Clinical trial NCT04540068: Prediction of TEI Success in Sciatica
Official title: Prediction of Transforaminal Epidural Injection Success in Sciatica
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Radiculopathy
Lumbar Disc Herniation
Lumbar Spinal Stenosis
Keywords: Transforaminal Epidural Injection
Lumbar spine
Prospective cohort study
Prediction of success
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Spaarne Gasthuis
First posted: 2020-09-07
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 ✓ ✓

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

Primary outcomes:
measure: Numerical Rating Scale Leg Pain
timeFrame: 2 weeks
Secondary outcomes:
measure: Numerical Rating Scale Leg Pain
timeFrame: 30 minutes after treatment
measure: Numerical Rating Scale Leg Pain
timeFrame: 6 weeks
measure: Numerical Rating Scale Back Pain
timeFrame: 30 minutes after treatment
measure: Numerical Rating Scale Back Pain
timeFrame: 2 weeks
measure: Numerical Rating Scale Back Pain
timeFrame: 6 weeks
measure: Oswestry Disability Index
timeFrame: 2 weeks
measure: Oswestry Disability Index
timeFrame: 6 weeks
measure: Global Perceived Effect
timeFrame: 2 weeks
measure: Global Perceived Effect
timeFrame: 6 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 2 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 weeks
measure: Pain Coping Inventory
timeFrame: 2 weeks
measure: Pain Coping Inventory
timeFrame: 6 weeks
measure: Visual Analogue Scale Quality of Life
timeFrame: 2 weeks
measure: Visual Analogue Scale Quality of Life
timeFrame: 6 weeks
measure: Use of pain medication and physical therapy
timeFrame: 2 weeks
measure: Use of pain medication and physical therapy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
Study officials:
affiliation: Leiden University Medical Centre / Spaarne Gasthuis
name: Carmen LA Vleggeert-Lankamp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.