Condition: Lumbar Radiculopathy · Lumbar Disc Herniation · Lumbar Spinal Stenosis · Sponsor: Eduard Verheijen
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 healthcar…
This description comes directly from the study's public registry record.
Eduard JA Verheijen, MD · +3171526746 · e.j.a.verheijen@lumc.nl
Carmen LA Vleggeert-Lankamp, MD, PhD · +31715262093 · c.l.a.vleggeert-lankamp@lumc.nl
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| Spaarne Gasthuis | Haarlem, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04540068