Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-05 @ 1:20 PM
Study NCT ID:
NCT06239857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D055111', 'term': 'Failed Back Surgery Syndrome'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain severity score', 'timeFrame': 'A single point in time (pre-procedural time)', 'description': 'Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.'}, {'measure': 'Change in pain severity score', 'timeFrame': 'A single point in time (post-procedural 1.month)', 'description': 'Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.'}, {'measure': 'Change in pain severity score', 'timeFrame': 'A single point in time (post-procedural 3.month)', 'description': 'Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.'}, {'measure': 'Change in pain severity score', 'timeFrame': 'A single point in time (post-procedural 6.month)', 'description': 'Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.'}, {'measure': 'Change in pain severity score', 'timeFrame': 'A single point in time (post-procedural 12.month)', 'description': 'Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.'}, {'measure': 'Change in the number of patients with neuropathic pain', 'timeFrame': 'A single point in time (pre-procedural time)', 'description': 'The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.'}, {'measure': 'Change in the number of patients with neuropathic pain', 'timeFrame': 'A single point in time (post-procedural 1.month)', 'description': 'The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.'}, {'measure': 'Change in the number of patients with neuropathic pain', 'timeFrame': 'A single point in time (post-procedural 3.month)', 'description': 'The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.'}, {'measure': 'Change in the number of patients with neuropathic pain', 'timeFrame': 'A single point in time (post-procedural 6.month)', 'description': 'The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.'}, {'measure': 'Change in the number of patients with neuropathic pain', 'timeFrame': 'A single point in time (post-procedural 12.month)', 'description': 'The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Back Pain', 'Failed Back Surgery Syndrome', 'Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '40255928', 'type': 'DERIVED', 'citation': 'Erken B, Yolcu G, Saracoglu TT. Efficacy of Epidural Pulsed Radiofrequency Treatment in Persistent Spinal Pain Syndrome: A Prospective Clinical Study. Pain Res Manag. 2025 Apr 11;2025:6200102. doi: 10.1155/prm/6200102. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. A component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. Low back pain and radicular pain in the lower extremities are the main symptoms of failed back surgery syndrome (also called persistent spinal pain syndrome in new terminology).\n\nThere are many methods for treatment of failed back surgery syndrome, such as analgesic medications, physical therapy, interventional pain treatment applications, and re-surgery options. Epidural pulsed radiofrequency therapy has recently become popular among interventional pain management procedures, and studies on its effectiveness are increasing. However, studies with a multifaceted approach that also evaluate neuropathic pain are lacking in the literature. In this study, it was planned to investigate the effect of epidural pulsed radiofrequency therapy on pain palliation, including neuropathic pain, in patients diagnosed with failed back surgery syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-80\n* History of at least one operation due to lumbar disc herniation\n* Having radicular pain radiating to the lower extremities\n\nExclusion Criteria:\n\n* Having undergone surgery for an etiology other than lumbar disc herniation\n* Accompanying spinal stenosis and spondylolisthesis\n* Presence of fracture, infection, coagulopathy and pregnancy\n* Mental disorders that may negatively affect cooperation during assessments.'}, 'identificationModule': {'nctId': 'NCT06239857', 'briefTitle': 'Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Evaluation of the Effect of Epidural Pulsed Radiofrequency Treatment on Pain in Patients Diagnosed With Failed Back Surgery Syndrome (Persistant Spinal Pain Syndrome)', 'orgStudyIdInfo': {'id': '27.12.2023.700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epidural pulsed radiofrequency treatment', 'description': 'All patients diagnosed with failed back surgery syndrome will receive epidural pulsed radiofrequency treatment.', 'interventionNames': ['Procedure: Epidural pulsed radiofrequency']}], 'interventions': [{'name': 'Epidural pulsed radiofrequency', 'type': 'PROCEDURE', 'description': 'The radiofrequency treatment is applied under sterile conditions in the operating room environment. The target epidural area is reached under fluoroscopy guidance using a radiofrequency needle. After control of the needle position, radiofrequency treatment is given. Radiofrequency parameters are set as maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.', 'armGroupLabels': ['Epidural pulsed radiofrequency treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Burak Erken, MD', 'role': 'CONTACT', 'email': 'burak_erken@hotmail.com', 'phone': '+902129096000'}], 'overallOfficials': [{'name': 'Günay Yolcu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Başakşehir Çam & Sakura City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Burak Erken', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}