Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT03260361
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2017-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnosis and MEOPA in Regional Painful Syndrome Complex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'C576493', 'term': 'Meopa'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2017-01-24', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity measure using visual analogical ladder (EVA)', 'timeFrame': '3 weeks', 'description': 'pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson'}], 'secondaryOutcomes': [{'measure': 'QDSA ( Saint Antoine Pain Questions)', 'timeFrame': '3 weeks', 'description': 'description of the type of pain'}, {'measure': 'SF36 (Short Form (36) Health Survey)', 'timeFrame': '3 weeks', 'description': 'quality of life appreciation'}, {'measure': 'HADs', 'timeFrame': '3 weeks', 'description': 'Hospital Anxiety and Depression Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Algodystrophy of Hand']}, 'referencesModule': {'references': [{'pmid': '10524476', 'type': 'BACKGROUND', 'citation': 'Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010.'}]}, 'descriptionModule': {'briefSummary': 'Relation between hypnosis and MEOPA on algodystrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regional Painful Syndrome Complex\n\nExclusion Criteria:\n\n* deaf people'}, 'identificationModule': {'nctId': 'NCT03260361', 'acronym': 'ProHKM-SDRC', 'briefTitle': 'Hypnosis and MEOPA in Regional Painful Syndrome Complex', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex', 'orgStudyIdInfo': {'id': 'RC31/16/8235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis Kinesitherapy and MEOPA', 'description': 'combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)', 'interventionNames': ['Other: Hypnosis, kinesitherapy, MEOPA']}, {'type': 'OTHER', 'label': 'usual practice', 'description': 'physiopathology and treatments', 'interventionNames': ['Other: Usual practice']}], 'interventions': [{'name': 'Hypnosis, kinesitherapy, MEOPA', 'type': 'OTHER', 'otherNames': ['Hypnosis Kinesitherapy and MEOPA (HKM)'], 'description': 'classical intervention', 'armGroupLabels': ['Hypnosis Kinesitherapy and MEOPA']}, {'name': 'Usual practice', 'type': 'OTHER', 'description': 'Usual practice with treatments and physio', 'armGroupLabels': ['usual practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31130', 'city': 'Quint-Fonsegrives', 'country': 'France', 'facility': 'Croix du Sud', 'geoPoint': {'lat': 43.5852, 'lon': 1.5272}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Martine QUINTARD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}