Health TrialsbyHealthPanel

Prediction of TEI Success in Sciatica

ConditionsLumbar RadiculopathyLumbar Disc HerniationLumbar Spinal Stenosis
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

This trial does not accept healthy volunteers

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 population

Patients suffering from lumbar radiculopathy due to lumbar disc herniation or spinal stenosis that have a scheduled appointment for treatment with TEI are screened to be candidates for this study. If the patient fulfills the inclusion and exclusion criteria the patient can participate in this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transforaminal Epidural Injection

    Drug

    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.

Treatment groups

388 Participants
are divided into 2 treatment groups
Group A: Patients with Lumbar Disc Herniation1 intervention
Group B: Patients with Lumbar Spinal Stenosis1 intervention

Trial outcomes

Primary outcomes

1

Numerical Rating Scale Leg Pain

The NRS score for leg pain

Time frame
2 weeks

Secondary outcomes

1

Numerical Rating Scale Leg Pain

The NRS score for leg pain

Time frame
30 minutes after treatment
2

Numerical Rating Scale Leg Pain

The NRS score for leg pain

Time frame
6 weeks
3

Numerical Rating Scale Back Pain

The NRS score for back pain

Time frame
30 minutes after treatment
4

Numerical Rating Scale Back Pain

The NRS score for back pain

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eduard Verheijen

Lead sponsor

Leiden University Medical Center

Sponsor institution

Spaarne Gasthuis

Collaborator

Source ClinicalTrials.gov
Apply now