Spaarne Gasthuis
Haarlem, Netherlands
Location status: Recruiting
Location contact
Carmen Vleggeert-Lankamp, M.D. Ph.D
CONTACT
Recruiting
NCT Number: NCT04540068
Prediction of TEI 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:
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Lumbar Radiculopathy
Bone Diseases
Hernia
Intervertebral Disc Displacement
Lumbar Disc Herniation
Lumbar Spinal Stenosis
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathological Conditions, Anatomical
Pathological Conditions, Signs and Symptoms
Peripheral Nervous System Diseases
Radiculopathy
Spinal Diseases
Spinal Stenosis
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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 ✓ ✓
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Transforaminal Epidural Injection
DrugInjections 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.
Other names: Transforaminal Epidural Steroid Injection
Primary outcomes
-
Numerical Rating Scale Leg Pain
Time frame: 2 weeks
The NRS score for leg pain
Secondary outcomes
-
Numerical Rating Scale Leg Pain
Time frame: 30 minutes after treatment
The NRS score for leg pain
-
Numerical Rating Scale Leg Pain
Time frame: 6 weeks
The NRS score for leg pain
-
Numerical Rating Scale Back Pain
Time frame: 30 minutes after treatment
The NRS score for back pain
-
Numerical Rating Scale Back Pain
Time frame: 2 weeks
The NRS score for back pain
-
Numerical Rating Scale Back Pain
Time frame: 6 weeks
The NRS score for back pain
-
Oswestry Disability Index
Time frame: 2 weeks
The ODI score for functionality
-
Oswestry Disability Index
Time frame: 6 weeks
The ODI score for functionality
-
Global Perceived Effect
Time frame: 2 weeks
The degree of patient satisfaction from experienced recovery on a Likert scale
-
Global Perceived Effect
Time frame: 6 weeks
The degree of patient satisfaction from experienced recovery on a Likert scale
-
Hospital Anxiety and Depression Scale
Time frame: 2 weeks
The HADS score for assessment of anxiety and depression
-
Hospital Anxiety and Depression Scale
Time frame: 6 weeks
The HADS score for assessment of anxiety and depression
-
Pain Coping Inventory
Time frame: 2 weeks
Assessment of the pain coping mechanisms of the patient
-
Pain Coping Inventory
Time frame: 6 weeks
Assessment of the pain coping mechanisms of the patient
-
Visual Analogue Scale Quality of Life
Time frame: 2 weeks
The VAS for assessment of Quality of Life
-
Visual Analogue Scale Quality of Life
Time frame: 6 weeks
The VAS for assessment of Quality of Life
-
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
Use of pain medication and physical therapy
Study contacts
Contact information is provided by the study sponsor or research team.
Carmen LA Vleggeert-Lankamp, MD, PhD
CONTACT
Eduard JA Verheijen, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Eduard Verheijen
Other
Collaborators
- Spaarne Gasthuis
Registry information
Official study title
Prediction of Transforaminal Epidural Injection Success in Sciatica
Acronym: POTEISS
Important dates
- Study start
- 2020
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 7, 2020
- Registry last updated
- Mar 12, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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