Lumbar RadiculopathyPOTEISSNCT04540068
Prediction of TEI Success in Sciatica
An observational study of Lumbar Radiculopathy and Lumbar Disc Herniation, run by Eduard Verheijen at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Spinal Stenosis
- What is being tested?
- Transforaminal Epidural Injection
- Type of treatment
- Injection or infusion
- How many people
- 388 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Nov 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Spaarne Gasthuis
Haarlem
Carmen Vleggeert-Lankamp, M.D. Ph.D
About this study
Official title: Prediction of Transforaminal Epidural Injection Success in Sciatica
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:
Read more
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.
Read the 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 ✓ ✓
- Being tested
- Transforaminal Epidural Injection
- Keywords
- Transforaminal Epidural Injection, Lumbar spine, Prospective cohort study, Prediction of success
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Epidural InjectionDrug
Also called Transforaminal Epidural Steroid 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Lumbar Disc Herniation | 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. Receives: Drug: Transforaminal Epidural Injection | |
| Patients with Lumbar Spinal Stenosis | 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. Receives: Drug: Transforaminal Epidural Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale Leg Pain
The NRS score for leg pain
Measured: 2 weeks
Secondary outcomes (17)
Numerical Rating Scale Leg Pain
The NRS score for leg pain
Measured: 30 minutes after treatment
Numerical Rating Scale Leg Pain
The NRS score for leg pain
Measured: 6 weeks
Numerical Rating Scale Back Pain
The NRS score for back pain
Measured: 30 minutes after treatment
Numerical Rating Scale Back Pain
The NRS score for back pain
Measured: 2 weeks
Numerical Rating Scale Back Pain
The NRS score for back pain
Measured: 6 weeks
Oswestry Disability Index
The ODI score for functionality
Measured: 2 weeks
Oswestry Disability Index
The ODI score for functionality
Measured: 6 weeks
Global Perceived Effect
The degree of patient satisfaction from experienced recovery on a Likert scale
Measured: 2 weeks
Global Perceived Effect
The degree of patient satisfaction from experienced recovery on a Likert scale
Measured: 6 weeks
Hospital Anxiety and Depression Scale
The HADS score for assessment of anxiety and depression
Measured: 2 weeks
Hospital Anxiety and Depression Scale
The HADS score for assessment of anxiety and depression
Measured: 6 weeks
Pain Coping Inventory
Assessment of the pain coping mechanisms of the patient
Measured: 2 weeks
Pain Coping Inventory
Assessment of the pain coping mechanisms of the patient
Measured: 6 weeks
Visual Analogue Scale Quality of Life
The VAS for assessment of Quality of Life
Measured: 2 weeks
Visual Analogue Scale Quality of Life
The VAS for assessment of Quality of Life
Measured: 6 weeks
Use of pain medication and physical therapy
Use of pain medication and physical therapy
Measured: 2 weeks
Use of pain medication and physical therapy
Use of pain medication and physical therapy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start15 Nov 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eduard Verheijen
- Sponsor type
- University, hospital or other
- Collaborators
- Spaarne Gasthuis
- Responsible party
- Sponsor-investigator, Eduard Verheijen, Leiden University Medical Center
- Investigators
- Carmen LA Vleggeert-Lankamp, MD, PhD, Principal investigator, Leiden University Medical Centre / Spaarne Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540068
- Sponsor's protocol ID
- POTEISS
- Acronym
- POTEISS
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11887877Sencan 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.
PubMed 31742372Billy 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.
PubMed 27764056Lee 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.
PubMed 17114531McCormick 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.
PubMed 25108099Cyteval 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.
PubMed 16687527Verheijen EJA, van Haagen OBHAM, Bartels EC, van der Sloot K, van den Akker-van Marle ME, Steyerberg EW, Vleggeert-Lankamp CLA. Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis. BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.
PubMed 39164613
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Transforaminal Epidural Injection Success in Sciatica
- ClinicalTrials.gov ID
- NCT04540068
- Acronym / sponsor ID
- POTEISS / POTEISS
- Keywords
- Transforaminal Epidural Injection, Lumbar spine, Prospective cohort study, Prediction of success
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Eduard VerheijenUniversity, hospital or other
- Collaborators
- Spaarne Gasthuis
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ✓ ✓
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Lumbar Disc Herniation | – | Drug: Transforaminal Epidural InjectionPatients 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. |
| Patients with Lumbar Spinal Stenosis | – | Drug: Transforaminal Epidural InjectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transforaminal Epidural InjectionAlso: Transforaminal Epidural Steroid InjectionInjections 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. | Drug | Patients with Lumbar Disc Herniation, Patients with Lumbar Spinal Stenosis |
Primary outcome
Numerical Rating Scale Leg Pain
Time frame: 2 weeks
The NRS score for leg pain
17 secondary outcomes
Numerical Rating Scale Leg Pain
Time frame: 30 minutes after treatment
Numerical Rating Scale Leg Pain
Time frame: 6 weeks
Numerical Rating Scale Back Pain
Time frame: 30 minutes after treatment
Numerical Rating Scale Back Pain
Time frame: 2 weeks
Numerical Rating Scale Back Pain
Time frame: 6 weeks
Oswestry Disability Index
Time frame: 2 weeks
Oswestry Disability Index
Time frame: 6 weeks
Global Perceived Effect
Time frame: 2 weeks
Global Perceived Effect
Time frame: 6 weeks
Hospital Anxiety and Depression Scale
Time frame: 2 weeks
Hospital Anxiety and Depression Scale
Time frame: 6 weeks
Pain Coping Inventory
Time frame: 2 weeks
Pain Coping Inventory
Time frame: 6 weeks
Visual Analogue Scale Quality of Life
Time frame: 2 weeks
Visual Analogue Scale Quality of Life
Time frame: 6 weeks
Use of pain medication and physical therapy
Time frame: 2 weeks
Use of pain medication and physical therapy
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 11887877Vroomen 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.
- Background: PubMed 31742372Sencan 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.
- Background: PubMed 27764056Billy 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.
- Background: PubMed 17114531Lee 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.
- Background: PubMed 25108099McCormick 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.
- Background: PubMed 16687527Cyteval 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.
- Derived from this study: PubMed 39164613Verheijen EJA, van Haagen OBHAM, Bartels EC, van der Sloot K, van den Akker-van Marle ME, Steyerberg EW, Vleggeert-Lankamp CLA. Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis. BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen LA Vleggeert-Lankamp, MD, PhD principal investigator
Leiden University Medical Centre / Spaarne Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Radiculopathy and Lumbar Disc Herniation, run by Eduard Verheijen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduard JA Verheijen, MD (+3171526746, e.j.a.verheijen@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale Leg Pain (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540068, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.