| NCT ID | NCT04540068 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eduard Verheijen |
| Condition | Lumbar Radiculopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 388 participants |
| Start Date | 2020-11-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 388 participants in total. It began in 2020-11-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Carmen LA Vleggeert-Lankamp, MD, PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Centre / Spaarne Gasthuis
Frequently Asked Questions
Who can join the NCT04540068 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Radiculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04540068 currently recruiting?
Yes, NCT04540068 is actively recruiting participants. Contact the research team at e.j.a.verheijen@lumc.nl for enrollment information.
Where is the NCT04540068 trial being conducted?
This trial is being conducted at Haarlem, Netherlands.
Who is sponsoring the NCT04540068 clinical trial?
NCT04540068 is sponsored by Eduard Verheijen. The principal investigator is Carmen LA Vleggeert-Lankamp, MD, PhD at Leiden University Medical Centre / Spaarne Gasthuis. The trial plans to enroll 388 participants.