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Prediction of TEI Success in Sciatica

Recruitingn/aAges 18 Years - anyAllEduard Verheijen
NCT04540068 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 determ

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Transforaminal Epidural Injection
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Where

1 site
Spaarne Gasthuis
Haarlem, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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