Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03491618
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective comparative study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-06', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAIN REDUCTION ON VAS/NRS', 'timeFrame': '1-3-6 months', 'description': 'Reduction in pain, at 1,3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'OSWESTRY DISABILITY INDEX', 'timeFrame': '1-3-6 months', 'description': 'Quantify disability for low back pain.'}, {'measure': 'ROLAND MORRIS', 'timeFrame': '1-3-6 months', 'description': 'Health status measure for low back pain'}, {'measure': 'MEDICATION REDUCTION', 'timeFrame': '1-3-6 months', 'description': 'Pain medication reduction'}, {'measure': 'WORKING STATUS', 'timeFrame': '1-3-6 months', 'description': 'CHANGE IN WORKING STATUS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumbar facet joint pain', 'Lumbar Medial Branch Neurotomy', 'Chronic Low Back Pain'], 'conditions': ['Lumbar Facet Joint Pain', 'Lumbar Medial Branch Neurotomy']}, 'descriptionModule': {'briefSummary': 'Prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation.', 'detailedDescription': 'Patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial branch denervation as treatment. Many types if canulae exist, and many types of placing them in relation to the Medial Branch nerves (MB). The EARL study tries to compare the analgesic effect of thin canulae (22 gauge) placed perpendicular to MB to thicker canulae (18 gauge) placed parallel to MB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low back pain of \\> 3 months\n* 18-80 years\n* VAS or NRS\\>6\n* Positive controlled block\n\nExclusion Criteria:\n\n* Pregnancy\n* Psichiatric disorders\n* Not being able to fulfil questionnaires\n* Body Mass Index\\>35\n* Labor Litigation\n* Negative or non conclusive controlled block\n* Failed Back Surgery Syndrome'}, 'identificationModule': {'nctId': 'NCT03491618', 'acronym': 'EARL', 'briefTitle': 'Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'Evaluación de la Analgesia a Corto y Medio Plazo de Las Diferentes Posiciones y Tipos de Las cánulas de Radiofrecuencia, en la denervación Del Ramo Medial Del Nervio Dorsal Lumbar', 'orgStudyIdInfo': {'id': 'HULP5017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PARALLEL', 'description': 'Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy.', 'interventionNames': ['Other: PAIN REDUCTION ON VAS/NRS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PERPENDICULAR', 'description': 'Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy.', 'interventionNames': ['Other: PAIN REDUCTION ON VAS/NRS']}], 'interventions': [{'name': 'PAIN REDUCTION ON VAS/NRS', 'type': 'OTHER', 'description': 'Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.', 'armGroupLabels': ['PARALLEL', 'PERPENDICULAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28029', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}