Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-07 @ 2:07 PM
Study NCT ID:
NCT05062993
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2021-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-24', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale(NRS) (0-10)', 'timeFrame': 'before procedure', 'description': 'The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.'}, {'measure': 'Numeric Rating Scale', 'timeFrame': '2 weeks after procedure', 'description': 'The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.'}, {'measure': 'Numeric Rating Scale', 'timeFrame': '4 weeks after procedure', 'description': 'The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.'}, {'measure': 'Numeric Rating Scale', 'timeFrame': '8 weeks after procedure', 'description': 'The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caudal epidural stimulation', 'chronic pain', 'lumbosacral radiculopathy', 'postlumbar surgery syndrome'], 'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic pain in legs or back pain\n* unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections\n\nExclusion Criteria:\n\n* coagulation disorders\n* psychiatric disorders\n* rheumatoid disorders\n* infections'}, 'identificationModule': {'nctId': 'NCT05062993', 'briefTitle': 'Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome', 'orgStudyIdInfo': {'id': '98/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'Patients with chronic radicular pain will be included in this study. Ultrasound guided caudal epidural pulse radiofrequency technique will be applied to the study group.', 'interventionNames': ['Procedure: caudal epidural pulse radio frequency']}], 'interventions': [{'name': 'caudal epidural pulse radio frequency', 'type': 'PROCEDURE', 'description': 'A needle is inserted into the caudal epidural space under ultrasound guidance and pulse radiofrequency is administered at 5 Hz using a 5. ms pulse width for 600 seconds at 55 V.', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Yildirim Beyazit Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Selin Guven Kose', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Selin Guven Kose', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}