Prediction of TEI Success in Sciatica (POTEISS)

Eduard Verheijen

Status: Enrolling

Conditions: Lumbar Spinal Stenosis; Lumbar Radiculopathy; Lumbar Disc Herniation

Treatments: Drug: Transforaminal Epidural Injection

Study type: Observational

Funder types: Other

Identifiers

NCT04540068

POTEISS

Details and patient eligibility

About

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.

Full 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 ✓ ✓

Enrollment: 388 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

388 participants in 2 patient groups

Patients with Lumbar Disc Herniation

Description:

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.

Treatment:

Drug: Transforaminal Epidural Injection

Patients with Lumbar Spinal Stenosis

Description:

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.

Treatment:

Drug: Transforaminal Epidural Injection