Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-28 @ 2:51 PM
Study NCT ID:
NCT06748469
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2024-12-22', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric rating scale on pain severity (0 = no pain, 10 = unbearable pain))', 'timeFrame': '1, 3, and 6 months', 'description': 'Change in pain severity'}], 'secondaryOutcomes': [{'measure': 'Global perceived effect (GPE)', 'timeFrame': '1, 3, and 6 months', 'description': 'Change in GPE scores according to the 7-point Likert scale (1=worst, 7=best) over time will be used to assess patient satisfaction and improvement'}, {'measure': 'Oswetry disability index (ODI)', 'timeFrame': '0, 1, 3, and 6 months', 'description': 'Change in 10-item Oswestry disability index (ODI) questionnaire (range: 0-100; 0 = no disablility) over time will be used to assess physical function'}, {'measure': 'Patient satisfaction', 'timeFrame': '1, 3, and 6 months', 'description': 'Change in Patient satisfaction (5-point Likert scale, 0= very disappointed, 5=very satisfied) over time will be used'}, {'measure': 'Change in analgesic use', 'timeFrame': '1, 3, and 6 months', 'description': 'Change in analgesic use over time (0=same, 1=decreased, 2=increased)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RADICULAR PAIN', 'DORSAL ROOT GANGLIA', 'PULSED RADIOFREQUENCY'], 'conditions': ['RADICULAR PAIN']}, 'referencesModule': {'references': [{'pmid': '31337167', 'type': 'BACKGROUND', 'citation': 'Wan C, Dong DS, Song T. High-Voltage, Long-Duration Pulsed Radiofrequency on Gasserian Ganglion Improves Acute/Subacute Zoster-Related Trigeminal Neuralgia: A Randomized, Double-Blinded, Controlled Trial. Pain Physician. 2019 Jul;22(4):361-368.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31337167/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Brief Summary:\n\nThis study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. The PRF procedure will be applied to the dorsal root ganglion (DRG) under fluoroscopic guidance.', 'detailedDescription': 'In this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. After identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. The tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. Once the RF cannula is properly positioned, an RF electrode will be inserted through the cannula and connected to the RF generator. The final position of the RF cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 V and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold.\n\nIn the short-duration PRF group, a PRF cycle will be applied at 42°C for 240 seconds, while in the long-duration group, it will be applied at 42°C for 480 seconds. Following the PRF application, epidural spread will be confirmed using contrast dye, after which 4 mL of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients to undergo DRG PRF for lumbar radicular pain in bilkent city hospital algology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge ≥ 18 years\n\n* Pain severity NRS ≥ 4\n* Pain duration \\> 12 weeks Refractory to conservative treatments (physical therapy, medical treatments) Exclusion Criteria Malignancy-related pain Diagnosis of diabetes mellitus or polyneuropathy Back pain more severe than leg pain Conditions that impair follow-up (e.g., psychiatric disorders, dementia) Patients refusing the procedure'}, 'identificationModule': {'nctId': 'NCT06748469', 'briefTitle': 'Efficacy of Pulse Radiofrequency Durations in Lumbosacral Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Analgesic Efficacy of Different Pulse Radiofrequency Treatment Durations in the Management of Lumbosacral Radicular Pain', 'orgStudyIdInfo': {'id': 'TABED 1-24-764'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with lumbosacral radicular pain', 'description': 'patients with lumbosacral radicular pain resistant to conservative treatments', 'interventionNames': ['Procedure: The duration of the intervention will be 240 seconds', 'Procedure: Dorsal Root Ganglion pulsed radiofrequency 480sec']}], 'interventions': [{'name': 'The duration of the intervention will be 240 seconds', 'type': 'PROCEDURE', 'description': 'Dorsal Root Ganglion pulsed radiofrequency 240sec', 'armGroupLabels': ['patients with lumbosacral radicular pain']}, {'name': 'Dorsal Root Ganglion pulsed radiofrequency 480sec', 'type': 'PROCEDURE', 'description': 'The duration of the intervention will be 480 seconds', 'armGroupLabels': ['patients with lumbosacral radicular pain']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'GULCIN BABAOGLU, MD', 'role': 'CONTACT', 'email': 'gulcinpektasli@gmail.com', 'phone': '+905067130979'}], 'facility': 'Ankara Bilkent City Hospital Pain Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Gulcin Babaoglu, MD', 'role': 'CONTACT', 'email': 'gulcinpektasli@gmail.com', 'phone': '+905067130979'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "ı don't want"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Gülçin Babaoğlu', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}