Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05676060
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2022-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
X-ray Guided Facet Block in Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'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': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-22', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale', 'timeFrame': 'Baseline', 'description': "The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between paints with similar conditions. VAS has been widely used in diverse adult populations"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'Review outcome of injection of facet joint in chronic low back pain', 'detailedDescription': 'Low back pain is a common problem that most people may experience. the incidence of low back pain is highest in the third decade and increases with age until the 60-65 year age group.\n\nIn the USA the prevalence of Low back pain is between 15 and 45%. Facet joint is the primary cause of pain in 10-15% of young adult patients with chronic low back pain.\n\nProbable risk factors include genetic factors, age, smoking, heavy physical work, static work postures, lifting, vibration, obesity, and psychosocial factors.(2) Other Causes of low back pain include muscle and ligament strain, bulging or ruptured disc, arthritis, osteoporosis Treatment of chronic low back pain include pharmacological treatment, ,epidural steroid injection ,facet joint block and back surgery The facet joints are a set of plane types of synovial joints between the articular processes of two adjacent vertebrae, The lumbar facet joint is innervated by the medial branch from the posterior ramus of the lumbar spinal nerve.\n\nLumbar facet joint injections are performed by various techniques, including fluoroscopic-guided technique indications of diagnostic and therapeutic facet joint interventions\n\n1. Average pain levels \\> 5 on a scale of 0 to 10.\n2. Contraindications or inability to undergo physical therapy or inability to tolerate oral medications.\n\nComplications from facet joint injections in the lumbar spine are rare and mostly related to the needle placement and/or reactions to injected drugs.(3)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individual', 'eligibilityCriteria': 'Inclusion criteria:1-strong clinical suspicion of the facet syndrome,\n\n2-Focal tenderness over the facet joints\n\n3-Low back pain with normal radiological findings,\n\n4-Post-laminectomy syndrome with no evidence of arachnoiditis or recurrent disc disease,\n\n5-Persistent low back pain after lumbar spinal 6- Failed conservative treatment, including physical therapy with exercises, chiropractic management, and pharmacologic therapy\n\nExclusion Criteria:\n\n\\- 1- Low back pain with abnormal radiological findings,\n\n2-Post-laminectomy syndrome with evidence of arachnoiditis or recurrent disc disease,'}, 'identificationModule': {'nctId': 'NCT05676060', 'briefTitle': 'X-ray Guided Facet Block in Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'X-ray Guided Facet Block in Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'Facet block'}}, 'armsInterventionsModule': {'interventions': [{'name': 'quasi', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['facet block'], 'description': 'block facet joint in back pain due to afacet cause'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nada Tarek', 'role': 'CONTACT', 'email': 'nadatarek33332@gmail.com', 'phone': '01093906258'}, {'name': 'Mohamed Ragaee', 'role': 'CONTACT', 'phone': '01011777288'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Nada Tarek', 'investigatorAffiliation': 'Assiut University'}}}}