Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07400068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PLDD With or Without Transforaminal Epidural Steroid Injection in Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Leg Pain Intensity (NRS)', 'timeFrame': 'Baseline to 1 month after procedure', 'description': 'Change in leg pain intensity assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Back Pain Intensity (NRS)', 'timeFrame': 'Baseline to 1 month after procedure', 'description': 'Change in low back pain intensity assessed using the Numeric Rating Scale (NRS, 0-10).'}, {'measure': 'Functional Disability (Oswestry Disability Index)', 'timeFrame': 'Baseline to 1 month after procedure', 'description': 'Functional status assessed using the Oswestry Disability Index (ODI), a validated questionnaire measuring disability related to low back pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous Laser Disc Decompression', 'Transforaminal Epidural Steroid Injection', 'Minimally Invasive Spine Treatment', 'Radicular Pain', 'PLDD'], 'conditions': ['Lumbar Disc Herniation', 'Lumbar Radiculopathy']}, 'referencesModule': {'references': [{'pmid': '25919616', 'type': 'BACKGROUND', 'citation': 'Foresti ML, Ferreira ML. Lipase-catalyzed acidolysis of tripalmitin with capric acid in organic solvent medium: Analysis of the effect of experimental conditions through factorial design and analysis of multiple responses. Enzyme Microb Technol. 2010 May 5;46(6):419-29. doi: 10.1016/j.enzmictec.2010.01.002. Epub 2010 Jan 21.'}, {'pmid': '22828691', 'type': 'BACKGROUND', 'citation': 'Benyamin RM, Manchikanti L, Parr AT, Diwan S, Singh V, Falco FJ, Datta S, Abdi S, Hirsch JA. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician. 2012 Jul-Aug;15(4):E363-404.'}, {'pmid': '15591287', 'type': 'BACKGROUND', 'citation': 'Giger JM, Haddad F, Qin AX, Zeng M, Baldwin KM. Effect of unloading on type I myosin heavy chain gene regulation in rat soleus muscle. J Appl Physiol (1985). 2005 Apr;98(4):1185-94. doi: 10.1152/japplphysiol.01099.2004. Epub 2004 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate the clinical outcomes of patients with single-level lumbar disc herniation who undergo routine percutaneous laser disc decompression (PLDD).\n\nIn routine clinical practice, some patients receive an additional transforaminal anterior epidural steroid injection during the same session without an extra puncture. This study will prospectively follow patients who receive PLDD alone and those who receive PLDD combined with epidural steroid injection.\n\nPain intensity, functional status, analgesic use, need for additional interventions, and complications will be assessed over time. The results may help to clarify whether adding epidural steroid injection to PLDD improves clinical outcomes in patients with lumbar disc herniation.', 'detailedDescription': 'This is a prospective, single-center observational study conducted at the Algology Clinic of Mersin University Faculty of Medicine. The study will include adult patients with single-level lumbar disc herniation confirmed by magnetic resonance imaging who undergo routine percutaneous laser disc decompression (PLDD) as part of standard clinical care.\n\nAccording to routine clinical practice and physician decision, some patients receive adjunct transforaminal anterior epidural steroid injection with dexamethasone in the same session following PLDD using the same cannula after withdrawal from the disc space and confirmation of epidural position with contrast under fluoroscopy. This combined approach does not require an additional puncture and is part of standard clinical treatment.\n\nPatients will be prospectively followed and divided into two groups based on routine clinical management: those undergoing PLDD alone and those undergoing PLDD with adjunct transforaminal epidural steroid injection.\n\nBaseline demographic data including age and sex, clinical characteristics such as symptom duration and affected disc level, and comorbidities will be recorded using standardized data collection forms.\n\nThe primary outcome measure will be change in leg pain intensity assessed by the Numeric Rating Scale (NRS). Secondary outcome measures will include back pain NRS, functional status evaluated using the Oswestry Disability Index (ODI), analgesic consumption, need for additional interventions, and complication rates.