Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 12:29 PM
Study NCT ID:
NCT05000658
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Soluble Dexamethasone in Refractory Sciatica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012585', 'term': 'Sciatica'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness assessed by classical global algo-functional index: OSWESTRY', 'timeFrame': 'Week 3'}], 'secondaryOutcomes': [{'measure': 'Value of Eva scale for evaluated effectiveness on lower back pain', 'timeFrame': 'Month 6'}, {'measure': 'Value of Eva scale for evaluated effectiveness on lower back pain', 'timeFrame': 'Week 1'}, {'measure': 'Value of Eva scale for evaluated effectiveness on lower back pain', 'timeFrame': 'Week 3'}, {'measure': 'Value of Eva scale for evaluated effectiveness on lower back pain', 'timeFrame': 'Week 6'}, {'measure': 'Value of Eva scale for evaluated effectiveness on lower back pain', 'timeFrame': 'Month 3'}, {'measure': 'Value of Eva scale for evaluated effectiveness on sciatic pain', 'timeFrame': 'Week 1'}, {'measure': 'Value of Eva scale for evaluated effectiveness on sciatic pain', 'timeFrame': 'Week 3'}, {'measure': 'Value of Eva scale for evaluated effectiveness on sciatic pain', 'timeFrame': 'Week 6'}, {'measure': 'Value of Eva scale for evaluated effectiveness on sciatic pain', 'timeFrame': 'Month 6'}, {'measure': 'Number of days off work', 'timeFrame': 'Month 6'}, {'measure': 'Value of score to scale Oswestry', 'timeFrame': 'Month 6'}, {'measure': 'Value of score to scale Oswestry', 'timeFrame': 'Week 1'}, {'measure': 'Value of score to scale Oswestry', 'timeFrame': 'Week 6'}, {'measure': 'Value of score to scale Oswestry', 'timeFrame': 'Month 3'}, {'measure': 'Value of score to SF36 self questionnaires', 'timeFrame': 'Month 6'}, {'measure': 'Value of score to SF36 self questionnaires', 'timeFrame': 'Week 1'}, {'measure': 'Value of score to SF36 self questionnaires', 'timeFrame': 'Week 3'}, {'measure': 'Value of score to SF36 self questionnaires', 'timeFrame': 'Week 6'}, {'measure': 'Value of score to SF36 self questionnaires', 'timeFrame': 'Month 3'}, {'measure': 'Percentage of second injections required', 'timeFrame': 'Month 6'}, {'measure': 'Number of patients undergoing secondary surgery', 'timeFrame': 'Month 6'}, {'measure': 'Result of Clinical parameters', 'timeFrame': 'week 3'}, {'measure': 'Result of Imaging parameters', 'timeFrame': 'week 3'}, {'measure': 'Number of secondary effects', 'timeFrame': 'Month 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reluctant Sciatica, Infiltrations, Soluble Dexamethasone'], 'conditions': ['Sciatica']}, 'descriptionModule': {'briefSummary': 'This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable sciatica', 'detailedDescription': 'Injection of 4ml of Dexamethasone Phosphate Soluble or 4ml of saline solution depending on the randomisation arm'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with sciatica of disc origin (radio-clinical concordance on MRI or CT) postero-lateral\n* Duration of evolution greater than 3 weeks despite analgesic / AINS treatment, and less than 3 months\n* EVA sciatica pain \\> 4/10\n* Oswestry 30 at inclusion\n* Patient aged 18 years and older\n* Patient affiliated to a social security scheme\n* Patient able to understand the protocol and having signed an informed consent\n* Patient with an indication for corticosteroid infiltration in the context of their pathology\n\nCriteria for non-inclusion\n\n* Signs or risks of infection, in particular signs of virosis\n* Poor local skin condition\n* Anticoagulation with VKA or anti-Xa, or haemorrhagic disease\n* Neurological deficit \\< 3/5 or signs of cauda equina irritation\n* Tarlov's cyst or low dural sac below week 4\n* Hypersensitivity to Lidocaine, Dexamethasone, or any of its excipients\n* Infiltration of the spine within the previous 3 months\n* Patient with bilateral sciatica\n* Patient with sciatica of osteoarthritic origin\n* Patients with chronic respiratory insufficiency\n* Pregnant or breastfeeding women or women refusing effective contraception until M3\n* Patient deprived of liberty or under legal protection (guardianship or curatorship)\n* Patient under court protection\n* Patients participating in another clinical research protocol involving a drug or medical device\n* Patients unable to follow the protocol, as judged by the investigator\n* Patient refusing to participate in the study\n* Patient with clinically narrowed lumbar canal\n* Patient with polyneuropathy or myelopathy\n* Patient with sequelae of neuropathic pain"}, 'identificationModule': {'nctId': 'NCT05000658', 'acronym': 'Dexhia', 'briefTitle': 'Efficacy of Soluble Dexamethasone in Refractory Sciatica', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo', 'orgStudyIdInfo': {'id': 'RC21_0148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'HSC one injection of 4 mL soluble Dexamethasone phosphate (16 mg) (equivalent to 100 mg Prednisone), followed by up to 16 mL saline (depending on tolerance)', 'interventionNames': ['Drug: Dexamethasone phosphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group B', 'description': 'HSC one injection of 4mL of saline and then up to 16 mL of saline (depending on tolerance)', 'interventionNames': ['Drug: Dexamethasone phosphate']}], 'interventions': [{'name': 'Dexamethasone phosphate', 'type': 'DRUG', 'description': 'HSC injection of 4mL', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Maugars', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}