An observational study in Lumbar Radiculopathy, Lumbar Disc Herniation and Lumbar Spinal Stenosis, sponsored by Eduard Verheijen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Eduard Verheijen · Observational
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.
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 ✓ ✓
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.
Exclusion Criteria:
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
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.
Also known as: Transforaminal Epidural Steroid Injection
Numerical Rating Scale Leg Pain
The NRS score for leg pain
Time frame: 2 weeks
Numerical Rating Scale Leg Pain
The NRS score for leg pain
Time frame: 30 minutes after treatment
Numerical Rating Scale Leg Pain
The NRS score for leg pain
Time frame: 6 weeks
Numerical Rating Scale Back Pain
The NRS score for back pain
Time frame: 30 minutes after treatment
Numerical Rating Scale Back Pain
The NRS score for back pain
Time frame: 2 weeks
Numerical Rating Scale Back Pain
The NRS score for back pain
Time frame: 6 weeks
Oswestry Disability Index
The ODI score for functionality
Time frame: 2 weeks
Oswestry Disability Index
The ODI score for functionality
Time frame: 6 weeks
Global Perceived Effect
The degree of patient satisfaction from experienced recovery on a Likert scale
Time frame: 2 weeks
Global Perceived Effect
The degree of patient satisfaction from experienced recovery on a Likert scale
Time frame: 6 weeks
Hospital Anxiety and Depression Scale
The HADS score for assessment of anxiety and depression
Time frame: 2 weeks
Hospital Anxiety and Depression Scale
The HADS score for assessment of anxiety and depression
Time frame: 6 weeks
Pain Coping Inventory
Assessment of the pain coping mechanisms of the patient
Time frame: 2 weeks
Pain Coping Inventory
Assessment of the pain coping mechanisms of the patient
Time frame: 6 weeks
Visual Analogue Scale Quality of Life
The VAS for assessment of Quality of Life
Time frame: 2 weeks
Visual Analogue Scale Quality of Life
The VAS for assessment of Quality of Life
Time frame: 6 weeks
Use of pain medication and physical therapy
Use of pain medication and physical therapy
Time frame: 2 weeks
Use of pain medication and physical therapy
Use of pain medication and physical therapy
Time frame: 6 weeks
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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