Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT06503835
Status:
COMPLETED
Last Update Posted:
2024-07-19
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in Lumbar Radiculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D006547', 'term': 'Hernia'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '24th hours, 1st, 3rd, 6th, and 12th months', 'description': 'The VAS score for pain assessment ranges between 0-10 ( (0=no pain, 5=moderate pain, 10=extremely severe pain).'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Questionnaire (ODI)', 'timeFrame': '1st, 3rd, 6th, and 12th months', 'description': 'ODI is a questionnaire in which the level of disability increases as the total score increases. Total scores vary between 0 and 50.'}, {'measure': 'MacNab Scale Scores', 'timeFrame': '1st and 12th months', 'description': 'The MacNab scale scores were used for success in pain decrease and include excellent, good, fair, and poor. The "excellent" and "good" results were accepted as favorable outcomes, and the "fair" and "poor" results were considered unsatisfactory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Injections', 'Steroids', 'Ozone', 'Disk Herniated Lumbar'], 'conditions': ['Low Back Pain', 'Radiculopathy Lumbar', 'Hernia', 'Disk Herniated Lumbar']}, 'descriptionModule': {'briefSummary': 'This retrospective study aimed to assess the clinical effectiveness and safety of transforaminal epidural injections of steroid and ozone mixture versus steroid alone in low back and radicular leg pain related to disk herniation.', 'detailedDescription': "Low back and radicular leg pain due to radiculopathy are the common presenting symptoms in the field of pain medicine.For patients with chronic low back and radicular leg pain, pain relief can be achieved through minimally invasive interventional procedures under fluoroscopic guidance. Since some patients may experience persistent pain and the potential development risk of failed back surgery syndrome, minimally invasive procedures are preferred as a pre-surgical intervention.\n\nInterlaminar or transforaminal epidural steroid injections are the most commonly used nonsurgical interventions for disc herniation. Ozone therapy has also started to be used as frequently as steroids. Previous studies have shown that ozone can be given through intradiscally, epidural space, and paravertebral muscles. Ozone gase is thought to modulate levels of cytokines and prostaglandins, minimize reactive oxidant species levels, and improve local periganglionic circulation.\n\nThe objective of this study was to assess the short- and long-term clinical efficacy of transforaminal epidural steroid and steroid plus ozone injection in patients presenting with low back and radicular leg pain and to analyze which treatment method is most beneficial in reducing pain relief.\n\nThis was a retrospective study of 120 patients who underwent transforaminal epidural steroid or combination of steroid and ozone injection between June and December 2020 in the Ankara University Faculty of Medicine, Department of Pain Medicine.\n\nDemographic information, pain intensity, localization, pattern (neuropathic/nonneuropathic/mix), and patients' quality of life and the treated level (the innervation territories of L2 (Lomber), L3, L4, L5, or S1 (Sacral)) were analyzed. Pain intensity was assessed with the Visual Analog Scale (VAS), and patient disability was evaluated with the Oswestry Disability Questionnaire (ODI).\n\nOne group included patients who underwent transforaminal epidural steroid and ozone injection, and another group included patients who underwent transforaminal epidural steroid injection alone. In both groups, two mL of dexamethasone (8 mg) and 3 mL of saline were used for each transforaminal epidural injection level. Patients who received combination therapy were injected 5ml of ozone at a concentration of 28 g/ml in addition to steroids for each level.\n\nThe investigators evaluated the patients' records of VAS and ODI scores on the day of the procedure and at the 24th hours (for VAS only) 1st, 3rd, 6th, and 12th months after the procedure. Patients' satisfaction was assessed using modified MacNab scale scores after the 1st and 12th months. The post-treatment results of the patients were compared between the two groups and with the baseline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '120 patients (age range, 18-72 years) who underwent transforaminal epidural steroid or combination of steroid and ozone injection between June and December 2020 in the Ankara University Faculty of Medicine, Department of Pain Medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Files of patients underwent transforaminal epidural steroid or combination of steroid and ozone injection\n* Age between 18-75 years\n* Body mass index (BMI) \\<35,\n* VAS score ≥ 4\n* Radicular pain not responding to conservative therapy related to lumbar disk herniation on magnetic resonance imaging\n* Duration of pain of \\>3 months\n\nExclusion Criteria:\n\n* Pregnancy\n* Major progressive neurologic deficits\n* Infective or inflammatory diseases\n* Uncontrolled diabetes or other severe internal comorbidities\n* Malignancy\n* international normalized ratio (INR) \\> 1.2\n* Glucose-6-phosphate dehydrogenase deficiency'}, 'identificationModule': {'nctId': 'NCT06503835', 'briefTitle': 'Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in Lumbar Radiculopathy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ibn Sina Hospital'}, 'officialTitle': 'Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With Lumbar Radiculopathy', 'orgStudyIdInfo': {'id': 'IbnSinaH-PM-DB-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The patients who underwent transforaminal epidural steroid and ozone injection', 'description': 'Patients who received combination therapy were injected 5ml of ozone at a concentration of 28 g/ml and two mL of dexamethasone (8 mg) and 3 mL of saline for each transforaminal epidural injection level under fluoroscopy guidance', 'interventionNames': ['Procedure: Fluoroscopy Guided Transforaminal Epidural Ozone Injection', 'Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection']}, {'label': 'The patients who underwent transforaminal epidural steroid injection alone', 'description': 'Patients who received transforaminal epidural steroid injection were injected two mL of dexamethasone (8 mg) and 3 mL of saline for each transforaminal epidural injection level.', 'interventionNames': ['Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection']}], 'interventions': [{'name': 'Fluoroscopy Guided Transforaminal Epidural Ozone Injection', 'type': 'PROCEDURE', 'description': 'All procedures were performed under light sedation in a sterile operating room. Ozone was created by an ozone generator (Dr. J. Hänsler Ozonosan, Iffezheim, Germany). Appropriate diffusion of the non-ionic contrast agent into the periradicular and epidural area was verified through anteroposterior and lateral fluoroscopic images and the injections were then safely performed. Patients who underwent transforaminal epidural steroid plus ozone injection received additionally 5ml of ozone at a concentration of 28 g/ml for each transforaminal epidural injection level.', 'armGroupLabels': ['The patients who underwent transforaminal epidural steroid and ozone injection']}, {'name': 'Fluoroscopy Guided Transforaminal Epidural Steroid Injection', 'type': 'PROCEDURE', 'description': 'All procedures were performed under light sedation in a sterile operating room.Appropriate diffusion of the non-ionic contrast agent into the periradicular and epidural area was verified through anteroposterior and lateral fluoroscopic images and the injections were then safely performed. Patients who underwent transforaminal epidural steroid injection received two mL of dexamethasone (8 mg) and 3 mL of saline for each transforaminal epidural injection level', 'armGroupLabels': ['The patients who underwent transforaminal epidural steroid and ozone injection', 'The patients who underwent transforaminal epidural steroid injection alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Faculty of Medicine, İbni Sina Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Derya Bayram, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University Faculty of Medicine, Department of Pain Medicine'}, {'name': 'İbrahim Aşık, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University Faculty of Medicine, Department of Pain Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ibn Sina Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Pain Specialist', 'investigatorFullName': 'Derya Bayram', 'investigatorAffiliation': 'Ibn Sina Hospital'}}}}