Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT03023969
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2017-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-05', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-17', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain alleviation by visual analogue scale (VAS)', 'timeFrame': '12 months', 'description': 'assessing pain alleviation by visual analogue scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Reduction of disk herniation by MRI', 'timeFrame': '6 months', 'description': 'evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI'}, {'measure': 'Pain alleviation using Oswestry Low Back Pain Questionnaire', 'timeFrame': '12 months', 'description': 'using Oswestry Low Back Pain Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain, Chronic']}, 'referencesModule': {'references': [{'pmid': '29357333', 'type': 'DERIVED', 'citation': 'Elawamy A, Kamel EZ, Hassanien M, Wahba OM, Amin SE. Implication of Two Different Doses of Intradiscal Ozone-Oxygen Injection upon the Pain Alleviation in Patients with Low Back Pain: A Randomized, Single-Blind Study. Pain Physician. 2018 Jan;21(1):E25-E31.'}]}, 'descriptionModule': {'briefSummary': 'Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.', 'detailedDescription': 'Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.\n\nEpidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.\n\nOzone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients Suffered radicular leg pain and some reported additional back pain.\n* All patients are non-responsive to conservative treatment modalities with VAS more than 7.\n\nExclusion criteria\n\n* presence of bleeding disorder\n* local infection\n* uncontrolled or degenerative spine disease\n* pregnancy\n* multilevel disk involvement\n* patient refusal.'}, 'identificationModule': {'nctId': 'NCT03023969', 'briefTitle': 'Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study', 'orgStudyIdInfo': {'id': 'IRB00009908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2', 'interventionNames': ['Drug: ozone oxygen mixture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.', 'interventionNames': ['Drug: ozone oxygen mixture']}], 'interventions': [{'name': 'ozone oxygen mixture', 'type': 'DRUG', 'description': 'receive 10 ml of ozone oxygen mixture under variable dosing', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia and ICU', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}