Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT03487120
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2018-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Facet Joint Denervation in the Treatment of Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-07', 'studyFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual analog scale for pain (VAS)', 'timeFrame': 'change from baseline score at 24 weeks', 'description': '10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Modified Oswestry Disability score (ODI)', 'timeFrame': 'change from baseline score at 24 weeks', 'description': 'The ODI is divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale. The range of scores is 0 to a maximum of 60. The total score is multiplied by 2 and expressed as a percentage. A score of 0 to 20 points indicates minimal disability; 20 to 40 points, moderate disability; and 40 to 60 points, severe disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': "A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 19 or older\n* a diagnosis of spinal stenosis\n* having neurogenic claudication\n* complained of back pain for at least 3 months\n\nExclusion Criteria:\n\n* previous surgery on their spine,\n* fracture, systemic inflammatory disease,\n* malignancies or an infection affecting their spine'}, 'identificationModule': {'nctId': 'NCT03487120', 'briefTitle': 'Open Facet Joint Denervation in the Treatment of Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'NCTO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'lumbar laminectomy'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lumbar laminectomy with denervation of the facet joint', 'interventionNames': ['Procedure: facet joint denervation']}], 'interventions': [{'name': 'facet joint denervation', 'type': 'PROCEDURE', 'description': 'Bipolar electrocautery', 'armGroupLabels': ['lumbar laminectomy with denervation of the facet joint']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. David Yen', 'investigatorAffiliation': "Queen's University"}}}}