Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-11 @ 10:16 PM
Study NCT ID:
NCT02148003
Status:
TERMINATED
Last Update Posted:
2024-03-19
First Post:
2014-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of the Temperature Used in Thermal Radiofrequency Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mekhain@ccf.org', 'phone': '216 444-9114', 'title': 'Nagy Mekhail, MD', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected from the end of procedure to the 1-year follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'RFA at 90 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nRFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RFA at 80 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nRFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Persistent Parethesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) Pain Score 30-day After Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RFA at 90 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nRFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.'}, {'id': 'OG001', 'title': 'RFA at 80 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nRFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '30.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days after the procedure', 'description': 'The primary outcome was the Visual Analog Scale (VAS) pain score at 30-day follow-up visit, which was collected by patients marking a position on a strip to indicate the intensity of their pain. The locations patients marked are translated into a score from 0-100, with 0 being no pain and 100 corresponding to the worst imaginable pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RFA at 90 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nRFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.'}, {'id': 'FG001', 'title': 'RFA at 80 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nRFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Failed inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Met exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RFA at 90 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nRFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.'}, {'id': 'BG001', 'title': 'RFA at 80 Degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nRFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius\n\nC-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'spread': '13', 'groupId': 'BG000'}, {'value': '61', 'spread': '14', 'groupId': 'BG001'}, {'value': '58', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race data was not collected..', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race data was not collected..'}, {'title': 'Body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'spread': '4', 'groupId': 'BG000'}, {'value': '28', 'spread': '4', 'groupId': 'BG001'}, {'value': '28', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking history', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Any use of tobacco before the procedure', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes history', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Any medical history of type II diabetes before the procedure', 'unitOfMeasure': 'Participants'}], 'populationDescription': '58 patients received RFA at 80°C and 59 patients received RFA at 90°C.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-15', 'size': 241657, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-09T11:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'whyStopped': 'Study terminated by Principal Investigator', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2014-04-22', 'resultsFirstSubmitDate': '2024-02-19', 'studyFirstSubmitQcDate': '2014-05-23', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-19', 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) Pain Score 30-day After Procedure', 'timeFrame': '30 days after the procedure', 'description': 'The primary outcome was the Visual Analog Scale (VAS) pain score at 30-day follow-up visit, which was collected by patients marking a position on a strip to indicate the intensity of their pain. The locations patients marked are translated into a score from 0-100, with 0 being no pain and 100 corresponding to the worst imaginable pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study will determine if lumbar facets medial branches RFA at 90 degrees Celsius provides more overall pain relief (i.e., percent of improvement), when compared to ablation at 80 degrees Celsius with no additional adverse events.', 'detailedDescription': 'Chronic lower back pain (CLBP) is a significant health care issue in the United States and the world. CLBP contributes to decreased quality of life, decreased function and increased utilization of health care resources. The causes of CLBP tend to be multi-factorial. Arthropathy of the lumbar facet joints is thought to be a common etiology (15-45%). Radiofrequency Ablation (RFA) of the medial branch nerve of the facet joint is a well-established treatment modality used to decrease facet joint pains. However, a wide range of temperature is being used (70-90 degrees Celsius). In addition, the optimal temperature that provides the best patient outcomes with the least side effects is not well established in the pain management literature.\n\nThis study will determine if lumbar facets medial branches RFA at 90 degrees Celsius provides more overall pain relief (i.e., percent of improvement), when compared to ablation at 80 degrees Celsius with no additional adverse events. Furthermore, ablation of the lumbar facets nerve supply at 90 degrees Celsius will provide better improvement in the functionality level, general mood and quality of life as measured by VAS ( Visual Analog Scale) pain score, Pain Disability Index (PDI), McGill Pain questioner scores and Beck Inventory (BI) scores as those receiving the ablation at 80 degrees Celsius. Also, it is associated with less opioid consumption, no additional unwanted adverse events and/or complications along with less need to repeat RFA procedure over one year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years-old\n* Subjects who are able to give informed consent and to understand and comply with study requirements.\n* Predominantly axial low back pain ≥ 3 months in duration with no radicular pain below the knee that failed to conservative therapy.\n* Subjects who have chronic back pain attributed to lumbar facet joints arthropathy based on clinical evaluation (paraspinal tenderness and/or facet loading test in the absence of signs and symptoms suggestive of focal neurological deficits).\n* No history of previous back surgery at the intended treatment levels.\n* Adequate response to the diagnostic blocks without the use of steroids at the same levels of the intended block (Defined as ≥ 75% pain relief).\n* Patients who will undergo RFA of 3-4 lumbar facet medial branches on one side only.\n\nExclusion Criteria:\n\n* Subjects who decline to provide written consent or follow-up.\n* Subjects who have a history of adverse reactions to local anesthetic.\n* Subjects who are pregnant.\n* Subjects with bleeding disorders or active anticoagulation that cannot be stopped for few days close to the time of the procedure.\n* Subjects who have an active systemic or local infection.\n* Presence of radicular pain below the knee.\n* Patients who have other specific etiology of low back pain (e.g. significant spinal canal stenosis or grade 2 or 3 spondylolisthesis).\n* Secondary gain (i.e., ongoing litigation, worker's compensation or other financial incentives)\n* Psychopathology including depression, somatization or poor coping skills\n* Physical factors including non-sedentary lifestyle, e.g.; morbid obesity (BMI \\> 35kg/m2).\n* History of previous RFA at the same level(s) in the previous 12 months."}, 'identificationModule': {'nctId': 'NCT02148003', 'briefTitle': 'Effect of the Temperature Used in Thermal Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Effect of the Temperature Used in Thermal Radiofrequency Ablation on Outcomes of Lumbar Facets Medial Branches Denervation Procedures: A Randomized Double-Blinded Trial', 'orgStudyIdInfo': {'id': '13-1470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RFA at 90 degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius', 'interventionNames': ['Procedure: RFA at 90 degrees Celsius', 'Device: C-arm guided 20-gauge radiofrequency needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RFA at 80 degrees Celsius', 'description': 'Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius', 'interventionNames': ['Procedure: RFA at 80 degrees Celsius', 'Device: C-arm guided 20-gauge radiofrequency needle']}], 'interventions': [{'name': 'RFA at 90 degrees Celsius', 'type': 'PROCEDURE', 'description': 'Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius', 'armGroupLabels': ['RFA at 90 degrees Celsius']}, {'name': 'RFA at 80 degrees Celsius', 'type': 'PROCEDURE', 'description': 'Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius', 'armGroupLabels': ['RFA at 80 degrees Celsius']}, {'name': 'C-arm guided 20-gauge radiofrequency needle', 'type': 'DEVICE', 'description': 'Needles will be adjusted to optimize sensory and motor stimulation.', 'armGroupLabels': ['RFA at 80 degrees Celsius', 'RFA at 90 degrees Celsius']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Nagy Mekhail, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}