Prediction of TEI Success in Sciatica (POTEISS)

Prediction Of Transforaminal Epidural Injection Success in Sciatica

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis; Lumbar Radiculopathy
• Intervention / Treatment: Drug: Transforaminal Epidural Injection

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 ✓ ✓

• Study Type: Observational
• Enrollment (Estimated): 388

Contacts and Locations

• Study Contact: Name: Eduard JA Verheijen, Bsc.; Phone Number: +3171526746; Email: e.j.a.verheijen@lumc.nl
• Study Contact Backup: Name: Carmen LA Vleggeert-Lankamp, MD, PhD; Phone Number: +31715262093; Email: c.l.a.vleggeert-lankamp@lumc.nl

Study Locations

• Netherlands
  • Haarlem, Netherlands
    • Recruiting
    • Spaarne Gasthuis
    • Contact: Carmen Vleggeert-Lankamp, M.D. Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from lumbar radiculopathy due to lumbar disc herniation or spinal stenosis that have a scheduled appointment for treatment with TEI are screened to be candidates for this study. If the patient fulfills the inclusion and exclusion criteria the patient can participate in this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: Transforaminal Epidural Steroid Injection
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.	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.; Other Names: Transforaminal Epidural Steroid Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale Leg Pain	The NRS score for leg pain	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale Leg Pain	The NRS score for leg pain	30 minutes after treatment
Numerical Rating Scale Leg Pain	The NRS score for leg pain	6 weeks
Numerical Rating Scale Back Pain	The NRS score for back pain	30 minutes after treatment
Numerical Rating Scale Back Pain	The NRS score for back pain	2 weeks
Numerical Rating Scale Back Pain	The NRS score for back pain	6 weeks
Oswestry Disability Index	The ODI score for functionality	2 weeks
Oswestry Disability Index	The ODI score for functionality	6 weeks
Global Perceived Effect	The degree of patient satisfaction from experienced recovery on a Likert scale	2 weeks
Global Perceived Effect	The degree of patient satisfaction from experienced recovery on a Likert scale	6 weeks
Hospital Anxiety and Depression Scale	The HADS score for assessment of anxiety and depression	2 weeks
Hospital Anxiety and Depression Scale	The HADS score for assessment of anxiety and depression	6 weeks
Pain Coping Inventory	Assessment of the pain coping mechanisms of the patient	2 weeks
Pain Coping Inventory	Assessment of the pain coping mechanisms of the patient	6 weeks
Visual Analogue Scale Quality of Life	The VAS for assessment of Quality of Life	2 weeks
Visual Analogue Scale Quality of Life	The VAS for assessment of Quality of Life	6 weeks
Use of pain medication and physical therapy	Use of pain medication and physical therapy	2 weeks
Use of pain medication and physical therapy	Use of pain medication and physical therapy	6 weeks

Collaborators and Investigators

• Sponsor: EJAVerheijen
• Collaborators: Spaarne Gasthuis
• Investigators: Principal Investigator: Carmen LA Vleggeert-Lankamp, MD, PhD, Leiden University Medical Centre / Spaarne Gasthuis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Transforaminal Epidural Injection; Lumbar spine; Prospective cohort study; Prediction of success
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Sciatica; Intervertebral Disc Displacement; Radiculopathy; Spinal Stenosis
• Other Study ID Numbers: POTEISS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No