Cost-effectiveness of Transforaminal epidural steroid injections for patients with ACUTE sciatica: a randomized controlled trial.

BACKGROUND: Transforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness of TESI in patients with acute sciatica (< 8 weeks). This article contains the economic evaluation of the STAR-trial. METHODS: Participants were randomized to one of three study arms: Usual Care (UC), that is oral pain medication with or without physiotherapy, n = 45); intervention group 1: UC and transforaminal epidural steroid injection (TESI) 1 ml of 0.5% Levobupivacaine and 1 ml of 40 mg/ml Methylprednisolone and intervention group 2: UC and transforaminal epidural injection (TEI) with 1 ml of 0,5% Levobupivacaine and 1 ml of 0.9% NaCl (n = 50). The primary effect measure was health-related quality of life. Secondary outcomes were pain, functioning, and recovery. Costs were measured from a societal perspective, meaning that all costs were included, irrespective of who paid or benefited. Missing data were imputed using multiple imputation, and bootstrapping was used to estimate statistical uncertainty. RESULTS: None of the between-group differences in effects were statistically significant for any of the outcomes (QALY, back pain, leg pain, functioning, and global perceived effect) at the 26-weeks follow-up. The adjusted mean difference in total societal costs was €1718 (95% confidence interval [CI]: - 3020 to 6052) for comparison 1 (intervention group 1 versus usual care), €1640 (95%CI: - 3354 to 6106) for comparison 2 (intervention group 1 versus intervention group 2), and €770 (95%CI: - 3758 to 5702) for comparison 3 (intervention group 2 versus usual care). Except for the intervention costs, none of the aggregate and disaggregate cost differences were statistically significant. The maximum probability of all interventions being cost-effective compared to the control was low (< 0.7) for all effect measures. CONCLUSION: These results suggest that adding TESI (or TEI) to usual care is not cost-effective compared to usual care in patients with acute sciatica (< 8 weeks) from a societal perspective in a Dutch healthcare setting. TRIAL REGISTRATION: Dutch National trial register: NTR4457 (March, 6th, 2014).

Transforaminal epidural steroid injection for radiculopathy and the evolution to surgical treatment: a pragmatic prospective observational multicenter study.

Aim: The aim of this study is to analyze the real-world outcomes of transforaminal epidural steroid injections (TFESIs) in all patients with radiculopathy and their long-term outcomes. Methods: Patients with radiculopathy and failure of conservative treatment were included in a prospective, multicenter, observational cohort study. Results: In total, 117 patients were treated with one or two TFESIs. The mean duration of follow-up was 116 (±14) weeks. In total 19,6% (95% CI: 12.9-28.0%) patients were treated with surgery after insufficient symptom improvement. The evolution to surgery was not associated with etiology, symptom duration or previous spine surgery. Conclusion: Real-world data confirms that TFESIs is an effective treatment with satisfactory results in about 80% of patients for a period of 2 years.

This study focusses on evaluating the real-world effectiveness of transforaminal epidural steroid injections (TFESIs) in treating radiculopathy, a condition characterized by back and leg pain due to compressed spinal nerves. This nerve compression can originate from different problems.A total of 117 patients with radiating leg pain were included in this study. The infiltrations were administered, and the primary outcome was the need for spinal surgery within 2 years. The findings revealed that approximately 20% of patients eventually required surgery due to unsatisfactory results after injections. However, for patients with satisfactory outcomes, there was a notable reduction in back and leg pain, disability and pain medication usage, along with an improved quality of life.Importantly, the results suggested that TFESIs could be considered as a treatment option in daily clinical practice, also after a prolonged duration of symptoms.Despite certain limitations, such as the absence of a control group undergoing immediate surgical treatment, the real-world data supported the effectiveness of TFESIs in treating radiculopathy. This information provides valuable insights for spine surgeons and pain physicians in understanding the prognosis of TFESIs across diverse patient scenarios.

Neuropsychiatric Side Effects After Lumbosacral Epidural Steroid Injections: A Prospective Cohort Study.

