Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-13 @ 3:38 AM
Study NCT ID:
NCT02402335
Status:
UNKNOWN
Last Update Posted:
2015-03-30
First Post:
2015-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Different Types of Backache in Groups of Patients With Different Diagnoses of Degenerative Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Backache objectified by the PainDETECT Questionnaire', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ache']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether there are relations between different types of pain in groups of patients with different diagnoses of degenerative diseases of the spinal column and their related surgeries.', 'detailedDescription': "In the context of this work the pain of different groups of patients should be examined by means of the painDetect Questionnaire, the Roland-Morris disability questionnaire, clinical examinations and different imaging procedures. Two groups of patients are compared with each other. Group one consists of patients with osteoporotic fractures of the vertebra. Group two is formed by patients with osteochondria , spinal disc herniation and nerval compression. Both groups of patients undergo surgery, as they are suffering from pain (e.g. kyphoplasty, nucleotomy, spondylodesis, decompression). In order to differentiate between chronic nociceptive pain and chronic neuropathic pain in these two groups the painDetect questionnaire is used. To examine the severity of disability in the patients' everyday life the Roland-Morris Disability questionnaire is used.\n\nThe included patients are examined and seen preoperative, postoperative before discharge from hospital, 6 weeks and 6 months after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the University Hospital of Bonn who are strongly suffering from backaches that cannot be treated anymore by conservative methods.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Backache because of degenerative diseases\n* Surgery is necessary\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02402335', 'briefTitle': 'Study of Different Types of Backache in Groups of Patients With Different Diagnoses of Degenerative Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Study of Different Types of Pains in Groups of Patients With Different Diagnoses of Degenerative Diseases and Their Related Surgeries', 'orgStudyIdInfo': {'id': 'UKBORTAB01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 Fracture of vertebra', 'description': 'Osteoporotic fracture of the vertebra'}, {'label': '2 Nerve Compression', 'description': 'Osteochondria, Spinal disc herniation, Nerve compression'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Adelina Boeddinghaus', 'role': 'CONTACT', 'email': 'adelinaboeddinghaus@gmx.de'}], 'facility': 'University Hospital of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'centralContacts': [{'name': 'Robert Pflugmacher, PD Dr med', 'role': 'CONTACT', 'email': 'robert.pflugmacher@ukb.uni-bonn.de'}], 'overallOfficials': [{'name': 'Robert Pflugmacher, PD Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bonn, Clinics of Orthopedics and Traumatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr med Robert Pflugmacher', 'investigatorFullName': 'Robert Pflugmacher', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}