POTEISS: Prediction of TEI Success in Sciatica

Sponsor

EJAVerheijen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04540068

Collaborator

Spaarne Gasthuis (Other)

388

Enrollment

Location

36.5

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Radiculopathy Lumbar Disc Herniation Lumbar Spinal Stenosis	Drug: Transforaminal Epidural Injection

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

Study Type:

Observational

Anticipated Enrollment :

388 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prediction Of Transforaminal Epidural Injection Success in Sciatica

Actual Study Start Date :

Nov 15, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Other Names: Transforaminal Epidural Steroid 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.	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. Other Names: Transforaminal Epidural Steroid Injection

Arm

Intervention/Treatment

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.

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.

Other Names:

Transforaminal Epidural Steroid 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.

Drug: Transforaminal Epidural Injection

Other Names:

Transforaminal Epidural Steroid Injection

Outcome Measures

Primary Outcome Measures

Numerical Rating Scale Leg Pain [2 weeks]
The NRS score for leg pain

Secondary Outcome Measures

Numerical Rating Scale Leg Pain [30 minutes after treatment]
The NRS score for leg pain
Numerical Rating Scale Leg Pain [6 weeks]
The NRS score for leg pain
Numerical Rating Scale Back Pain [30 minutes after treatment]
The NRS score for back pain
Numerical Rating Scale Back Pain [2 weeks]
The NRS score for back pain
Numerical Rating Scale Back Pain [6 weeks]
The NRS score for back pain
Oswestry Disability Index [2 weeks]
The ODI score for functionality
Oswestry Disability Index [6 weeks]
The ODI score for functionality
Global Perceived Effect [2 weeks]
The degree of patient satisfaction from experienced recovery on a Likert scale
Global Perceived Effect [6 weeks]
The degree of patient satisfaction from experienced recovery on a Likert scale
Hospital Anxiety and Depression Scale [2 weeks]
The HADS score for assessment of anxiety and depression
Hospital Anxiety and Depression Scale [6 weeks]
The HADS score for assessment of anxiety and depression
Pain Coping Inventory [2 weeks]
Assessment of the pain coping mechanisms of the patient
Pain Coping Inventory [6 weeks]
Assessment of the pain coping mechanisms of the patient
Visual Analogue Scale Quality of Life [2 weeks]
The VAS for assessment of Quality of Life
Visual Analogue Scale Quality of Life [6 weeks]
The VAS for assessment of Quality of Life
Use of pain medication and physical therapy [2 weeks]
Use of pain medication and physical therapy
Use of pain medication and physical therapy [6 weeks]
Use of pain medication and physical therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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