BACKGROUND: The central nervous system contains steroid receptors, particularly in the hypothalamic and limbic systems. These systems are responsible for driving certain emotions in humans, especially stress, anxiety, motivation, energy levels, and mood. Thus, corticosteroids may precipitate patients to experience these emotions. Most existing studies report neuropsychiatric side effects after oral or intravenous corticosteroids rather than epidural. OBJECTIVES: This study examines the neuropsychiatric side effects after epidural steroid injections (ESIs), with a focus on whether certain factors in patients' histories further exacerbate symptomatology. STUDY DESIGN: Prospective observational cohort study. SETTING: Fluoroscopy suite at an urban academic teaching hospital. METHODS: Patients were called 24 hours and one week after their ESIs and asked if they experienced certain neuropsychiatric symptoms more than usual compared to baseline. PATIENTS: Seventy-four patients undergoing a lumbosacral ESI (interlaminar (ILESI), caudal or transforaminal (TFESI)) were invited to take part in the study the day of his or her procedure. INTERVENTION/MEASUREMENT: Assessed whether psychiatric history, gender, race, type of ESI, or the number of levels injected affected frequency and duration of neuropsychiatric symptoms at one day and one week after an ESI. RESULTS: Significantly (P < 0.05) more patients with a psychiatric history experienced restlessness and irritability at day one than those without a psychiatric history. At week one, male gender (IRR 2.29, 95% CI 1.37, 3.83, P = 0.002), ILESI (IRR 7.75, 95% CI 1.03, 58.6, P = 0.047), and 2-level injections (IRR 2.14, 95% CI 1.13, 4.06, P = 0.019) were significantly associated to more total symptoms. LIMITATIONS: Single center study, reliance on subjective responses from patients, lack of follow-up after one week post-ESI. CONCLUSION(S): This study demonstrates that neuropsychiatric symptoms are rare overall after an ESI, though certain factors may influence patients experiencing these symptoms. Restlessness and irritability were more likely to occur one day after an ESI in those with a psychiatric history. Those who had a 2-level injection were more likely to keep experiencing most symptoms by week one, suggesting a possible correlation between corticosteroid dose and neuropsychiatric symptoms.

A Change in Global Sagittal Alignment after Transforaminal Epidural Steroid Injections in Lumbar Spinal Stenosis.

Patients' functional adaptation to pain can affect global sagittal alignment. This study evaluated the short-term spinal sagittal alignment change after transforaminal epidural steroid injection (TFESI) in lumbar spinal stenosis patients. Patients with lumbar spinal stenosis who underwent TFESI were retrospectively examined. Clinical outcomes were assessed using the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI). Before and two weeks after the intervention, whole-spine lateral standing view radiographs were taken. Radiographic parameters including the Sagittal Vertical Axis (SVA), C2C7 Cobb, Thoracic Kyphosis (TK), Lumbar Lordosis (LL), Pelvic Incidence (PI), Pelvic Tilt (PT), Sacral Slope (SS), and Lumbopelvic Mismatch (PI-LL) were measured. Ninety-nine patients (mean age 64.3 ± 9.2 years) were included in this study. Both VAS and ODI outcomes were statistically improved after two weeks of intervention. Radiographic parameters showed that SVA, PT, and PI-LL mismatch were significantly decreased, while C2C7 Cobb, TK, SS, and LL were significantly increased after the intervention. SVA was improved by 29.81% (52.76 ± 52.22 mm to 37.03 ± 41.07 mm, p < 0.001). PT also decreased significantly from 28.71° ± 10.22° to 23.84° ± 9.96° (p < 0.001). Transforaminal epidural steroid injection (TFESI) significantly improves VAS, ODI, and global sagittal parameters in lumbar spinal stenosis patients.

Transforaminal epidural steroid injection can result in further neurological injury in a patient with severe foraminal stenosis and nerve impingement.

BACKGROUND: Chronic low back pain (LBP) is highly prevalent and costly in our society. The use of epidural steroid injections (ESIs) for the treatment of radicular LBP is very widespread and continues to rise. The most popular injection is the lumbar/sacral transforaminal epidural steroid injection (TFESI). Here, we present a serious neurological complication resulting from such a TFESI that was only reversed by timely neurosurgical intervention. CASE DESCRIPTION: A 49-year-old male presented with a 5-year history of progressive neurogenic claudication and right lower extremity pain/radiculopathy. He had previously received multiple lumbar ESIs and other conservative therapy. Due to a recent exacerbation of his radiculopathy associated with MRI-documented lumbosacral spondylosis, he underwent a right L5/S1 TFESI under fluoroscopic guidance. This resulted in acute right lower extremity weakness accompanied by a right-sided foot drop and sphincter dysfunction. Although the follow-up MRI was noncontributory, the EMG showed L5/S1 denervation, and the patient underwent an L4-5, L5-S1 laminectomy with discectomies at the L4-5 and L5-S1 levels. Immediately after the surgery, the patient's weakness and sensory deficits improved. Two years later, the patient continued to do well without evidence of recurrence of signs or symptoms of lumbosacral radiculopathy. CONCLUSION: Patients should be counseled about the risk and benefits of TFESI. Surgical treatment may be warranted in patients who develop acutely progressive worsening following these non-FDA (Food/Drug Administration) approved injections.

