Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-31 @ 12:19 AM
Study NCT ID:
NCT00440856
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2007-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presentation of Lumbar Disc and Reduction of Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-08', 'studyFirstSubmitDate': '2007-02-23', 'studyFirstSubmitQcDate': '2007-02-26', 'lastUpdatePostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective experience of radiculopathic pain by the patient following surgery', 'timeFrame': '2-4 months'}], 'secondaryOutcomes': [{'measure': 'Subjective experience of low back pain by the patient following surgery', 'timeFrame': '2-4 months'}, {'measure': 'Subjective experience of lower limb motor weakness by the patient following surgery', 'timeFrame': '2-4 months'}, {'measure': 'Subjective experience of paraesthesia by the patient following surgery', 'timeFrame': '2-4 months'}, {'measure': 'Maximum walking distance', 'timeFrame': '2-4 months'}, {'measure': 'Altered pattern of use of analgesia', 'timeFrame': '2-4 months'}, {'measure': 'Subjective experience of numbness by the patient following surgery', 'timeFrame': '2-4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intervertebral disc', 'Lumbar discectomy', 'Outcome', 'Radiculopathy due to prolapsed intervertebral disc.'], 'conditions': ['Radiculopathy']}, 'descriptionModule': {'briefSummary': 'The trial aims to assess the hypothesis that presentation of the disc material to the patient following a lumbar microdiscectomy would positively influence the improvement in their leg and back symptoms.', 'detailedDescription': 'Objective. The trial aims to assess the hypothesis that presentation of removed material to the patient following a lumbar microdiscectomy would positively influence the improvement in their radiculopathic and degenerative symptoms.\n\nDesign. Data will be collected prospectively. Patient allocation to treatment groups will be by simple randomization using a computer generated sequence of random numbers. Trial participants will be blinded as to the trial hypothesis and investigators blinded to patient allocation.\n\nSetting. Patients will all be treated in a single secondary care unit.\n\nParticipants. All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc over a six month period will be considered for entry into the trial. Exclusion criteria: inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.\n\nIntervention. Patients allocated to the experimental arm will be given the removed disc fragments to keep once they have recovered from anaesthesia. Those in the control arm will not be shown disc fragments (best available treatment).\n\nMain outcome measure. The degree of improvement in radiculopathic and degenerative symptoms reported by the patient at 2-3 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc\n\nExclusion Criteria:\n\n* inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.'}, 'identificationModule': {'nctId': 'NCT00440856', 'acronym': 'POLDAROS', 'briefTitle': 'Presentation of Lumbar Disc and Reduction of Symptoms', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Reduction in Leg and Back Pain Following Lumbar Microdiscetomy in Those Shown the Removed Disc Fragments After the Operation: a Double Blind Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'DT2656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'Participants are given their disc fragments following their operation', 'interventionNames': ['Behavioral: Presentation of excised intervertebral disc fragments']}], 'interventions': [{'name': 'Presentation of excised intervertebral disc fragments', 'type': 'BEHAVIORAL', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0RE', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': "St George's Hospital, University of London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Marios C Papadopoulos, DLitt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St George's, University of London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}