Clinical trial Recruiting at 1 site Observational Ages 18 and up

Predicting success of epidural injections for sciatica treatment

Official title: Prediction of Transforaminal Epidural Injection Success in Sciatica

Run by Leiden University Medical Center · NCT04540068 · Data updated 2026-11-12

This study is trying to find out which factors can help predict how well epidural injections will work for people with sciatica caused by a herniated disc or spinal stenosis.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment388 (estimated)
SponsorLeiden University Medical Center
Academic / other
Locations1 site (Haarlem)
StatusRecruiting
StartedNovember 15, 2020
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedMarch 12, 2025
Trial IDNCT04540068 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults diagnosed with unilateral lumbar radiculopathy due to lumbar disc herniation or one-level spinal stenosis, confirmed by MRI.

Probably not a fit

Patients with severe multisegmental spinal disease, active malignancy, or those who have had previous treatments for the current episode of lumbar radiculopathy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop a predictive model for treatment success following transforaminal epidural injections (TEI) in patients with lumbar radiculopathy due to lumbar disc herniation or spinal stenosis. It will collect demographic, clinical, and radiological data to identify factors that correlate with positive treatment outcomes. Additionally, the study will assess the short-term efficacy of TEI based on pain relief, functionality, and patient-reported recovery scores, as well as the rates of subsequent treatments and surgeries. The findings could help tailor treatment plans for better patient outcomes.

Why it matters

Potential benefit: If successful, this study could lead to improved patient selection for TEI, enhancing treatment effectiveness for those suffering from sciatica.

How similar studies have gone: While the approach of predicting treatment success based on clinical and radiological parameters is not widely established, similar studies have shown promise in improving treatment outcomes in related conditions.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Active malignancy or infectious disease
* Use of immunosuppressive drugs
* Use of systemic corticosteroids in preceding 3 months
* Previous treatment with TEI for current episode of lumbar radiculopathy
* History of lower back surgery at the same lumbar level
* Circumstances that prevent treatment with TEI (e.g. use of anticoagulants that cannot be temporarily discontinued, allergy against steroids or local anaesthetic)
* Pregnancy
* Major language barrier

Where it's running

  • Spaarne Gasthuis
    Haarlem, Netherlands
    Recruiting

Study contacts

  • Principal investigator: Carmen LA Vleggeert-Lankamp, MD, PhD — Leiden University Medical Centre / Spaarne Gasthuis
  • Study coordinator: Eduard JA Verheijen, MD
  • Email: e.j.a.verheijen@lumc.nl
  • Phone: +3171526746

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.