Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis.
Humans
Injections, Epidural
/ methods
Intervertebral Disc Displacement
/ complications
Spinal Stenosis
/ complications
Sciatica
/ drug therapy
Treatment Outcome
Prospective Studies
Lumbar Vertebrae
Male
Female
Radiculopathy
/ drug therapy
Steroids
/ administration & dosage
Adult
Middle Aged
Cohort Studies
Netherlands
/ epidemiology
Cost-effectiveness
Lumbar disc herniation
Lumbar radicular pain
Lumbar spine
Prediction model
Spinal stenosis
Transforaminal epidural steroid injection
Journal
BMC neurology
ISSN: 1471-2377
Titre abrégé: BMC Neurol
Pays: England
ID NLM: 100968555
Informations de publication
Date de publication:
20 Aug 2024
20 Aug 2024
Historique:
received:
05
10
2023
accepted:
12
08
2024
medline:
21
8
2024
pubmed:
21
8
2024
entrez:
20
8
2024
Statut:
epublish
Résumé
Transforaminal epidural injections (TEI) can alleviate symptoms and help to maintain physical functioning and quality of life in patients with lumbar radicular pain. We aim to develop a prediction model for patient outcome after TEI in patients suffering from unilateral lumbar radicular pain due to lumbar disc herniation (LDH) or single-level spinal stenosis (LSS). The secondary aim is to estimate short-term patient outcome differences between LDH and LSS patients, the association between psychological variables and patient outcome, the rate of additional injections, surgery and complications, and to explore the short-term cost-effectiveness of TEI. This study is designed as a multi-centre, observational, prospective cohort study in two large regional hospitals in the Netherlands. Patients diagnosed with unilateral lumbar radicular pain secondary to LDH or LSS and congruent with MRI findings, who are referred for TEI along usual care pathways, are eligible for study participation. A total of 388 patients with LDH or LSS will be included. A pre-defined set of demographic, clinical and radiological variables will be used as the predictors in the model. The primary outcome measure is the Numerical Rating Scale (NRS) for leg pain. Secondary outcome measures include back pain, physical functioning, perceived recovery, pain coping strategies, anxiety and depression and use of analgesics and physical therapy. Patients will be evaluated at baseline, 2 weeks and 6 weeks after treatment. NRS leg pain and Likert perceived recovery data will be used as the dependent variables in a generalized linear mixed model for prediction of TEI outcome, with internal validation of performance (explained variation) by bootstrap resampling. Cost-effectiveness for a period of 6 weeks prior to and after treatment will be performed with decision-analytic modelling. Patients with severe lumbar radicular pain often request additional treatment when conservative care is insufficient. TEI can offer relief of symptoms. Currently, it is not possible to predict responsiveness to this treatment for individual patients. This study is designed to explore predictors that can differentiate between patients that will and will not have a positive outcome after TEI. This information may support treatment strategies for this patient group. This study is registered at ClinicalTrials.gov database under registry number NCT04540068 on September 1, 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Transforaminal epidural injections (TEI) can alleviate symptoms and help to maintain physical functioning and quality of life in patients with lumbar radicular pain. We aim to develop a prediction model for patient outcome after TEI in patients suffering from unilateral lumbar radicular pain due to lumbar disc herniation (LDH) or single-level spinal stenosis (LSS). The secondary aim is to estimate short-term patient outcome differences between LDH and LSS patients, the association between psychological variables and patient outcome, the rate of additional injections, surgery and complications, and to explore the short-term cost-effectiveness of TEI.
METHODS
METHODS
This study is designed as a multi-centre, observational, prospective cohort study in two large regional hospitals in the Netherlands. Patients diagnosed with unilateral lumbar radicular pain secondary to LDH or LSS and congruent with MRI findings, who are referred for TEI along usual care pathways, are eligible for study participation. A total of 388 patients with LDH or LSS will be included. A pre-defined set of demographic, clinical and radiological variables will be used as the predictors in the model. The primary outcome measure is the Numerical Rating Scale (NRS) for leg pain. Secondary outcome measures include back pain, physical functioning, perceived recovery, pain coping strategies, anxiety and depression and use of analgesics and physical therapy. Patients will be evaluated at baseline, 2 weeks and 6 weeks after treatment. NRS leg pain and Likert perceived recovery data will be used as the dependent variables in a generalized linear mixed model for prediction of TEI outcome, with internal validation of performance (explained variation) by bootstrap resampling. Cost-effectiveness for a period of 6 weeks prior to and after treatment will be performed with decision-analytic modelling.
DISCUSSION
CONCLUSIONS
Patients with severe lumbar radicular pain often request additional treatment when conservative care is insufficient. TEI can offer relief of symptoms. Currently, it is not possible to predict responsiveness to this treatment for individual patients. This study is designed to explore predictors that can differentiate between patients that will and will not have a positive outcome after TEI. This information may support treatment strategies for this patient group.
TRIAL REGISTRATION
BACKGROUND
This study is registered at ClinicalTrials.gov database under registry number NCT04540068 on September 1, 2020.
Identifiants
pubmed: 39164613
doi: 10.1186/s12883-024-03801-1
pii: 10.1186/s12883-024-03801-1
doi:
Substances chimiques
Steroids
0
Banques de données
ClinicalTrials.gov
['NCT04540068']
Types de publication
Journal Article
Observational Study
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
290Informations de copyright
© 2024. The Author(s).
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