Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-07-22 @ 9:08 PM
Study NCT ID:
NCT03871192
Status:
UNKNOWN
Last Update Posted:
2019-03-15
First Post:
2019-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The patients and the evaluator don't know if the injection was performed inside the joint or around the nerve"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the patients are randomly assigned to intraarticular injection or nerve block'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-03-10', 'studyFirstSubmitQcDate': '2019-03-10', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (VAS score)', 'timeFrame': '1 year', 'description': 'score from no pain (0) to maximum pain (10)'}], 'secondaryOutcomes': [{'measure': 'Oswestry scale', 'timeFrame': '1 year', 'description': 'score from no disability(0) to maximum disability (10)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FACET JOINTS', 'FACET INJECTIONS', 'NERVE BLOCK'], 'conditions': ['Facet Joint Pain', 'Facet Syndrome of Lumbar Spine', 'Facet Joints; Degeneration']}, 'descriptionModule': {'briefSummary': 'In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.', 'detailedDescription': 'Facet joint pain is considered as a nonspecific cause of spinal pain with an estimated prevalence of 12-61% of the population. At present, there are no unanimous clinical criteria to achieve and accurate diagnosis and the imaging findings do not show a direct correlation with the clinical symptoms.\n\nFacet syndrome treatment is also controversial and, although most clinical guidelines recommend nerve block as a diagnostic test, followed by neurolysis as therapeutic technique, there are many detractors of this therapeutic sequence.\n\nThe confusion is even greater when considering the variability of specialists who perform these techniques, the variability of methods used ranging from blind injections to injections guided by ultrasound, fluoroscopy or CT, or the amount of medication injected.\n\nThe investigators have long experience in the percutaneous treatment of pain and in the use of different imaging techniques. Although the investigators objectives are multiple, the main one is to know if there are any difference in the outcome of the facet syndrome treated by intra-articular injections and the block of the medial branch of the dorsal branch of the spinal nerve.\n\nAlong with the collaboration of other specialists the investigators want to address secondary objectives such as the usefulness of ultrasound and fluoroscopy in the treatment of facet syndrome and its comparison with those performed under CT guidance that is considered as the standard technique for its greater precision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- Lumbar facet syndrome diagnosed by the referring specialist: Rehabilitation, Traumatology or Neurosurgery 2 -Mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation.\n\n3- failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months\n\nExclusion Criteria:\n\n1. Previous back surgery and other ablative treatments.\n2. Contraindication for the use of corticosteroid or local anesthetic.\n3. Uncontrolled acute or chronic medical illness.\n4. Pregnancy or lactation.\n5. Presence of inflammatory arthropathy or neuropathy.\n6. Wounds or skin lesions in the area.\n7. Diabetes mellitus.\n8. Psychiatric disorders\n9. Refusal to participate in the study.\n10. Demonstration by imaging techniques of other causes that could justify the symptomatology.'}, 'identificationModule': {'nctId': 'NCT03871192', 'briefTitle': 'Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Complejo Hospitalario Universitario de Granada'}, 'officialTitle': 'Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome', 'orgStudyIdInfo': {'id': '0607-N-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FACET JOINT UNDER CT GUIDANCE', 'description': 'Injection of the facet joint under computed tomography guidance', 'interventionNames': ['Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NERVE BLOCK UNDER CT GUIDANCE', 'description': 'Injection of the nerve under computed tomography guidance', 'interventionNames': ['Diagnostic Test: FACET JOINT UNDER CT GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'type': 'EXPERIMENTAL', 'label': 'FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'description': 'Injection of the facet joint under fluoroscopy guidance', 'interventionNames': ['Diagnostic Test: FACET JOINT UNDER CT GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'description': 'Injection of the nerve under ultrasound guidance', 'interventionNames': ['Diagnostic Test: FACET JOINT UNDER CT GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'type': 'EXPERIMENTAL', 'label': 'FACET JOINT UNDER ULTRASOUND GUIDANCE', 'description': 'Injection of the facet joint under ultrasound guidance', 