Predicting the outcome of sciatica at short-term follow-up.
Patrick C A J Vroomen, M C T F M de Krom, J A Knottnerus
https://pubmed.ncbi.nlm.nih.gov/11887877Actively Recruiting
Age: 18Years +
All Genders
ID04540068
Prediction of Transforaminal Epidural Injection Success in Patients with Lumbar Radiculopathy Due to Lumbar Disc Herniation or Spinal Stenosis
Led by Eduard Verheijen · Updated on 2025-03-12
388
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Eduard Verheijen
Lead Sponsor
S
Spaarne Gasthuis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the success of transforaminal epidural injections (TEI) in patients with lumbar radiculopathy caused by lumbar disc herniation or spinal stenosis. The study aims to develop a model using demographic, clinical, and radiological factors to predict which patients will respond well to TEI treatment. The research also looks at the short-term effects of TEI on pain, function, recovery, healthcare usage, and complications. Participants receive TEI as part of their usual care. Injections above the L3 vertebra contain lidocaine 1% and dexamethasone, while injections at L3 or below contain lidocaine 2% and methylprednisolone acetate. Patients are grouped based on whether they have lumbar disc herniation or spinal stenosis, with treatment given according to current guidelines. Participants are assessed at several time points: baseline, 30 minutes, 2 weeks, and 6 weeks after treatment. Data collected include pain scores for leg and back pain, disability index, anxiety and depression scale, quality of life, pain coping, perceived recovery, and healthcare use. These measures help researchers understand the short-term effects and identify factors that predict treatment success.
CONDITIONS
Brief Title
Prediction of TEI Success in Sciatica
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of unilateral lumbar radiculopathy secondary to lumbar disc herniation or one-level spinal stenosis
- Diagnosis supported by magnetic resonance imaging (MRI) findings
- Scheduled appointment for transforaminal epidural injection (TEI)
- Access to email
- Signed informed consent
- Age 18 years or older
You will not qualify if you...
- Age under 18 years
- Severe multisegmental spinal disease
- Anatomical abnormalities complicating procedure (e.g., severe scoliosis)
- Active malignancy or infectious disease
- Use of immunosuppressive drugs
- Use of systemic corticosteroids in past 3 months
- Previous TEI treatment for current lumbar radiculopathy episode
- History of lower back surgery at the same lumbar level
- Conditions preventing TEI (e.g., anticoagulant use that cannot be stopped, allergy to steroids or anesthetics)
- Pregnancy
- Major language barrier
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Single treatment event
Participants receive a transforaminal epidural injection as part of usual care for lumbar radiculopathy.
1 treatment visit (in-person)
Monitoring
Duration - 6 weeks
Participants are monitored for pain, disability, quality of life, and psychological factors following the injection.
5 follow-up assessments: at 30 minutes, Day 4, Week 2, and Week 6 after treatment
Trial Site Locations
Total: 1 location
1
Spaarne Gasthuis
Haarlem, Netherlands
Actively Recruiting
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Research Team
E
Eduard JA Verheijen, MD
C
Carmen LA Vleggeert-Lankamp, MD, PhD
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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Published Research Related To This Trial
Predictive factors for treatment success of transforaminal epidural steroid injection in lumbar disc herniation-induced sciatica.
Savaş Şencan, Alp Eren Çelenlioğlu, Ruslan Asadov...
https://pubmed.ncbi.nlm.nih.gov/31742372Predictive Factors of the Effectiveness of Caudal Epidural Steroid Injections in Managing Patients With Chronic Low Back Pain and Radiculopathy.
Gregory G Billy, Ji Lin, Mengzhao Gao...
https://pubmed.ncbi.nlm.nih.gov/27764056Therapeutic effect and outcome predictors of sciatica treated using transforaminal epidural steroid injection.
Joon Woo Lee, Sung Hyun Kim, In Sook Lee...
https://pubmed.ncbi.nlm.nih.gov/17114531Factors associated with pain reduction after transforaminal epidural steroid injection for lumbosacral radicular pain.
Zachary McCormick, Daniel Cushman, Ellen Casey...
https://pubmed.ncbi.nlm.nih.gov/25108099Predictive factors of efficacy of periradicular corticosteroid injections for lumbar radiculopathy.
C Cyteval, N Fescquet, E Thomas...
https://pubmed.ncbi.nlm.nih.gov/16687527Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis.
E J A Verheijen, O B H A M van Haagen, E C Bartels...
https://pubmed.ncbi.nlm.nih.gov/39164613