Prediction of TEI Success in Sciatica

Study Overview
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Brief Summary
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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
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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 ✓ ✓

Official Title
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Prediction Of Transforaminal Epidural Injection Success in Sciatica

Conditions
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Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Spinal Stenosis

Intervention / Treatment
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* Drug: Transforaminal Epidural Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Lumbar Disc Herniation<br>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<br>* 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.<br>* Other names: Transforaminal Epidural Steroid Injection;|
| Patients with Lumbar Spinal Stenosis<br>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<br>* 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.<br>* Other names: Transforaminal Epidural Steroid Injection;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transforaminal Epidural Injection, Lumbar spine, Prospective cohort study, Prediction of success