Prediction of TEI Success in Sciatica

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEduard Verheijen

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

388 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Eduard Verheijen

Lead sponsor

Leiden University Medical Center

Sponsor institution

Spaarne Gasthuis

Collaborator