Prediction of TEI Success in Sciatica

Lumbar Spinal Stenosis Clinical Trial

— POTEISS  

Official title:

Prediction Of Transforaminal Epidural Injection Success in Sciatica

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04540068
• Other study ID #: POTEISS
• Status: Recruiting
• Start date: November 15, 2020
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Leiden University Medical Center
• Contact: Eduard JA Verheijen, Bsc.
• Phone: +3171526746
• Email: e.j.a.verheijen[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 ✓ ✓

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 388
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Lumbar Radiculopathy
• Lumbar Spinal Stenosis
• Radiculopathy
• Sciatica
• Spinal Stenosis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Spaarne Gasthuis	Haarlem

Sponsors (2)

Lead Sponsor	Collaborator
EJAVerheijen	Spaarne Gasthuis

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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