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 ✓ ✓
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 388 is above the median of 100 across 95 observational studies indexed under Radiculopathy.
Browse Radiculopathy studies →This is the only study on the registry with Eduard Verheijen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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