Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT03636802
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Prevalence of Painful Symptoms of the Musculoskeletal System After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numbers of patients with symptoms of the musculoskeletal system', 'timeFrame': '1 years', 'description': 'numbers of patients presenting symptoms of the musculoskeletal system during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema , interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.\n\nThe evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.\n\nFollowing transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations;\n\nPatients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.\n\nAmong the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency , prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).\n\nPain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.\n\nThe purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.\n\nThe main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.', 'detailedDescription': 'Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema (primary deficit or in the context of COPD), interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.\n\nThe evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.\n\nFollowing transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations.\n\nPatients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.\n\nAmong the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency, prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).\n\nPain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.\n\nThe purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.\n\nThe main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient registered on the lung transplant waiting list of the CHU de Marseille', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient over 18\n\n* Having agreed to no opposition\n* Registered on the lung transplant waiting list of the CHU de Marseille\n* Able to read, understand and complete the self-questionnaires of the study\n\nExclusion Criteria:\n\nPatient under 18 years\n\n* Patient refusing follow up until 12 months post transplant\n* Pregnant women, persons deprived of their liberty, persons under guardianship or trusteeship, persons in an emergency situation\n* Person not affiliated to a social security scheme or not entitled to'}, 'identificationModule': {'nctId': 'NCT03636802', 'briefTitle': 'Study of the Prevalence of Painful Symptoms of the Musculoskeletal System After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Study of the Prevalence, Nature and Contributing Factors of Painful Symptoms of the Musculoskeletal System After Lung Transplantation; Impact on Physical Activity and Quality of Life', 'orgStudyIdInfo': {'id': '2017-48'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EXPERIMENTAL GROUP', 'description': 'Patient with respiratory failure and on a lung transplant waiting list', 'interventionNames': ['Other: Questionnaire BPI']}], 'interventions': [{'name': 'Questionnaire BPI', 'type': 'OTHER', 'description': 'Brief Pain Inventory (BPI) This is a scale of self-assessment, the Concise Pain Questionnaire in French. For all adult patients For any type of pain This is to ask the patient to answer questions in order to learn about us characteristics of his pain (its intensity and its repercussions on the plane biopsychosocial).', 'armGroupLabels': ['EXPERIMENTAL GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'state': 'PACA', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'PHILIPPE GIOVANNETTI', 'role': 'CONTACT', 'email': 'Philippe.GIOVANNETTI@ap-hm.fr', 'phone': '+33 491366141'}], 'facility': 'Assistance Publique Des Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'PHILIPPE GIOVANnETTI', 'role': 'CONTACT', 'email': 'Philippe.GIOVANNETTI@ap-hm.fr', 'phone': '+33 491366141'}], 'overallOfficials': [{'name': 'EMILIE GARRIDO PRADALIE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}