Actively Recruiting

Age: 18Years +
All Genders
NCT04540068

Prediction of TEI Success in Sciatica

Led by Eduard Verheijen · Updated on 2025-03-12

388

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

Sponsors

E

Eduard Verheijen

Lead Sponsor

S

Spaarne Gasthuis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prediction of TEI Success in Sciatica

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of unilateral lumbar radiculopathy due to lumbar disc herniation or one-level spinal stenosis
  • Diagnosis confirmed by magnetic resonance imaging (MRI)
  • Scheduled for transforaminal epidural injection (TEI)
  • Access to e-mail
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Severe multisegmental spinal disease
  • Anatomical abnormalities that complicate the procedure (e.g., severe scoliosis)
  • Active cancer or infectious disease
  • Use of immunosuppressive drugs
  • Use of systemic corticosteroids in the past 3 months
  • Previous TEI treatment for the current lumbar radiculopathy episode
  • History of lower back surgery at the same lumbar level
  • Conditions preventing TEI treatment (e.g., anticoagulants that cannot be paused, allergy to steroids or local anesthetics)
  • Pregnancy
  • Major language barrier

AI-Screening

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Trial Site Locations

Total: 1 location

1

Spaarne Gasthuis

Haarlem, Netherlands

Actively Recruiting

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Research Team

E

Eduard JA Verheijen, MD

CONTACT

C

Carmen LA Vleggeert-Lankamp, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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