Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol

Siobhan Stynes, Kym Ie Snell, Richard D. Riley, Kika Konstantinou, Andrea Cherrington, Noor Daud, Raymond Ostelo, John O'Dowd, Nadine E. Foster

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

INTRODUCTION: Sciatica can be very painful and, in most cases, is due to pressure on a spinal nerve root from a disc herniation with associated inflammation. For some patients, the pain persists, and one management option is a spinal epidural steroid injection (ESI). The aim of an ESI is to relieve leg pain, improve function and reduce the need for surgery. ESIs work well in some patients but not in others, but we cannot identify these patient subgroups currently. This study aims to identify factors, including patient characteristics, clinical examination and imaging findings, that help in predicting who does well and who does not after an ESI. The overall objective is to develop a prognostic model to support individualised patient and clinical decision-making regarding ESI. METHODS: POiSE is a prospective cohort study of 439 patients with sciatica referred by their clinician for an ESI. Participants will receive weekly text messages until 12 weeks following their ESIand then again at 24 weeks following their ESI to collect data on leg pain severity. Questionnaires will be sent to participants at baseline, 6, 12 and 24 weeks after their ESI to collect data on pain, disability, recovery and additional interventions. The prognosis for the cohort will be described. The primary outcome measure for the prognostic model is leg pain at 6 weeks. Prognostic models will also be developed for secondary outcomes of disability and recovery at 6 weeks and additional interventions at 24 weeks following ESI. Statistical analyses will include multivariable linear and logistic regression with mixed effects model. ETHICS AND DISSEMINATION: The POiSE study has received ethical approval (South Central Berkshire B Research Ethics Committee 21/SC/0257). Dissemination will be guided by our patient and public engagement group and will include scientific publications, conference presentations and social media.

Original languageEnglish
Article numbere077776
Pages (from-to)1-9
Number of pages9
JournalBMJ Open
Volume13
Issue number11
Early online date19 Nov 2023
DOIs
Publication statusPublished - Nov 2023

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Funding

SS conceived the study. NEF, RDR, KK, RO and JO’D helped SS shape the fellowship application to secure funding for the POiSE study. SS led the design of the study with the support of her mentorship team NEF, KK, RDR, KS, RO and JO’D. RDR and KS prepared the analysis plan. ND and SS will perform the analysis, supported by KS. AC and SS are responsible for project management and coordination activities of the study and ND is contributing to data monitoring and reporting. SS prepared the draft of the manuscript which all authors critically reviewed and approved the final version.

FundersFunder number
Health Education England
National Institute for Health and Care ResearchNIHR300441

    Keywords

    • Back pain
    • EPIDEMIOLOGY
    • PAIN MANAGEMENT
    • Patients
    • Prognosis
    • Spine

    Fingerprint

    Dive into the research topics of 'Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol'. Together they form a unique fingerprint.

    Cite this