Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
Study NCT ID:
NCT04540068
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2020-09-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of TEI Success in Sciatica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 388}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Scale Leg Pain', 'timeFrame': '2 weeks', 'description': 'The NRS score for leg pain'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale Leg Pain', 'timeFrame': '30 minutes after treatment', 'description': 'The NRS score for leg pain'}, {'measure': 'Numerical Rating Scale Leg Pain', 'timeFrame': '6 weeks', 'description': 'The NRS score for leg pain'}, {'measure': 'Numerical Rating Scale Back Pain', 'timeFrame': '30 minutes after treatment', 'description': 'The NRS score for back pain'}, {'measure': 'Numerical Rating Scale Back Pain', 'timeFrame': '2 weeks', 'description': 'The NRS score for back pain'}, {'measure': 'Numerical Rating Scale Back Pain', 'timeFrame': '6 weeks', 'description': 'The NRS score for back pain'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '2 weeks', 'description': 'The ODI score for functionality'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '6 weeks', 'description': 'The ODI score for functionality'}, {'measure': 'Global Perceived Effect', 'timeFrame': '2 weeks', 'description': 'The degree of patient satisfaction from experienced recovery on a Likert scale'}, {'measure': 'Global Perceived Effect', 'timeFrame': '6 weeks', 'description': 'The degree of patient satisfaction from experienced recovery on a Likert scale'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '2 weeks', 'description': 'The HADS score for assessment of anxiety and depression'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '6 weeks', 'description': 'The HADS score for assessment of anxiety and depression'}, {'measure': 'Pain Coping Inventory', 'timeFrame': '2 weeks', 'description': 'Assessment of the pain coping mechanisms of the patient'}, {'measure': 'Pain Coping Inventory', 'timeFrame': '6 weeks', 'description': 'Assessment of the pain coping mechanisms of the patient'}, {'measure': 'Visual Analogue Scale Quality of Life', 'timeFrame': '2 weeks', 'description': 'The VAS for assessment of Quality of Life'}, {'measure': 'Visual Analogue Scale Quality of Life', 'timeFrame': '6 weeks', 'description': 'The VAS for assessment of Quality of Life'}, {'measure': 'Use of pain medication and physical therapy', 'timeFrame': '2 weeks', 'description': 'Use of pain medication and physical therapy'}, {'measure': 'Use of pain medication and physical therapy', 'timeFrame': '6 weeks', 'description': 'Use of pain medication and physical therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transforaminal Epidural Injection', 'Lumbar spine', 'Prospective cohort study', 'Prediction of success'], 'conditions': ['Lumbar Radiculopathy', 'Lumbar Disc Herniation', 'Lumbar Spinal Stenosis']}, 'referencesModule': {'references': [{'pmid': '11887877', 'type': 'BACKGROUND', 'citation': 'Vroomen PC, de Krom MC, Knottnerus JA. Predicting the outcome of sciatica at short-term follow-up. Br J Gen Pract. 2002 Feb;52(475):119-23.'}, {'pmid': '31742372', 'type': 'BACKGROUND', 'citation': 'Sencan S, Celenlioglu AE, Asadov R, Gunduz OH. Predictive factors for treatment success of transforaminal epidural steroid injection in lumbar disc herniation-induced sciatica. Turk J Med Sci. 2020 Feb 13;50(1):126-131. doi: 10.3906/sag-1908-167.'}, {'pmid': '27764056', 'type': 'BACKGROUND', 'citation': 'Billy GG, Lin J, Gao M, Chow MX. Predictive Factors of the Effectiveness of Caudal Epidural Steroid Injections in Managing Patients With Chronic Low Back Pain and Radiculopathy. Clin Spine Surg. 2017 Jul;30(6):E833-E838. doi: 10.1097/BSD.0000000000000454.'}, {'pmid': '17114531', 'type': 'BACKGROUND', 'citation': 'Lee JW, Kim SH, Lee IS, Choi JA, Choi JY, Hong SH, Kang HS. Therapeutic effect and outcome predictors of sciatica treated using transforaminal epidural steroid injection. AJR Am J Roentgenol. 2006 Dec;187(6):1427-31. doi: 10.2214/AJR.05.1727.'}, {'pmid': '25108099', 'type': 'BACKGROUND', 'citation': 'McCormick Z, Cushman D, Casey E, Garvan C, Kennedy DJ, Plastaras C. Factors associated with pain reduction after transforaminal epidural steroid injection for lumbosacral radicular pain. Arch Phys Med Rehabil. 2014 Dec;95(12):2350-6. doi: 10.1016/j.apmr.2014.07.404. Epub 2014 Aug 7.'}, {'pmid': '16687527', 'type': 'BACKGROUND', 'citation': 'Cyteval C, Fescquet N, Thomas E, Decoux E, Blotman F, Taourel P. Predictive factors of efficacy of periradicular corticosteroid injections for lumbar radiculopathy. AJNR Am J Neuroradiol. 2006 May;27(5):978-82.'}, {'pmid': '39164613', 'type': 'DERIVED', 'citation': 'Verheijen EJA, van Haagen OBHAM, Bartels EC, van der Sloot K, van den Akker-van Marle ME, Steyerberg EW, Vleggeert-Lankamp CLA. Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis. BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Treatment with transforaminal epidural injections is part of usual care in patients suffering from lumbar radiculopathy. However, not all patients experience a satisfactory result from this treatment and it is unclear what percentage of patients responds well and if any clinical or radiological factors exist that predict a positive response.