A minimum of 5-year follow-up after lumbar transforaminal epidural steroid injections in patients with lumbar radicular pain due to intervertebral disc herniation.

BACKGROUND CONTEXT: Patients with lumbosacral radiculopathy from an intervertebral disc herniation are frequently treated by transforaminal epidural steroid injections (TFESIs). The long-term outcomes of these patients are poorly described. PURPOSE: We aimed to determine the long-term outcomes for a homogenous group of patients with acute unilateral lumbar radicular pain due to single-level herniated nucleus after lumbar epidural steroid injection at ≥5 years. DESIGN: This is a prospective cohort study. PATIENT SAMPLE: Subjects enrolled into a previous reported multi-institutional randomized controlled trial, ≥18 years old with single leg radicular pain rating ≥4/10 for less than 6 months' duration, with radiographic imaging demonstrating an anatomically congruent single-level herniated nucleus pulposus. OUTCOME MEASURES: Presence of recurrent or persistent pain, pain within the previous week, current opioid use for radicular symptoms, additional spine injections for radicular pain, progression to surgery, and unemployment due to pain as determined by independent phone interview at least 5 years after enrolment due to the initial pain complaint were the outcome measures. METHODS: All patients initially underwent a single-level lumbar TFESIs due to failure of conservative care, but could elect to pursue surgical intervention or repeat injections through shared decision making with the treating physician when and if pain control was deemed inadequate. After ≥5 years, an independent assessor contacted the subjects by phone and performed a standardized interview to determine outcomes. Fisher exact test was used to compare outcomes for those who pursued versus those who did not pursue surgery. RESULTS: During the recruitment period (December 2008 to December 2012), 78 subjects were enrolled. At 5 years, 39 (50%) of the 78 subjects were reachable for independent phone follow-up. Of these, 30 (76.9%, 95% confidence interval [CI] 61.7%-87.4%) had a history of recurrent pain since the initial TFESI. However, only 9 (23.1%, 95% CI 12.7%-38.3%) had current pain, while 3 (7.7%, 95% CI 2.7%-20.3%) were currently taking opioid medications. Nine (23.1%, 95% CI 12.7%-38.3%) had received additional TFESIs, and 19 (48.7%, 95% CI 33.9%-63.8%) had received surgery. Only 3 (7.7%, 95% CI 2.7%-20.3%) were unemployed due to related pain at time of follow-up. When comparing the group that had surgery versus those that did not, there were no differences in the rates of recurrent pain (16, 84.2% vs. 14, 70.0%, p=.81), current pain (6, 31.6% vs. 3, 15.0%, p=.47), opioid use (2, 10.5% vs. 1, 5.0%, p=1.00), rate of additional injections (6, 31.6% vs. 3, 15.0%, p=.47), or unemployment status (2, 10.5% vs. 1, 5.0%, p=1.00). CONCLUSIONS: Despite a high success rate at 6 months, the majority of subjects experienced a recurrence of symptoms at some time during the subsequent 5 years. Fortunately, few reported current symptoms, and a small minority required additional injections, surgery, or opioid pain medications. Lumbar disc herniation is a disease that can be effectively treated in the short-term by TFESI or surgery, but long-term recurrence rates are high regardless of treatment received.

Comparison of lumbosacral transforaminal epidural steroid injection techniques in terms of radiation safety.

AIM: To investigate the difference in radiation exposure to the patients between oblique and posteroanterior view, initial approach techniques in fluoroscopy-guided lumbosacral transforaminal epidural steroid injections. PATIENTS & METHODS: Total amount of Kerma area product, elapsed time of the procedure and fluoroscopy time were obtained from medical records retrospectively. RESULTS: 28 patients were included in each group. Fluoroscopy time was significantly lower in group 1, but there was no statistically significant difference in terms of procedure time and Kerma area product. CONCLUSION: Radiation risk does not change between these approaches.

