Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT04876612
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2021-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ODI (Oswestry Disability Index) change', 'timeFrame': '4 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in ODI compared to the baseline was measured at the outpatient visit.'}], 'secondaryOutcomes': [{'measure': 'ODI (Oswestry Disability Index) change', 'timeFrame': '8 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in ODI compared to the baseline was measured at the outpatient visit.'}, {'measure': 'ODI (Oswestry Disability Index) change', 'timeFrame': '12 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in ODI compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Treadmill test change', 'timeFrame': '4 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in treadmill test compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Treadmill test change', 'timeFrame': '8 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in treadmill test compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Treadmill test change', 'timeFrame': '12 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in treadmill test compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Numeric Rating Scale (NRS) change', 'timeFrame': '4 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in NRS compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Numeric Rating Scale (NRS) change', 'timeFrame': '8 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in NRS compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Numeric Rating Scale (NRS) change', 'timeFrame': '12 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in NRS compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Euroqol-5 Dimensions Questionnaire (EQ-5D) change', 'timeFrame': '4 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in EQ-5D compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Euroqol-5 Dimensions Questionnaire (EQ-5D) change', 'timeFrame': '8 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in EQ-5D compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Euroqol-5 Dimensions Questionnaire (EQ-5D) change', 'timeFrame': '12 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in EQ-5D compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Beck Depression Inventory (BPI) change', 'timeFrame': '4 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in BPI compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Beck Depression Inventory (BPI) change', 'timeFrame': '8 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in BPI compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Beck Depression Inventory (BPI) change', 'timeFrame': '12 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in BPI compared to the baseline was measured at the outpatient visit.'}, {'measure': 'Changes in analgesic drugs', 'timeFrame': '12 weeks after placebo or limaprost (Opalmon®)', 'description': 'The change in analgesic drugs compared to the baseline was measured at the outpatient visit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered compared to the placebo group.', 'detailedDescription': 'This study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (TFESI) is performed.\n\nThe subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo TFESI for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (LSS).\n\nAll study subjects are presented with TFESI at the level appropriate for their symptoms in the operating room and then returned to the recovery room. All participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure.\n\nPatients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving TFESI. Patients assigned to the trial group will take limaprost (Opalmon®) three times a day, one tablet once from the first day after receiving TFESI. In both groups, the drug was administered for 12 weeks.\n\nIn both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only Acetaminophen was allowed as a rescue drug.\n\nAfter TFESI, visits at 4 weeks, 8 weeks and 12 weeks to collect each measurement variable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 18 to 85 years\n\nPatients with a new or known diagnosis of lumbar spinal stenosis on Magnetic Resonance Imaging (MRI)\n\nPatients scheduled to undergo TFESI due to low back pain or leg pain\n\nExclusion Criteria:\n\nRefusal of a patient\n\nCoagulopathy\n\nSystemic infection or local infection at the needle injection site\n\nPatients with lumbar instability\n\nNeoplasms in the needle path\n\nAllergy to amide-type local anesthetics\n\nDecreased cognition to the extent that NRS is incomprehensible\n\nPatients with peripheral vascular disease (including peripheral arterial disease)\n\nPatients taking anticoagulant or antiplatelet drugs\n\nPatients with severe cardiovascular disease or liver or kidney disease\n\nPatinets with cerebral infarction\n\nPatinets with a history of gastrointestinal bleeding\n\nPatinets who have had lumbar spine surgery or are expected to receive it within 12 months\n\nPatients who show positive in the straight leg elevation test\n\nPatients who are allergic or sensitive to limaprost (Opalmon®) and placebo or their ingredients'}, 'identificationModule': {'nctId': 'NCT04876612', 'briefTitle': 'Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University'}, 'officialTitle': 'Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2102-086-119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Patients who received placebo after transforminal epidural steroid injection', 'description': 'Patients who took placebo for 12 weeks after TFESI', 'interventionNames': ['Procedure: Transforaminal epidural steroid injection (TFESI)']}, {'type': 'EXPERIMENTAL', 'label': 'Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection', 'description': 'Patients who took limaprost (Opalmon®) for 12 weeks after TFESI', 'interventionNames': ['Procedure: Transforaminal epidural steroid injection (TFESI)']}], 'interventions': [{'name': 'Transforaminal epidural steroid injection (TFESI)', 'type': 'PROCEDURE', 'description': "Well trained pain physician performs all the fluoroscopy-guided transforaminal epidural steroid injection (TFESI), who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For TFESI, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under fluoroscopy guidance at the patient's symptom complaining level. After confirming with a contrast medium, 3 ml of 0.1875% ropivacaine and 5 mg of dexamethasone are administered.", 'armGroupLabels': ['Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection', 'Patients who received placebo after transforminal epidural steroid injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Youn Moon Jee, MD, PhD', 'role': 'CONTACT', 'email': 'jymoon0901@gmail.com', 'phone': '82-10-5299-2036'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Youn Moon Jee, MD, PhD', 'role': 'CONTACT', 'email': 'jymoon0901@gmail.com', 'phone': '821052992036'}, {'name': 'Jeongsoo Kim, MD', 'role': 'CONTACT', 'email': 'dreamsu457@gmail.com', 'phone': '821047346422'}], 'overallOfficials': [{'name': 'Youn Moon Jee, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Jeongsoo Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jeeyoun Moon', 'investigatorAffiliation': 'Seoul National University'}}}}