RecruitingNCT04540068

Prediction of TEI Success in Sciatica

Prediction of Transforaminal Epidural Injection Success in Sciatica

Sponsor

Eduard Verheijen

Enrollment

388 participants

Start Date

Nov 15, 2020

Study Type

OBSERVATIONAL

Conditions

Lumbar Radiculopathy Lumbar Spinal Stenosis Lumbar Disc Herniation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study aims to predict which patients with sciatica — pain that travels down the leg from the lower back due to a compressed nerve — will benefit most from a transforaminal epidural injection (TEI), a procedure where anti-inflammatory medication (usually corticosteroid) is injected near the compressed nerve root in the spine. Not all patients respond equally to these injections, and identifying predictors of success could help doctors select the right patients and avoid unnecessary procedures in those unlikely to benefit. Participants scheduled for a TEI will complete questionnaires before and after the procedure, and researchers will analyze which clinical and imaging factors predicted a good response. You may be eligible if: - You are 18 or older - You have been diagnosed with sciatica (lumbar radiculopathy) caused by a herniated disc or single-level spinal stenosis - Your diagnosis is supported by MRI findings - You are already scheduled to have a transforaminal epidural injection - You have access to email for follow-up questionnaires You may NOT be eligible if: - You are under 18 years old - You have severe multi-level spinal disease or major spinal deformity - You have active cancer or a serious infection - You have already had a TEI for this current episode of sciatica - You are pregnant - You are taking anticoagulants that cannot be safely stopped, or have an allergy to steroids or local anesthetics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTransforaminal Epidural Injection

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.