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The Incidence of Various Types of Systemic Reactions Related to Epidural Steroid Injections: A Prospective Observational Study.

ABSTRACT: Objective:To evaluate the incidence, types and association of systemic reactions after an epidural steroid injection (ESI) with patient demographics, ESI factors and repeated occurrence of an ESI. Materials and Methods:This prospective observational study was approved by the Institutional Review Board of our hospital, and written informed consent was obtained from all the participants. From October to December 2011, systemic reactions at 2 weeks after 960 ESIs among 885 patients were measured. Patients were evaluated by phone interviews to obtain the patients' demographics, history of previous ESI, ESI factors, and ESI reoccurrence. Statistical analyses were performed using the chi-square tests, Fisher's exact tests and a binary logistic regression analysis. Results:Overall, 557 types of systemic reactions occurred after 292 injections (30.4%) of a total of 960 ESIs in which facial flushing was most common (131/557, 23.5%) and 144 ESIs were followed by a mixed form of systemic reactions (49.3%). Age of 62 years or younger (odds ratio [OR], 2.361), female sex (OR, 1.674), and history of diabetes mellitus (OR, 1.681) were significant risk factors in the occurrence of systemic reactions after an ESI. In 73 patients with repeated ESI, 14 patients re-experienced systemic reactions (19.2%), of which twelve re-experienced the same systemic reaction as the previous one. Conclusion:Systemic reactions followed about 30% of ESIs, and more commonly occurred in patients 62 years of age or younger, women, and diabetic patients. Half of the patients experienced a mixed form of systemic reactions. Patients with recurring systemic reactions tend to re-experience the same systemic reaction as the prior one after an ESI.

SUBMITTER: Lee GY

PROVIDER: S-EPMC5840059 | biostudies-literature | 2018 Mar-Apr

REPOSITORIES: biostudies-literature

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The Incidence of Various Types of Systemic Reactions Related to Epidural Steroid Injections: A Prospective Observational Study.

Lee Guen Young GY Lee Joon Woo JW Yeom Jin S JS Kim Ki-Jeong KJ Shin Hyung-Ik HI Kang Heung Sik HS

Korean journal of radiology 20180222 2

<h4>Objective</h4>To evaluate the incidence, types and association of systemic reactions after an epidural steroid injection (ESI) with patient demographics, ESI factors and repeated occurrence of an ESI.<h4>Materials and methods</h4>This prospective observational study was approved by the Institutional Review Board of our hospital, and written informed consent was obtained from all the participants. From October to December 2011, systemic reactions at 2 weeks after 960 ESIs among 885 patients w ...[more]

PMID: 29520188

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Project description:BackgroundLumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.MethodsWe will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.DiscussionThis study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.Trial registrationClinicaltrials.gov NCT01238536.

Project description:ObjectiveTo evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy.DesignA multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes.SettingsEight military, Veterans Administration, and civilian hospitals.Participants145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain.InterventionsParticipants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin.Main outcome measuresAverage leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥ 2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit.ResultsThere were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments.ConclusionsAlthough epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier: NCT01495923.

Dataset Information

The Incidence of Various Types of Systemic Reactions Related to Epidural Steroid Injections: A Prospective Observational Study.

Publications

The Incidence of Various Types of Systemic Reactions Related to Epidural Steroid Injections: A Prospective Observational Study.

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