Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-03 @ 8:43 PM
Study NCT ID:
NCT02777450
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2016-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2016-05-05', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity Visual analogue scale', 'timeFrame': 'baseline before the block'}, {'measure': 'Change of the Pain intensity one hour after the block', 'timeFrame': 'one hour after the block'}, {'measure': 'Change of the pain intensity one month after the block', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the pain intensity six months after the block', 'timeFrame': 'six months after the block'}], 'secondaryOutcomes': [{'measure': 'range of motion ROM', 'timeFrame': 'baseline before the block', 'description': 'Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades'}, {'measure': 'Change of the range of motion ROM', 'timeFrame': 'one month after the block', 'description': 'Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades'}, {'measure': 'Change of the range of motion ROM', 'timeFrame': 'six months after the block', 'description': 'Measure of the pain free lumbar flexion and extension range of motion. Measured with single inclinometer in grades'}, {'measure': 'lumbar segmental provocation manual test', 'timeFrame': 'baseline before the block'}, {'measure': 'Change of the lumbar segmental provocation manual test', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the lumbar segmental provocation manual test', 'timeFrame': 'six months after the block'}, {'measure': 'lumbar manual segmental joint play test', 'timeFrame': 'baseline before the block'}, {'measure': 'Change of the lumbar manual segmental joint play test', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the lumbar manual segmental joint play test', 'timeFrame': 'six months after the block'}, {'measure': 'Algometer: Pressure Pain threshold', 'timeFrame': 'baseline before the block', 'description': 'Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5'}, {'measure': 'Change of the Algometer: Pressure Pain threshold', 'timeFrame': 'one month after the block', 'description': 'Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5'}, {'measure': 'Change of the Algometer: Pressure Pain threshold', 'timeFrame': 'six months after the block', 'description': 'Measure of the pressure pain threshold of the hand and the interspinous ligament from T12 to L5'}, {'measure': 'oswestry disability index', 'timeFrame': 'baseline before the block'}, {'measure': 'Change of the oswestry disability index', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the oswestry disability index', 'timeFrame': 'six months after the block'}, {'measure': 'hospital anxiety and depression scale', 'timeFrame': 'baseline before the block'}, {'measure': 'Change of the hospital anxiety and depression scale', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the hospital anxiety and depression scale', 'timeFrame': 'six months after the block'}, {'measure': '11 point global rating of change scale', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the 11 point global rating of change scale', 'timeFrame': '6 months after the block'}, {'measure': 'Douleur Neuropathique 4 questionnaire', 'timeFrame': 'baseline before the block'}, {'measure': 'Change of the Douleur Neuropathique 4 questionnaire', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the Douleur Neuropathique 4 questionnaire', 'timeFrame': 'six months after the block'}, {'measure': 'slump neural test', 'timeFrame': 'baseline before the block'}, {'measure': 'Change of the slump neural test', 'timeFrame': 'one month after the block'}, {'measure': 'Change of the slump neural test', 'timeFrame': 'six months after the block'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low back pain', 'physical examination', 'local anesthesia'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study evaluates the predictor value of manual test in lumbar chronic patients blocks. Bibliography has show limited evidence of clinical predictors in lumbar blocks. Prior to lumbar facet block or medial branch denervation patient will be evaluated with manual provocative segmental movements, lumbar sagittal range of motion, manual segmental movement and slump neural test . Immediate, one and six months effect will be registered.', 'detailedDescription': 'Clinical tests have sown limit evidence to predict efficacy of lumbar facet blocks. Segmental mobility tests have been included into the protocol to evaluate the efficacy of the lumbar blocks.\n\nChronic low back pain patients will be tested to evaluate the predictor value of manual clinical tests.\n\nPatients from the "Lozano Blesa" Hospital pain clinic will be evaluate before, one month and six months after the lumbar facet block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic lumbar pain patients from the pain clinic service of the Lozano Blesa University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 3 months of low back pain.\n* lumbar with or without leg pain.\n* patient treated with a lumbar facet block or medial nerve denervation.\n* capable to be physically explored.\n* capable to fill a questionaire.\n\nExclusion Criteria:\n\n* no mechanical pain.\n* severe medical condition.\n* severe lumbar trauma.\n* severe lumbar instability.\n* severe lumbar deformity\n* psychiatric disorder.'}, 'identificationModule': {'nctId': 'NCT02777450', 'briefTitle': 'Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Validity and Predictive Value of Manual Clinical Test to Identify Symptomatic Segments in Lumbar Chronic Patients', 'orgStudyIdInfo': {'id': 'PI16/0015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Block group', 'description': 'Lumbar facet block. Levobupivacaine 0,25% and corticosteroids', 'interventionNames': ['Procedure: lumbar facet block']}], 'interventions': [{'name': 'lumbar facet block', 'type': 'PROCEDURE', 'description': 'injection of Levobupivacaine 0,25% and corticosteroids', 'armGroupLabels': ['Block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Universidad de Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Elena Estébanez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Zaragoza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Yes to the pain clinic service'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Unidad de Investigación de Fisioterapia', 'investigatorFullName': 'santos caudevilla polo', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}