measure":32,"description":33,"timeFrame":12},"Explorative outcome: Change in Movement-Evoked Pain during Virtual reality (VR) between nociplastic and non-nociplastic pain phenotype as measured by the Visual Analog Scale (VAS)","A subsample of participants will complete VR-assessment. Movement evoked pain assesed during Virtual Reality tasks with manipulated visual feedback. Pain responses across VR conditions will be explored.\n\nPain during active shoulder elevation and pain at rest after active shoulder elevation will be measured on a VAS.",{"measure":35,"description":36,"timeFrame":12},"Explorative outcome: Change in degrees of shoulder movement during Virtual reality (VR) between nociplastic and non-nociplastic pain phenotype as measured by Range Of Movement (ROM) in degrees","A subsample of participants will complete VR-assessment. Range Of Movement (ROM) assesed during Virtual Reality tasks with manipulated visual feedback. ROM changes across VR conditions will be explored. Maximum ROM during a shoulder elevation task, and pain onset during shoulder elevation will be measured in degree.",{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":39,"timePerspective":40,"maskingInfo":38},null,"COHORT","CROSS_SECTIONAL","Musculoskeletal pain poses a significant burden on both individuals and society. The International Association for the Study of Pain (IASP) describes different pain mechanisms, including nociceptive, neuropathic and nociplastic pain. Identification of different pain mechanisms may be relevant for understanding pain presentation and treatment response in patients with musculoskeletal pain.\n\nShoulder pain ranks among the most prevalent musculoskeletal complaints with subacromial pain syndrome (SAPS) being the most prevalent diagnosis and a common diagnosis for non-traumatic shoulder pain. Exercise and other conservative treatments are considered first line treatment modalities in SAPS. However, a substantial proportion of patients experience limited or transient treatment effects and may develop chronic shoulder pain. This modest effect may be explained by a potential mismatch between the pain phenotype and the mechanistic assumptions underlying the treatment.\n\nThere are emerging clinical consensus statements for identifying primary pain phenotypes in musculoskeletal pain conditions. The IASP criteria for nociplastic pain offer a structured approach for classifying patients based on clinical features. However, the IASP criteria for identifying nociplastic pain have not, to our knowledge, been sufficiently investigated among patients with SAPS to elucidate the distribution of pain phenotypes in this population of patients with shoulder pain.\n\nMovement-evoked pain is a key feature in many patients with SAPS. Virtual Reality (VR) may provide a controlled enviroment in which visual feedback and percevied movement can be manipulated. Such manipulation may influence movement-evoked pain and could potentially provide additional information about pain responses associated with different pain phenotype. In this study, VR is therefore included as an exploratory assessment.\n\nThe primary aim of this cross-sectional study is to investigate the proportion and characteristics of patients diagnosed with SAPS who meet the IASP clinical criteria for nociplastic pain in an outpatient hospital setting.\n\nThe Primary objective is to estimate the prevalence of the nociplastic pain phenotype, according to the IASP classification, among patients with SAPS.\n\nThe exploratory objective is to investigate the relationship between movement- evoked pain responses during manipulated VR conditions and pain phenotype.\n\nThe exploratory hypothesis is that patients classified as having a nociplastic pain phenotype will demonstrate greater changes in pain intensity and movement-evoked pain responses during the VR conditions, compared with patients not classified as having a nociplastic pain phenotype.","Patients referred to and evaluated at the specialised shoulder clinic at Vejle Hospital, Denmark",[44],{"label":45,"type":38,"description":38,"interventionNames":46},"Patients diagnosed with SubAcromial Pain Syndrome (SAPS)",[47],"Procedure: Clinical evaluation",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":38},"PROCEDURE","Clinical evaluation","Participants undergo a standardised clinical assessment including medical history, specific orthopedic shoulder test, diagnostic ultrasound and x-ray of the shoulder.",[45],[55,59,62,65],{"name":56,"affiliation":57,"role":58},"Thomas Sørensen, PT, Cand.san","University of Southern Denmark","PRINCIPAL_INVESTIGATOR",{"name":60,"affiliation":57,"role":61},"Kim G Ingwersen, Pt, PhD","STUDY_DIRECTOR",{"name":63,"affiliation":57,"role":64},"Claus Varnum, Prof., PhD, MD","STUDY_CHAIR",{"name":66,"affiliation":67,"role":64},"Henrik B Vægter, Prof., PT, PhD","Odense University Hospital and University of Southern Denmark",[69],{"name":56,"role":70,"phone":71,"phoneExt":38,"email":72},"CONTACT","+4579409871","thomas.soerensen1@rsyd.dk",[74],{"facility":5,"status":38,"city":75,"state":38,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Vejle","7100","Denmark","DK",{"type":80,"coordinates":81},"Point",[82,83],9.5357,55.70927,{"lat":83,"lon":82},[86],{"name":56,"role":70,"phone":71,"phoneExt":38,"email":72},{"type":88,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100653925","nociplastic-pain-in-patients-diagnosed-with-subacromial-pain-syndrome-saps-100653925",false,"NCT07792434","Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)","Prevalence of Nociplastic Pain Phenotype in Patients Diagnosed With Subacromial Pain Syndrome (SAPS) - a Cross-sectional Study","The NAP SAPS","Inclusion Criteria:\n\n1. Diagnosed with SAPS (dm751, dm753, dm754, dm755\n2. Shoulder pain ≥ 3 months\n3. ≥ 3 out of 5 specific shoulder tests\n4. Age 18-70 years\n5. Increased pain during active arm elevation\n6. Pain during active elevation ≥ 3 (VAS)\n\nExclusion Criteria:\n\n1. Severe visual impairment\n2. Epilepsy\n3. Severe cognitive or physical impairment\n4. Language barrier (Danish)","ALL","18 Years","70 Years",{"count":101,"type":102},400,"ESTIMATED","OBSERVATIONAL","The goal of this cross-sectional study is to estimate the prevalence of the nociplastic pain phenotype, according to the IASP clinical criteria, among patients diagnosed with SubAcromial Pain Syndrome (SAPS).\n\nThe main question it aims to answer is: What is the prevalence of the nociplastic pain phenotype in patients diagnosed with SAPS in an outpatient clinic?\n\nPrimary outcome: Proportion of patients with SAPS meeting the IASP criteria for nociplastic pain.",[106,107,108,109,110],"Subacromial Pain Syndrome","Rotator Cuff Related Shoulder Pain","Shoulder Pain","Shoulder Impingement Syndrome","SAPS",[112,110,113,107,114,115,116,117,118],"Shoulder pain","Nociplastic pain","Virtual Reality","musculoskeletal pain","pain phenotype","central sensitivation","Chronic pain","NOT_YET_RECRUITING","2026-10-05",{"date":122,"type":123},"2026-10-06","ACTUAL",{"date":125,"type":102},"2026-10-19",{"date":127,"type":102},"2028-08",{"name":5,"class":6},1]