'interventionNames': ['Diagnostic Test: FACET JOINT UNDER CT GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NERVE BLOCK UNDER ULTRASOUND GUIDANCE', 'description': 'Injection of the nerve under computed ultrasound guidance', 'interventionNames': ['Diagnostic Test: FACET JOINT UNDER CT GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE']}], 'interventions': [{'name': 'FACET JOINT UNDER CT GUIDANCE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['facet joint', 'ct guidance'], 'description': 'injection of triamcinolone in the facet joint under CT guidance', 'armGroupLabels': ['FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'FACET JOINT UNDER ULTRASOUND GUIDANCE', 'NERVE BLOCK UNDER CT GUIDANCE', 'NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'name': 'NERVE BLOCK UNDER CT GUIDANCE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['posterior ramus', 'ct guidance'], 'description': 'injection of triamcinolone around the dorsal ramus under CT guidance', 'armGroupLabels': ['FACET JOINT UNDER CT GUIDANCE', 'FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'FACET JOINT UNDER ULTRASOUND GUIDANCE', 'NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'name': 'FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['facet joint', 'fluoroscopy guidance'], 'description': 'injection of triamcinolone in the facet joint under fluoroscopy guidance', 'armGroupLabels': ['FACET JOINT UNDER CT GUIDANCE', 'FACET JOINT UNDER ULTRASOUND GUIDANCE', 'NERVE BLOCK UNDER CT GUIDANCE', 'NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'name': 'NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['posterior ramus', 'fluoroscopy guidance'], 'description': 'injection of triamcinolone around the dorsal ramus under fluoroscopy guidance', 'armGroupLabels': ['FACET JOINT UNDER CT GUIDANCE', 'FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'FACET JOINT UNDER ULTRASOUND GUIDANCE', 'NERVE BLOCK UNDER CT GUIDANCE', 'NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'name': 'FACET JOINT UNDER ULTRASOUND GUIDANCE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['facet joint', 'ultrasound guidance'], 'description': 'injection of triamcinolone in the facet joint under ultrasound guidance', 'armGroupLabels': ['FACET JOINT UNDER CT GUIDANCE', 'FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'NERVE BLOCK UNDER CT GUIDANCE', 'NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE', 'NERVE BLOCK UNDER ULTRASOUND GUIDANCE']}, {'name': 'NERVE BLOCK UNDER ULTRASOUND GUIDANCE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['dorsal ramus', 'ultrasound guidance'], 'description': 'injection of triamcinolone around the dorsal ramus under ultrasound guidance', 'armGroupLabels': ['FACET JOINT UNDER CT GUIDANCE', 'FACET JOINT UNDER FLUOROSCOPY GUIDANCE', 'FACET JOINT UNDER ULTRASOUND GUIDANCE', 'NERVE BLOCK UNDER CT GUIDANCE', 'NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18014', 'city': 'Granada', 'state': 'SPA', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'JUANA MARIA DE HARO CASTELLANO', 'role': 'CONTACT', 'email': 'juanam.haro.exts@juntadeandalucia.es', 'phone': '+34958 020124'}, {'name': 'JUAN MORALES ARCAS', 'role': 'CONTACT', 'email': 'juan.morales.sspa@juntadeandalucia.es', 'phone': '+34 958 023136'}, {'name': 'NICOLAS PRADOS OLLETA, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'FERNANDO RUIZ SANTIAGO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ALBERTO MARTINEZ MARTINEZ, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'JADE GARCIA ESPINOSA, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Complejo Hospitalario Universitario Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '1800314', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'JUANA MARIA DE HARO CASTELLANO', 'role': 'CONTACT', 'email': 'juanam.haro.exts@juntadeandalucia.es', 'phone': '+34958 020124'}, {'name': 'JUAN MORALES ARCA', 'role': 'CONTACT', 'email': 'juan.morales.sspa@juntadeandalucia.es', 'phone': '+34 958 023136'}], 'facility': 'Hospital Neuro-Traumatologia', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'ALBERTO MARTINEZ MARTINEZ, MD', 'role': 'CONTACT', 'email': 'rralbert.martinez@gmail.com', 'phone': '+34645558225'}, {'name': 'Ana María Del Valle Díaz De La Guardia, MD', 'role': 'CONTACT', 'email': 'anam.valle.sspa@juntadeandalucia.es', 'phone': '+34958895414'}], 'overallOfficials': [{'name': 'FERNANDO RUIZSANTIAGO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '1 to 2 years', 'ipdSharing': 'YES', 'description': 'our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Complejo Hospitalario Universitario de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, section chief musculoskeletal radiology', 'investigatorFullName': 'FERNANDO RUIZ SANTIAGO', 'investigatorAffiliation': 'Complejo Hospitalario Universitario de Granada'}}}}