Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol
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 l...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e077776.full |
| _version_ | 1797429288014708736 |
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| author | Richard D Riley Nadine E Foster Andrea Cherrington Siobhan Stynes Kym IE Snell Kika Konstantinou Noor Daud Raymond Ostelo John O'Dowd |
| author_facet | Richard D Riley Nadine E Foster Andrea Cherrington Siobhan Stynes Kym IE Snell Kika Konstantinou Noor Daud Raymond Ostelo John O'Dowd |
| author_sort | Richard D Riley |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T09:11:00Z |
| format | Article |
| id | doaj.art-75a763ce6a994b44b4f71075b39cb87f |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T09:11:00Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-75a763ce6a994b44b4f71075b39cb87f2023-12-02T08:40:08ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2023-077776Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocolRichard D Riley0Nadine E Foster1Andrea Cherrington2Siobhan Stynes3Kym IE Snell4Kika Konstantinou5Noor Daud6Raymond Ostelo7John O'Dowd8College of Medical and Dental Sciences, University of Birmingham Institute of Applied Health Research, Birmingham, UKSchool of Medicine, Keele University, Keele, Staffordshire, UKSchool of Medicine, Keele University, Keele, Staffordshire, UKSchool of Medicine, Keele University, Keele, Staffordshire, UKCollege of Medical and Dental Sciences, University of Birmingham Institute of Applied Health Research, Birmingham, UKSchool of Medicine, Keele University, Keele, Staffordshire, UKSchool of Medicine, Keele University, Keele, Staffordshire, UKDepartment of Health Sciences, VU Amsterdam Faculty of Sciences, Amsterdam, The NetherlandsHampshire Hospitals NHS Foundation Trust, Hampshire, UKIntroduction 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.https://bmjopen.bmj.com/content/13/11/e077776.full |
| spellingShingle | Richard D Riley Nadine E Foster Andrea Cherrington Siobhan Stynes Kym IE Snell Kika Konstantinou Noor Daud Raymond Ostelo John O'Dowd Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol BMJ Open |
| title | Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol |
| title_full | Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol |
| title_fullStr | Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol |
| title_full_unstemmed | Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol |
| title_short | Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol |
| title_sort | predictors of outcome in sciatica patients following an epidural steroid injection the poise prospective observational cohort study protocol |
| url | https://bmjopen.bmj.com/content/13/11/e077776.full |
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