Prediction of TEI Success in Sciatica
Recruiting now
Conditions studied: Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Spinal Stenosis
In brief
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.
Key facts
- Study ID
- NCT04540068
- Run by
- Eduard Verheijen
- People needed
- 388
- Starts
- 2020-11-15
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Spaarne Gasthuis — Haarlem, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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