Efficacy of Transforaminal Epidural Steroid Injections According to Nerve Root Enhancement

OBJECTIVE: To determine the efficacy of transforaminal epidural steroid injections according to nerve root enhancement in lumbar disc herniations. METHOD: Twenty seven patients who had extruded or seques tered lumbar disc herniations on enhanced MR imaging were investigated: fifteen patients with corresponding nerve root enhancement (enhanced group), and twelve patients without enhancement (non-enhanced group). All patients received transforaminal epidural steroid injection. Clinical outcomes were measured by visual analogue scale (VAS) for back and radicular pain, Oswestry disability index (ODI) before treatment and one month after injection. RESULTS: The averages of VAS for lower extremity and back pain in both groups one month after injection significantly reduced compared to that of pretreatment, respectively (p<0.001). The amount of decrease in pain in enhanced group was larger than that of non-enhanced group (p<0.05). The averages of ODI in both group one month after injection significantly reduced compared to that of pretreatment (p<0.0001), however, there was no difference between the two groups. CONCLUSION: The nerve root enhancement on contrast-enhanced MR imaging indicates the presence of severe inflammatory reaction of nerve root, which means well-responsiveness to anti-inflammatory treatment such as transforaminal epidural steroid injection, even if patients' symptom is very severe.

An Analysis of the Outcome of Transforaminal Epidural Steroid Injections in Patients with Spinal Stenosis or Herniated Intervertebral Discs / 대한통증학회지

BACKGROUND: Spinal stenosis and herniated intervertebral discs are the principal causes of lumbosacral radiculopathy. This study was conducted to compare the therapeutic value and duration of pain relief of fluoroscopic guided transforaminal epidural steroid injections (TFESIs) in patients with refractory radicular leg pain. METHODS: Between August 2006 and March 2007, 87 patients (H group: patients with herniated intervertebral disc, S group: patients with spinal stenosis) who met the inclusion criteria were treated with fluoroscopic guided TFESIs. Prior to treatment, the VAS and ODI scores were determine to evaluate the degree of pain and level of disability. The degree of pain relief was then assessed 1 month after treatment with the TFESIs and graded as excellent (no residual pain), good (improvement of pain symptoms by more than 50%), fair (improvement of pain symptoms by less than 50%) and Poor (no improvement of pain). In addition, the duration of pain relief was evaluated by regular outpatient visits for 6 months, and by telephone interviews after 6 months. RESULTS: The H and S group both had excellet results at 1 month after treatment with TFESIs showing improvements of 44.1% and 20.8% respectively. However this difference was not significant between groups. In addition, a duration of pain relief greater than 6 months was achieved in 32.4% of the patients in the H group and 37.7% of those in the S group. CONCLUSIONS: TFESIs had a similar degree of therapeutic effectiveness and duration of pain relief in patients with spinal stenosis and herniated intervertebral discs.

Factors associated with the outcome of transforaminal epidural steroid injections / 대한마취과학회지

BACKGROUND: This study was undertaken to assaythe effectiveness of transforaminal epidural steroid injections (TFESIs) for sciatica and to identify potential predictors related to treatment outcome. METHODS: TFESIs were performed in 150 patients between August 2006 and March 2007. Seventy-five patients (35 women, 40 men; mean age, 59.1 years), who met the inclusion criteria, were studied. Therapeutic effects were evaluated twoweeks after injection. The following potential outcome predictors analyzed were as follows: one level vs. two level injection, Beck depression inventory score (20), Beck anxiety inventory score (16), cause of radiculopathy (spinal stenosis vs. herniated disk), gender, duration of radiculopathy (6 months), and Oswestry disability index score (60). The relationships between possible outcome predictors and therapeutic effects were evaluated. RESULTS: Forty-nine of the 75 patients (65.3%) had a satisfactory result two weeks after TFESIs. Of these, twenty-four of the 46 patients (52.2%) were treated by a one level injection and 25 (89.3%) of the 29 patients were treated by a two level injection. This outcome was statistically significant (P < 0.01). None of the other potential outcome predictors showed any statistical difference. CONCLUSIONS: TFESI is recommended as an effective method of managing radiculopathy. Two-level injectionsmay result in a better outcome than a one-level injection.