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Recruiting NCT04540068

Prediction of TEI Success in Sciatica

— Observational Lumbar Radiculopathy Lumbar Disc Herniation Lumbar Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transforaminal Epidural Injection.
Who it may be relevant to
Registry conditions: Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Spinal Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prediction of Transforaminal Epidural Injection Success in Sciatica

Overview

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.

Detailed description

Data collection schedule Baseline Weeks of follow-up 30 min. Day 4 Week 2 Week 6 Demographic data ✓ NRS leg pain ✓ ✓ ✓ ✓ NRS back pain ✓ ✓ ✓ ✓ ODI ✓ ✓ ✓ HADS ✓ ✓ ✓ QoL VAS ✓ ✓ ✓ PCI ✓ ✓ ✓ Likert score ✓ ✓ Adjuvant therapy ✓ ✓ ✓ TEI data ✓ ✓

Interventions

  • Drug Transforaminal Epidural Injection
    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.

Primary outcome measures

  • Numerical Rating Scale Leg Pain [Time frame: 2 weeks]
Secondary outcome measures (12)
  • Numerical Rating Scale Leg Pain [Time frame: 30 minutes after treatment]
  • Numerical Rating Scale Leg Pain [Time frame: 6 weeks]
  • Numerical Rating Scale Back Pain [Time frame: 30 minutes after treatment]
  • Numerical Rating Scale Back Pain [Time frame: 2 weeks]
  • Numerical Rating Scale Back Pain [Time frame: 6 weeks]
  • Oswestry Disability Index [Time frame: 2 weeks]
  • Oswestry Disability Index [Time frame: 6 weeks]
  • Global Perceived Effect [Time frame: 2 weeks]
  • Global Perceived Effect [Time frame: 6 weeks]
  • Hospital Anxiety and Depression Scale [Time frame: 2 weeks]
  • Hospital Anxiety and Depression Scale [Time frame: 6 weeks]
  • Pain Coping Inventory [Time frame: 2 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Spaarne Gasthuis — Haarlem

Publications

  • Vroomen PC, de Krom MC, Knottnerus JA. Predicting the outcome of sciatica at short-term follow-up. Br J Gen Pract. 2002 Feb;52(475):119-23. PMID 11887877
  • Sencan S, Celenlioglu AE, Asadov R, Gunduz OH. Predictive factors for treatment success of transforaminal epidural steroid injection in lumbar disc herniation-induced sciatica. Turk J Med Sci. 2020 Feb 13;50(1):126-131. doi: 10.3906/sag-1908-167. PMID 31742372
  • Billy GG, Lin J, Gao M, Chow MX. Predictive Factors of the Effectiveness of Caudal Epidural Steroid Injections in Managing Patients With Chronic Low Back Pain and Radiculopathy. Clin Spine Surg. 2017 Jul;30(6):E833-E838. doi: 10.1097/BSD.0000000000000454. PMID 27764056
  • Lee JW, Kim SH, Lee IS, Choi JA, Choi JY, Hong SH, Kang HS. Therapeutic effect and outcome predictors of sciatica treated using transforaminal epidural steroid injection. AJR Am J Roentgenol. 2006 Dec;187(6):1427-31. doi: 10.2214/AJR.05.1727. PMID 17114531
  • McCormick Z, Cushman D, Casey E, Garvan C, Kennedy DJ, Plastaras C. Factors associated with pain reduction after transforaminal epidural steroid injection for lumbosacral radicular pain. Arch Phys Med Rehabil. 2014 Dec;95(12):2350-6. doi: 10.1016/j.apmr.2014.07.404. Epub 2014 Aug 7. PMID 25108099
  • Cyteval C, Fescquet N, Thomas E, Decoux E, Blotman F, Taourel P. Predictive factors of efficacy of periradicular corticosteroid injections for lumbar radiculopathy. AJNR Am J Neuroradiol. 2006 May;27(5):978-82. PMID 16687527
  • Verheijen EJA, van Haagen OBHAM, Bartels EC, van der Sloot K, van den Akker-van Marle ME, Steyerberg EW, Vleggeert-Lankamp CLA. Prediction 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 s PMID 39164613

Identifiers

NCT: NCT04540068 · POTEISS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