Prediction of Transforaminal Epidural Injection Success in Sciatica

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Spaarne Gasthuis
RECRUITING
Haarlem
Contact Information
Primary
Eduard JA Verheijen, MD
e.j.a.verheijen@lumc.nl
+3171526746
Backup
Carmen LA Vleggeert-Lankamp, MD, PhD
c.l.a.vleggeert-lankamp@lumc.nl
+31715262093
Time Frame
Start Date: 2020-11-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 388
Treatments
Patients with Lumbar Disc Herniation
Patients with a lumbar disc herniation on MRI and consistent with clinical findings are screened if they have an appointment at the pain clinic for treatment with a transforaminal epidural injection.
Patients with Lumbar Spinal Stenosis
Patients with a lumbar spinal stenosis on MRI and consistent with clinical findings are screened if they have an appointment at the pain clinic for treatment with a transforaminal epidural injection.
Sponsors
Collaborators: Spaarne Gasthuis
Leads: Eduard Verheijen

This content was sourced from clinicaltrials.gov