Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT01447160
Status:
UNKNOWN
Last Update Posted:
2011-10-06
First Post:
2011-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Facet Joint Infiltration in Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003348', 'term': 'Cortisone'}], 'ancestors': [{'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-05', 'studyFirstSubmitDate': '2011-07-29', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain visual analogic scale', 'timeFrame': 'baseline', 'description': 'pain visual scale graduated from zero to ten'}, {'measure': 'pain visual analogic scale', 'timeFrame': '4 weeks', 'description': 'pain visual analogic scale graduated 0--10'}, {'measure': 'pain visual analogic scale', 'timeFrame': '12 weeks', 'description': 'pain visual analogic scale graduated 0--10'}, {'measure': 'pain visual analogic scale', 'timeFrame': '24 weeks', 'description': 'pain visual analogic scale graduated 0--10'}], 'secondaryOutcomes': [{'measure': 'Rolland Morris questionnaire', 'timeFrame': 'baseline', 'description': 'assess functional capacity'}, {'measure': 'Rolland Morris questionnaire', 'timeFrame': '4 weeks', 'description': 'assess functional capacity'}, {'measure': 'Rolland Morris questionnaire', 'timeFrame': '12 weeks', 'description': 'assess functional capacity'}, {'measure': 'Rolland Morris questionnaire', 'timeFrame': '24 weeks', 'description': 'assess functional capacity'}, {'measure': 'SF-36 questionnaire', 'timeFrame': 'baseline', 'description': 'assess quality of life'}, {'measure': 'SF-36 questionnaire', 'timeFrame': '4 weeks', 'description': 'assess quality of life'}, {'measure': 'SF-36 questionnaire', 'timeFrame': '12 weeks', 'description': 'assess quality of life'}, {'measure': 'SF-36 questionnaire', 'timeFrame': '24 weeks', 'description': 'assess quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['facet joint', 'back pain', 'osteoarthritis', 'infiltration'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.', 'detailedDescription': 'Sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study.\n\nThey were randomized into experimental and control groups. The experimental group will be submitted to intra-articular infiltration of six facet joints. The control group will be submitted to intramuscular injection of six lumbar paravertebral points. After the randomization, all subjects will be assessed by an investigator blinded to the groups. The assessment will be taken just before the interventions (T0) and them 7 , 30 , 90 and 180 days after the interventions. The following assessment instruments will be used: pain visual analogical scale (VAS) (0-10cm), pain visual analogical scale during extension of the spine (VAS E) (0-10cm), Likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), Rolland-Morris questionnaire (0-24), short health survey questionnaire (SF36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (NSAIDs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* low back pain up to 3 months\n* pain on back extension\n* radiologic findings of facet joint osteoarthritis\n\nExclusion Criteria:\n\n* other causes of back pain\n* fibromyalgia\n* diabetes, arterial hypertension or glaucoma not well controlled\n* patients with contrast allergy'}, 'identificationModule': {'nctId': 'NCT01447160', 'briefTitle': 'Effectiveness of Facet Joint Infiltration in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of Facet Joint Infiltration in Low Back Pain', 'orgStudyIdInfo': {'id': 'FUSao Paulo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'facet joint infiltration', 'description': 'The experimental group will be submitted to intra-articular infiltration of six facet joints (L3/L4;L4/L5;L5/S1 bilaterally) with triamcinolone hexacetonide', 'interventionNames': ['Drug: Cortisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intramuscular injection', 'description': 'The control group which were submitted to triamcinolone acetonide intramuscular injection of six lumbar paravertebral points', 'interventionNames': ['Drug: Cortisone']}], 'interventions': [{'name': 'Cortisone', 'type': 'DRUG', 'description': 'intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide', 'armGroupLabels': ['facet joint infiltration', 'intramuscular injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023-062', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Luiza Ribeiro, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sao Paulo federal University', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'luiza ribeiro, doctor', 'role': 'CONTACT', 'email': 'luizahcr@hotmail.com', 'phone': '55-11 92678027'}], 'overallOfficials': [{'name': 'Luiza Ribeiro, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sao Paulo Federal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Federal University os Sao Paulo', 'oldOrganization': 'Federal University of São Paulo'}}}}