Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02361359
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2015-02-06', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '1 year postoperatively'}], 'secondaryOutcomes': [{'measure': 'Functional score', 'timeFrame': '1 year postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthroplasty'], 'conditions': ['Osteoarthritis', 'Chronic Pain', 'Catastrophization']}, 'referencesModule': {'references': [{'pmid': '35999466', 'type': 'DERIVED', 'citation': 'Hardy A, Sandiford MH, Menigaux C, Bauer T, Klouche S, Hardy P. Pain catastrophizing and pre-operative psychological state are predictive of chronic pain after joint arthroplasty of the hip, knee or shoulder: results of a prospective, comparative study at one year follow-up. Int Orthop. 2022 Nov;46(11):2461-2469. doi: 10.1007/s00264-022-05542-7. Epub 2022 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. We therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo joint arthroplasty (shoulder, hip ou knee) for osteoarthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* joint arthgroplasty (shoulder, hip ou knee)\n* osteoarthritis\n\nExclusion Criteria:\n\n* previous surgery in the same joint'}, 'identificationModule': {'nctId': 'NCT02361359', 'briefTitle': 'Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Ambroise Paré Paris'}, 'officialTitle': 'Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'APR012014'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Psychological questionnaires', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92000', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hospital Ambroise Paré Paris', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Ambroise Paré Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician responsible of clinical research', 'investigatorFullName': 'Shahnaz Klouche, MD', 'investigatorAffiliation': 'Hospital Ambroise Paré Paris'}}}}