Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT05713604
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"MecPain", a New Questionnaire to Assess Chronic Pain Mechanisms.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D000098653', 'term': 'Nociplastic Pain'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The scores of the various components of the 'MecPain' questionnaire", 'timeFrame': 'Six months', 'description': "A score will be assigned based on the answers to each of the 12 questions of the 'MecPain' questionnaire"}], 'secondaryOutcomes': [{'measure': "The scores of the'DN4' and 'PainDETECT' questionnaires", 'timeFrame': 'Six months', 'description': 'Scores of the\'DN4" ranging from 0 to 10 and scores \'PainDETECT\' ranging from 0 to 38'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathic pain', 'Nociplastic pain', 'Nociceptive pain', 'Chronic pain mechanisms'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': "Validation of a new clinical questionnaire, called 'MecPain', including 12 questions, aimed at better defining the pathophysiological mechanisms of a chronic pain condition. This questionnaire includes 8 components/sub-components, reflecting various aspects of the 3 main mechanisms of chronic pain: nociceptive, neuropathic, nociplastic. A series of 240 patients with well-characterized chronic pain syndrome (for more than 6 months) of the nociceptive, neuropathic or nociplastic type will be recruited (80 patients per type of pain). The patients will be interviewed by a pain specialist to complete the 12 questions of the questionnaire during a routine visit in a Pain Center (CHU Grenobles Alpes, Grenoble, France or CHU Henri Mondor, Creteil, France). The scoring obtained with the 'MecPain' questionnaire will be compared to the presence of neuropathic pain assessed by two previously validated questionnaires, the 'DN4' and the 'PainDETECT' questionnaires. The expected outcome is a validation of the 'MecPain' questionnaire to provide a better understanding of the pathophysiological mechanisms relating to the presence of a chronic pain syndrome in a given patient.", 'detailedDescription': 'The main objective of this study is to specify the physiopathological mechanisms of a chronic pain syndrome according to 5 main components (+ 3 "sensory" sub-components) reflecting various aspects of the 3 main mechanisms of chronic pain: nociceptive, neuropathic, nociplastic.\n\nA score will be assigned based on the answers to each of the 12 questions of the \'MecPain\' questionnaire for each of the 8 components/sub-components mentioned above.\n\n240 chronic pain patients will be included (in two centers), according to 3 categories: 80 patients with nociceptive pain (mechanical or inflammatory joint or spinal pain), 80 patients with neuropathic pain (painful peripheral neuropathy, neuralgia or radiculalgia, pain related with spinal cord or brain injury), and 80 patients with nociplastic pain (fibromyalgia, glossodynia, temporomandibular joint pain, irritable bowel syndrome, painful bladder syndrome).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic pain for more than 6 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of a chronic pain syndrome (pain for more than 6 months);\n* well-characterized pain syndrome of the nociceptive, neuropathic or nociplastic type\n\nExclusion Criteria:\n\n* Opposition to the use of data obtained in the context of standard clinical follow-up.'}, 'identificationModule': {'nctId': 'NCT05713604', 'acronym': 'MecPain', 'briefTitle': '"MecPain", a New Questionnaire to Assess Chronic Pain Mechanisms.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Validation of a New Clinical Questionnaire for the Evaluation of the Pathophysiological Mechanisms of Chronic Pain "MecPain".', 'orgStudyIdInfo': {'id': 'Grenoble University Hospital'}}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'HODAJ, HASAN', 'role': 'CONTACT', 'email': 'HHODAJ@chu-grenoble.fr'}], 'facility': 'CHU de GRENOBLE ALPES', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'LEFAUCHEUR, Jean Pascal', 'role': 'CONTACT'}], 'facility': 'Henri Mondor', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Hasan HODAJ, MD - PhD', 'role': 'CONTACT', 'email': 'hhodaj@chu-grenoble.fr', 'phone': '0476765213'}, {'name': 'Jean-Pascal LEFAUCHEUR, MD - PhD', 'role': 'CONTACT', 'email': 'jean-pascal.lefaucheur@aphp.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}