Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04686435
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-17', 'size': 1892843, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-20T04:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with more than 41% improvement in disability 12 months after diagnosis as measured by Quick-DASH.', 'timeFrame': '12 months', 'description': 'Quick-DASH (Disabilities of the Arm, Shoulder and Hand) is a patient reported questionnaire measuring upper extremity function and pain.'}], 'secondaryOutcomes': [{'measure': 'Number of patients in the normal able-bodied population changing from "Being associated with the labour market" to "Not being associated with the labour market" in work participation classification.', 'timeFrame': '5 years', 'description': 'Registry obtained information about participants work affiliation from diagnosis to five years after inclusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Pain', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'In a longitudinal cohort project, the objective is to evaluate general prognostic and individual risk factors for long lasting shoulder pain, with a specific focus on evaluation of the association between metabolic syndrome and tendinopathy, while simultaneous adjusting for other potential prognostic candidate variables (PROGRESS Theme I-II).', 'detailedDescription': 'The VHS Cohort is a prospective cohort trial evaluating a wide range of patient reported and clinical prognostic factors, attained prior to initiation of treatment, among shoulder patients referred for diagnostic evaluation at the specialized shoulder unit at Vejle Hospital, Denmark. The department receives approximately 2000 new patients each year.\n\nPrior to medical examination, patients will be asked to fill in a baseline questionnaire, and from the electronic patient record, a range of different clinical factors will be obtained.\n\nSubsequently, patients will be asked to answer questionnaires on patient reported outcomes after 1, 3, 6, and 12 months. Five years after inclusion into the trial, work affiliation will be retrieved from registries in order to evaluate association between shoulder disorders and work affiliation.\n\nThe objective of the VHS Cohort Project is to evaluate general prognostic and individual risk factors for long lasting shoulder pain. A specific focus is evaluation of the association between metabolic syndrome and rotator cuff tendinopathy while simultaneously adjusting for other potential prognostic candidate variables (PROGRESS Theme I-II). In a subsequent cohort (VHS Cohort Project II), the objective will be to develop a prognostic model for the treatment effect of Rotator Cuff Related Shoulder Pain (RCRSP) (PROGRESS Theme III).\n\nVHS Cohort Project I:\n\nAim 1: Evaluate the risk of consistent pain one year after diagnosis among patients diagnosed with: RCRSP; Rotator cuff lesions (conservatively treated); Acromioclavicular osteoarthritis and Adhesive capsulitis (PROGRESS Theme I).\n\nAim 2: Evaluate the risk of consistent pain one year after surgery for: subacromial Decompression OR Rotator Cuff lesion (PROGRESS Theme I).\n\nAim 3: Evaluate the risk of consistent pain one year after diagnosis in patients with metabolic syndrome compared to patients without metabolic syndrome, with particular emphasis on patients diagnosed with RCRSP while simultaneously adjusting for other potential prognostic candidate variables (PROGRESS Theme II).\n\nWe hypothesize that\n\n* Significantly more patients with RCRSP have metabolic syndrome than patients diagnosed with other shoulder-specific diagnoses\n* Significantly more patients with metabolic syndrome and diagnosed with RCRSP are classified as non-responders to treatment than patients with other shoulder specific diagnoses 52 weeks after initial medical examination.\n* Significantly more shoulder patients with metabolic syndrome report multiple musculoskeletal pain sites than shoulder patients without metabolic syndrome at first medical examination.\n\nAim 4: From clinical examination findings and patient reported information identify the strongest individual predictors of prognostic value for persistent shoulder pain and disability one year after initial medical examination in patients with rotator cuff related pain syndrome (RCRSP) (Diagnostic codes: DM75.1; DM75.1A; DM75.1B; DM75.4; DM75.5; DM75.8; DM75.9) treated conservatively with either exercise, corticosteroid injection, or a combination of the two, while simultaneously adjusting for other potential prognostic candidate variables (PROGRESS Theme II).\n\nAim 5: From clinical examination findings and patient reported information identify the strongest individual preoperative predictors of prognostic value for persistent shoulder pain and disability one year after surgery for patients receiving SubAcromial Decompression (SAD) surgery (Procedure code: KNBH51), while simultaneous adjusting for other potential prognostic candidate variables (PROGRESS Theme II).\n\nAim 6: From clinical examination findings and patient reported information, identify the strongest individual predictors of five-year work participation rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort will include all patients diagnosed with a shoulder disorder at their medical examination, and have given written consent to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for medical examination to the shoulder sector, orthopedic Department, Vejle Hospital - Hospital Lillebaelt\n* Older than 18 years\n* Diagnosed with shoulder disorder at medical examination.\n\nExclusion Criteria:\n\n* Significant cognitive impairment or language issues\n* Symptomatic cervical spine pathology\n* Older than 75 years.'}, 'identificationModule': {'nctId': 'NCT04686435', 'briefTitle': 'Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis: The Prospective Vejle Hospital Shoulder Cohort (VHS Cohort) With Focus on Prognostic Factors', 'orgStudyIdInfo': {'id': 'VHS Cohort 20/12316'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-surgical treatment', 'description': 'Shoulder patients referred for non-surgical treatment after being diagnosed at the medical examination.', 'interventionNames': ['Other: Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupuncture']}, {'label': 'Surgical treatment', 'description': 'Shoulder patients referred for surgical treatment after being diagnosed at the medical examination.', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupuncture', 'type': 'OTHER', 'otherNames': ['Physiotherapy', 'Exercise', 'Corticosteroid injection', 'Medication', 'Acupuncture'], 'description': 'Treatment consisting of different non-surgical interventions as recommended by the orthopedic specialist and decided upon in shared decision making with the patient', 'armGroupLabels': ['Non-surgical treatment']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Surgery can consist of rotator cuff repair, Bankart repair, subacromial decompression, biceps tenodesis or tenotomy, acromioclavicular joint resection.', 'armGroupLabels': ['Surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'state': 'Region Syddanmark', 'country': 'Denmark', 'facility': 'Vejle Hospital, University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Kim G. Ingwersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vejle Hospital, University Hospital of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymized data will be shared upon direct contact to principal investigator with relevant purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'The A.P. Moller Foundation', 'class': 'UNKNOWN'}, {'name': 'The Lillebaelt Hospital Research Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}