Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT04540068
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 ✓ ✓
Study:
NCT04540068
Study Brief:
Protocol Section:
NCT04540068