Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 3:56 PM
Study NCT ID:
NCT06893900
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Shoulder Pathways Involving the Cuff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Pain And Disability Index (SPADI)', 'timeFrame': '1 year', 'description': 'The SPADI is a patient reported outcome measure assessing pain and function in the shoulder.'}], 'secondaryOutcomes': [{'measure': 'Total number of different healthcare pathways and their description', 'timeFrame': '1 year', 'description': 'Number and nature of different healthcare pathways that patients go through after having had a first general practitioner consultation for a first or new episode of non-traumatic rotator cuff related shoulder pain. E.g. : "surgical pathway", rheumatology pathway", "conservative pathway".'}, {'measure': 'Number and proportion of patient in each healthcare pathway', 'timeFrame': '1 year', 'description': 'Number and proportion of patient in each healthcare pathway that patients go through after having had a first general practitioner consultation for a first or new episode of non-traumatic rotator cuff related shoulder pain.'}, {'measure': 'Delay for the first secondary care consultation', 'timeFrame': '1 year', 'description': 'Delay between the GP referall and the consultation with a physiotherapist or a surgeon.'}, {'measure': 'Number and nature of adverse event', 'timeFrame': '1 year', 'description': 'Number and nature of adverse event in each pathway'}, {'measure': 'Shoulder Pain And Disability Index (SPADI)', 'timeFrame': 'baseline, 2 weeks, 2, 4, 6 and 9 months', 'description': 'Pain and function shoulder PROM'}, {'measure': 'Pain Self-Efficacy Questionnaire-Fr', 'timeFrame': 'baseline, 6 and 12 months', 'description': 'PROM assessing pain self-efficacy'}, {'measure': 'Patient belief in the efficacy of rehabilitation', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Multiple choice question : "You believe that shoulder rehabilitation: \'allows for full recovery,\' \'allows for partial recovery,\' or \'does not allow for recovery.\'"'}, {'measure': 'Visual Analog Pain Scale', 'timeFrame': '1 year', 'description': 'Self administered pain assessment'}, {'measure': 'Tampa Scale of Kinesiophobia 11-item', 'timeFrame': 'Baseline and 6 and 12 months', 'description': 'PROM assessing kinesiophobia'}, {'measure': 'Fear and Avoidance Belief Questionnaire (FABQ)', 'timeFrame': 'baseline and 6 months', 'description': 'PROM assessing fear and avoidance beliefs'}, {'measure': 'EQ5D-5L', 'timeFrame': 'Baseline, 2, 4, 6, 9, 12 months', 'description': 'PROM assessing quality of life'}, {'measure': 'Direct costs', 'timeFrame': '2, 4, 6, 12 months', 'description': 'Healthcare ressource consumption (Patient healthcare provider consultations, imaging, prescribed drugs, surgeries).'}, {'measure': 'Indirect costs', 'timeFrame': '2, 4, 6 and 12 months', 'description': 'Sick leaves'}, {'measure': 'Referrals', 'timeFrame': '2, 4, 6, 9 and 12 months', 'description': 'Number and types of referrals to other healthcare professionals'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 year', 'description': 'Please respond to the statements below by circling the answer that best reflects your opinion regarding the care you received. (5 points likert scale for each item : Not at all satisfied - Not satisfied - Neutral - Satisfied - Completely satisfied and a Not Concerned option).\n\nThe dimensions assessed are :\n\n1. Respect for my values, preferences, and needs\n2. Coordination and integration of the care I received\n3. Information, communication, and education about my condition\n4. Physical comfort during care\n5. Emotional support, relief of my fears and anxiety\n6. Involvement of my family and close relatives in my care\n7. Transition and continuity of care\n8. Accessibility of care'}, {'measure': 'Patient preferences and motivation regarding a surgical or conservative pathway', 'timeFrame': 'baseline, 2, 4, 6, 9 and 12 months', 'description': 'Semi-guided interviews with patients from each identified pathway at different points in time.'}, {'measure': 'Dominant upper limb and involved upper limb', 'timeFrame': 'Baseline', 'description': 'Dominant upper limb: left, right, or neither Affected upper limb: left, right, or both'}, {'measure': 'Quick DASH', 'timeFrame': 'At baseline and 12 months', 'description': 'The sort version of the "disability of the arm, the shoulder and the hand" patient reported outcome measure.'}, {'measure': 'PASS', 'timeFrame': '12 months', 'description': 'Patient Acceptable Symptom State : "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" - Dichotomic answer.'}, {'measure': 'Anchor-based MCID', 'timeFrame': 'Baseline, 2, 4, 6, 9 and 12 months', 'description': 'Patients are asked : "Since the last questionnaire, my shoulder pain and function has :\n\n* Significantly improved\n* Improved, but not really changed\n* Neither improved nor deteriorated\n* Worsened, but not really changed\n* Significantly worsened"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rotator cuff', 'health economics', 'cost utility', 'incapacity', 'shoulder', 'non-traumatic'], 'conditions': ['Rotator Cuff Shoulder Syndrome and Allied Disorders', 'Rotator Cuff Related Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'New recommendations regarding care pathways for the management of shoulder pain syndromes have recently been published. We aim to analyze and compare the existing care pathways and identify the most appropriate approaches for different patient profiles.\n\nOur primary objective is to compare pain levels and shoulder function one year after your initial consultation with your general practitioner for this episode. We also seek to assess which healthcare professionals you consult for your shoulder management, the treatments you receive (e.g., analgesics), and any imaging studies you undergo (if prescribed).\n\nWe will send you notifications to remind you of the survey completion schedule and provide the link to access the questionnaire.\n\nParticipation in this study requires your commitment and adherence to the timeline, as missing data may compromise the analysis of results.\n\nNon-participation in the study will not affect your current medical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from the French general population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rotator cuff related shoulder pain\n* Consultation with a general practitionner for this disorder in the 6 weeks prior to the inclusion\n\nExclusion Criteria:\n\n* History of upper limb trauma associated with the current episode of shoulder pain\n* Neurologic or rheumatismal shoulder disorder\n* Frozen shoulder (current or past)\n* History of advanced glenohumeral athritis\n* History of shoulder surgery (on the affected side)'}, 'identificationModule': {'nctId': 'NCT06893900', 'acronym': 'ASPIC', 'briefTitle': 'Assessing Shoulder Pathways Involving the Cuff', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Description of Care Pathways in Non-Traumatic Rotator Cuff Related Shoulder Pain Syndrome', 'orgStudyIdInfo': {'id': '2024-A01019-38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary care non-traumatic shoulder pain', 'description': 'Patients will be enrolled if they receive care in France for non-traumatic shoulder disorder, that is related to the rotator cuff.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Thomas LATHIERE, PT, PhDc', 'role': 'CONTACT', 'email': 'thomas.lathiere@univ-grenoble-alpes.fr', 'phone': '+33457041225'}, {'name': 'Beatrice GENOUX, MSc', 'role': 'CONTACT', 'email': 'bgenoux@chu-grenoble.fr'}], 'overallOfficials': [{'name': 'Thomas LATHIERE, PT, PhDc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Alpes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': "Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK)", 'class': 'UNKNOWN'}, {'name': 'GIRCI Auvergne Rhône-Alpes', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}