\n\nFollow-up assessments will be conducted at baseline, 2 weeks, 6 weeks, 3 months, and 6 months after the procedure through outpatient visits or telephone interviews.\n\nAll procedures included in this study are part of routine clinical practice, and no experimental interventions will be performed. Data will be collected and analyzed in accordance with ethical standards and patient confidentiality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18 years and older with single-level lumbar disc herniation confirmed by magnetic resonance imaging who undergo routine percutaneous laser disc decompression at a tertiary university algology clinic will be included. Patients may receive PLDD alone or PLDD combined with adjunct transforaminal anterior epidural steroid injection according to routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 years and older\n\nDiagnosis of single-level lumbar disc herniation confirmed by magnetic resonance imaging (MRI)\n\nPresence of radicular leg pain refractory to conservative treatment\n\nUndergoing routine percutaneous laser disc decompression (PLDD) as part of standard clinical care\n\nAbility to provide informed consent\n\nExclusion Criteria:\n\nMultilevel lumbar disc herniation\n\nExtruded or sequestered disc herniation\n\nSevere spinal canal stenosis or spinal instability\n\nPrevious lumbar spine surgery at the affected level\n\nActive infection or systemic inflammatory disease\n\nCoagulopathy or use of anticoagulant therapy contraindicating intervention\n\nPregnancy\n\nInability to complete follow-up assessments'}, 'identificationModule': {'nctId': 'NCT07400068', 'acronym': 'PLDD-TFESI', 'briefTitle': 'PLDD With or Without Transforaminal Epidural Steroid Injection in Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'Effect of Adjunct Transforaminal Anterior Epidural Steroid Injection Following Percutaneous Laser Disc Decompression in Patients With Single-Level Lumbar Disc Herniation: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'MU-PLDD-TFESI-2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PLDD Alone', 'description': 'Patients with single-level lumbar disc herniation who undergo routine percutaneous laser disc decompression (PLDD) as part of standard clinical care without adjunct epidural steroid injection.', 'interventionNames': ['Procedure: Percutaneous Laser Disc Decompression (PLDD)']}, {'label': 'PLDD Plus Transforaminal Epidural Steroid Injection', 'description': 'Patients with single-level lumbar disc herniation who undergo routine percutaneous laser disc decompression (PLDD) followed by adjunct transforaminal anterior epidural steroid injection with dexamethasone during the same session as part of standard clinical care.', 'interventionNames': ['Procedure: Transforaminal Anterior Epidural Steroid Injection']}], 'interventions': [{'name': 'Percutaneous Laser Disc Decompression (PLDD)', 'type': 'PROCEDURE', 'description': 'Routine minimally invasive laser-based disc decompression performed under fluoroscopic guidance to reduce intradiscal pressure in patients with lumbar disc herniation.', 'armGroupLabels': ['PLDD Alone']}, {'name': 'Transforaminal Anterior Epidural Steroid Injection', 'type': 'PROCEDURE', 'description': 'Routine transforaminal anterior epidural injection of dexamethasone performed under fluoroscopic guidance following PLDD during the same session without additional puncture.', 'armGroupLabels': ['PLDD Plus Transforaminal Epidural Steroid Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33130', 'city': 'Mersin', 'state': 'Yenişehir', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mesut Bakır, Assoc. Prof.', 'role': 'CONTACT', 'email': 'mesutbakir@mersin.edu.tr', 'phone': '+90 545 745 06 55'}], 'facility': 'Mersin University Faculty of Medicine, Department of Algology', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'centralContacts': [{'name': 'Mesut Bakır, Assoc.Prof', 'role': 'CONTACT', 'email': 'mesutbakir@gmail.com', 'phone': '+905457450655'}], 'overallOfficials': [{'name': 'Mesut Bakır', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mersin University Faculty of Medicine, Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to patient confidentiality considerations and institutional data protection policies. The collected data will be used solely for the purposes of this study and related scientific publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology and Algology', 'investigatorFullName': 'Mesut Bakır', 'investigatorAffiliation': 'Mersin University'}}}}