About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Transforaminal Epidural Injection
Treatment groups
Sponsors and collaborators
Eduard Verheijen
Lead sponsor
Leiden University Medical Center
Sponsor institution
Spaarne Gasthuis
Collaborator