Prediction of TEI Success in Sciatica
POTEISS
Prediction of Transforaminal Epidural Injection Success in Sciatica
1 other identifier
observational
388
1 country
1
Brief Summary
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. Objectives: Primary: to develop a model based on demographic, clinical and radiological parameters for prediction of treatment success after TEI Secondary: 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 Study design: Prospective cohort study Study population: Patients that are scheduled for TEI as part of usual care suffering from a new episode of lumbar radiculopathy Main 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
November 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 12, 2025
March 1, 2025
6 years
September 1, 2020
March 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numerical Rating Scale Leg Pain
The NRS score for leg pain
2 weeks
Secondary Outcomes (17)
Numerical Rating Scale Leg Pain
30 minutes after treatment
Numerical Rating Scale Leg Pain
6 weeks
Numerical Rating Scale Back Pain
30 minutes after treatment
Numerical Rating Scale Back Pain
2 weeks
Numerical Rating Scale Back Pain
6 weeks
- +12 more secondary outcomes
Study Arms (2)
Patients with Lumbar Disc Herniation
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.
Patients with Lumbar Spinal Stenosis
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Diagnosis of unilateral lumbar radiculopathy secondary to LDH or one-level spinal stenosis
- Diagnosis supported by magnetic resonance imaging (MRI) findings
- Scheduled appointment for TEI
- Access to e-mail
- Signed informed consent
You may not qualify if:
- Diagnosis of unilateral lumbar radiculopathy secondary to LDH or one-level spinal stenosis
- Age under 18 years
- Severe multisegmental spinal disease
- Anatomical abnormalities that may complicate the procedure technically (e.g. severe scoliosis)
- Active malignancy or infectious disease
- Use of immunosuppressive drugs
- Use of systemic corticosteroids in preceding 3 months
- Previous treatment with TEI for current episode of lumbar radiculopathy
- History of lower back surgery at the same lumbar level
- Circumstances that prevent treatment with TEI (e.g. use of anticoagulants that cannot be temporarily discontinued, allergy against steroids or local anaesthetic)
- Pregnancy
- Major language barrier
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eduard Verheijenlead
- Spaarne Gasthuiscollaborator
Study Sites (1)
Spaarne Gasthuis
Haarlem, Netherlands
Related Publications (7)
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: 11887877BACKGROUNDSencan 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: 31742372BACKGROUNDBilly 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: 27764056BACKGROUNDLee 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: 17114531BACKGROUNDMcCormick 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: 25108099BACKGROUNDCyteval 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: 16687527BACKGROUNDVerheijen 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.
PMID: 39164613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen LA Vleggeert-Lankamp, MD, PhD
Leiden University Medical Centre / Spaarne Gasthuis
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Bsc.
Study Record Dates
First Submitted
September 1, 2020
First Posted
September 7, 2020
Study Start
November 15, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share