Prediction of TEI Success in Sciatica
- Conditions
- Lumbar RadiculopathyLumbar Disc HerniationLumbar Spinal Stenosis
- Interventions
- Drug: Transforaminal Epidural Injection
- Registration Number
- NCT04540068
- Lead Sponsor
- Eduard Verheijen
- Brief 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 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 ✓ ✓
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 388
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Lumbar Spinal Stenosis 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. Patients with Lumbar Disc Herniation Transforaminal Epidural Injection 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.
- Primary Outcome Measures
Name Time Method Numerical Rating Scale Leg Pain 2 weeks The NRS score for leg pain
- Secondary Outcome Measures
Name Time Method Numerical Rating Scale Leg Pain 6 weeks The NRS score for leg pain
Numerical Rating Scale Back Pain 6 weeks The NRS score for back pain
Oswestry Disability Index 6 weeks The ODI score for functionality
Global Perceived Effect 6 weeks The degree of patient satisfaction from experienced recovery on a Likert scale
Hospital Anxiety and Depression Scale 6 weeks The HADS score for assessment of anxiety and depression
Pain Coping Inventory 6 weeks Assessment of the pain coping mechanisms of the patient
Visual Analogue Scale Quality of Life 6 weeks The VAS for assessment of Quality of Life
Use of pain medication and physical therapy 6 weeks Use of pain medication and physical therapy
Trial Locations
- Locations (1)
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands