Prediction of TEI Success in Sciatica

NCT ID: NCT04540068

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 388 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2026-12-31

Brief Summary

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 ✓ ✓

Conditions

Lumbar Radiculopathy; Lumbar Disc Herniation; Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Transforaminal Epidural Injection

Intervention Type: DRUG

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.

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.

Transforaminal Epidural Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Transforaminal Epidural Steroid Injection

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaarne Gasthuis

OTHER

Sponsor Role: collaborator

Eduard Verheijen

OTHER

Sponsor Role: lead

Responsible Party

Eduard Verheijen

Bsc.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carmen LA Vleggeert-Lankamp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Centre / Spaarne Gasthuis

Locations

Spaarne Gasthuis

Haarlem, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Eduard JA Verheijen, MD

Role: CONTACT

e.j.a.verheijen@lumc.nl

+3171526746

Carmen LA Vleggeert-Lankamp, MD, PhD

Role: CONTACT

c.l.a.vleggeert-lankamp@lumc.nl

+31715262093

Facility Contacts

Carmen Vleggeert-Lankamp, M.D. Ph.D

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 11887877 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31742372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27764056 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17114531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25108099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16687527 (View on PubMed)

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 stenosis. BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.

Reference Type: DERIVED

PMID: 39164613 (View on PubMed)

Other Identifiers

POTEISS

Identifier Type: -

Identifier Source: org_study_id