Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT01346202
Status:
COMPLETED
Last Update Posted:
2013-07-15
First Post:
2011-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-12', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intensity of pain', 'timeFrame': 'Change from Baseline in intensity of pain at 1 year', 'description': 'pain intensity 1 year after multi-modale therapy compared with pain intensity before treatment'}], 'secondaryOutcomes': [{'measure': 'pain disability index', 'timeFrame': 'Change from Baseline in pain disability index at 6 months', 'description': 'pain disability index 6 month after multi-modale therapy compared with pain disability index before treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multi-modal pain therapy, chronic pain'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanktgeorg.de', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Complex and chronified pain syndromes requires a specialized therapeutic concept. From patients with chronic low back pain the investigators know, that an interdisciplinary multi-modal approach may improve the therapeutic success. In this observational study the investigators investigated if the multi-modal pain therapy is also effective in patients with mixed chronic pain syndromes.', 'detailedDescription': 'The multi-modal pain therapy includes:\n\n* specific drug therapy\n* pain education\n* psychological therapy\n* physical therapy\n* behavioral therapy\n* work hardening\n* bio-feedback\n* ergotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '260 consecutive patients with chronic pain syndromes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 18 years and \\<= 65 years\n* verified chronic pain for more than 6 month\n\nExclusion Criteria:\n\n* application for a pension\n* non-accordance with multi-modal pain therapy\n* dominant geriatric symptoms\n* dominant psychiatric symptoms'}, 'identificationModule': {'nctId': 'NCT01346202', 'acronym': 'IMPERApain', 'briefTitle': 'Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum St. Georg gGmbH'}, 'officialTitle': 'Influence of a Multimodal Day-unit Pain Therapy on Pain Experience, Pain-related Disability and Depression in Patients With Chronic Pain Syndromes', 'orgStudyIdInfo': {'id': 'EK-BR-28/10-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic pain', 'description': '260 consecutive patients with verified chronic pain syndromes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04129', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Klinikum St. Georg, Pain Center', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Armin R Sablotzki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum St. Georg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum St. Georg gGmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Armin Sablotzki, MD', 'investigatorAffiliation': 'Klinikum St. Georg gGmbH'}}}}