\n\nObjectives:\n\nPrimary: to develop a model based on demographic, clinical and radiological parameters for prediction of treatment success after TEI\n\nSecondary: to estimate the short-term efficacy of TEI in patients with LDH and spinal stenosis based on pain, functionality and perceived recovery scores, to determine the correlation between clinical and radiological baseline parameters and physical and psychological patient outcome measures, to determine the rate of additional injections and rate of surgery after treatment with TEI, to determine the short-term (cost)effectiveness of TEI on physical and psychological patient outcome measures, and to determine the rate of complications associated with TEI\n\nStudy design: Prospective cohort study\n\nStudy population: Patients that are scheduled for TEI as part of usual care suffering from a new episode of lumbar radiculopathy\n\nMain study parameters/endpoints: leg and back pain scores at baseline, 30 minutes, 2 and 6 weeks after treatment. ODI, HADS, Quality of Life and PCI at baseline, 2 and 6 weeks after treatment. Perceived recovery at 2 and 6 weeks after treatment. Usage of healthcare at baseline, 2 and 6 weeks after treatment.', 'detailedDescription': 'Data collection schedule Baseline Weeks of follow-up 30 min. Day 4 Week 2 Week 6 Demographic data ✓ NRS leg pain ✓ ✓ ✓ ✓ NRS back pain ✓ ✓ ✓ ✓ ODI ✓ ✓ ✓ HADS ✓ ✓ ✓ QoL VAS ✓ ✓ ✓ PCI ✓ ✓ ✓ Likert score ✓ ✓ Adjuvant therapy ✓ ✓ ✓ TEI data ✓ ✓'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from lumbar radiculopathy due to lumbar disc herniation or spinal stenosis that have a scheduled appointment for treatment with TEI are screened to be candidates for this study. If the patient fulfills the inclusion and exclusion criteria the patient can participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of unilateral lumbar radiculopathy secondary to LDH or one-level spinal stenosis\n* Diagnosis supported by magnetic resonance imaging (MRI) findings\n* Scheduled appointment for TEI\n* Access to e-mail\n* Signed informed consent\n\nExclusion Criteria:\n\n* Diagnosis of unilateral lumbar radiculopathy secondary to LDH or one-level spinal stenosis\n* Age under 18 years\n* Severe multisegmental spinal disease\n* Anatomical abnormalities that may complicate the procedure technically (e.g. severe scoliosis)\n* Active malignancy or infectious disease\n* Use of immunosuppressive drugs\n* Use of systemic corticosteroids in preceding 3 months\n* Previous treatment with TEI for current episode of lumbar radiculopathy\n* History of lower back surgery at the same lumbar level\n* Circumstances that prevent treatment with TEI (e.g. use of anticoagulants that cannot be temporarily discontinued, allergy against steroids or local anaesthetic)\n* Pregnancy\n* Major language barrier'}, 'identificationModule': {'nctId': 'NCT04540068', 'acronym': 'POTEISS', 'briefTitle': 'Prediction of TEI Success in Sciatica', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Prediction of Transforaminal Epidural Injection Success in Sciatica', 'orgStudyIdInfo': {'id': 'POTEISS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Lumbar Disc Herniation', 'description': 'Patients with a lumbar disc herniation on MRI and consistent with clinical findings are screened if they have an appointment at the pain clinic for treatment with a transforaminal epidural injection.', 'interventionNames': ['Drug: Transforaminal Epidural Injection']}, {'label': 'Patients with Lumbar Spinal Stenosis', 'description': 'Patients with a lumbar spinal stenosis on MRI and consistent with clinical findings are screened if they have an appointment at the pain clinic for treatment with a transforaminal epidural injection.', 'interventionNames': ['Drug: Transforaminal Epidural Injection']}], 'interventions': [{'name': 'Transforaminal Epidural Injection', 'type': 'DRUG', 'otherNames': ['Transforaminal Epidural Steroid Injection'], 'description': 'Injections above L3 will contain 1,5 ml lidocaine 1% and 10 mg dexamethasone and injections at L3 or below will contain 1,5 ml lidocaine 2% and 40mg methylprednisolone acetate in accordance with current Dutch anesthesiologic guidelines for usual care.', 'armGroupLabels': ['Patients with Lumbar Disc Herniation', 'Patients with Lumbar Spinal Stenosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haarlem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Carmen Vleggeert-Lankamp, M.D. Ph.D', 'role': 'CONTACT'}], 'facility': 'Spaarne Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}], 'centralContacts': [{'name': 'Eduard JA Verheijen, MD', 'role': 'CONTACT', 'email': 'e.j.a.verheijen@lumc.nl', 'phone': '+3171526746'}, {'name': 'Carmen LA Vleggeert-Lankamp, MD, PhD', 'role': 'CONTACT', 'email': 'c.l.a.vleggeert-lankamp@lumc.nl', 'phone': '+31715262093'}], 'overallOfficials': [{'name': 'Carmen LA Vleggeert-Lankamp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Centre / Spaarne Gasthuis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eduard Verheijen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spaarne Gasthuis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Bsc.', 'investigatorFullName': 'Eduard Verheijen', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}