Caudal Epidural Injection Research Articles

Randomized Trial of Epidural Injections for Spinal Stenosis Published in The New England Journal of Medicine: Further Confusion Without Clarification

Randomized controlled trials are considered the hallmark of evidence-based medicine. This conveys the idea that up-to-date evidence applied consistently in clinical practice, in combination with clinicians’ individual expertise and patients own preference/expectations are enjoined to achieve the best possible outcome. Since its inception in 1990s, evidence-based medicine has evolved in conjunction with numerous changes in the healthcare environment. However, the benefits of evidence-based medicine have not materialized for spinal pain including surgical interventions. Consequently, the debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Friedly et al published a randomized controlled trial of epidural glucocorticoid injections for spinal stenosis in the July 2014 edition of the highly prestigious New England Journal of Medicine,. This was accompanied by an editorial from Andersson. This manuscript provided significant sensationalism for the media and confusion for the spine community. This randomized trial of epidural glucocorticoid injections for spinal stenosis and accompanying editorial concluded that epidural injections of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injections of lidocaine alone, with the editorial emphasizing proceeding directly to surgical intervention. In addition media statements by the authors also emphasized the idea that exercise or surgery might be better options for patients suffereing from narrowing of the spinal canal. The interventional pain management community believes that there are severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation. The design of the trial was inappropriate with failure to include existing randomized trials, with inclusion criteria that did not incorporate conservative management,or caudal epidural injections. Simultaneously, acute pain patients were included, multilevel stenosis and various other factors were not identified. The interventions included lumbar interlaminar and transforaminal epidural injections with highly variable volumes of medication being injected per patient. Outcomes assessment was not optimal with assessment of the patients at 3 and 6 weeks for a procedure which provides on average 3 weeks of relief and utilizing an instrument which is more appropriately utilized in acute and subacute low back pain. Analysis of the data was hampered by inadequate subgroup analysis leading to inappropriate interpretation. Based on the available data epidural local anesthetic with steroids was clearly superior at 3 weeks and potentially at 6 weeks. Further, both treatments were effective considering the baseline to 3 week and 6 week assessment, appropriate subgroup analysis seems to have yielded significant superiority for interlaminar epidural injections compared to transforaminal epidural injections with local anesthetic with or without steroids specifically with proportion of patients achieving greater than 50% improvement at 3 and 6 week levels. This critical assessment shows that this study suffers from a challenging design, was premised on the exclusion of available highquality literature, and had inadequate duration of follow-up for an interventional technique with poor assessment criteria and reporting. Finally the analysis and interpretation of data has led to inaccurate and inappropriate conclusions which we do not believe is based on scientific evidence. Key words: Chronic low back pain, central spinal stenosis, epidural injections, local anesthetics, steroids, randomized trials, outcomes assessment

Ultrasound-Guided vs. Fluoroscopy-Guided Caudal Epidural Steroid Injection for the Treatment of Unilateral Lower Lumbar Radicular Pain

Ultrasound-Guided vs. Fluoroscopy-Guided Caudal Epidural Steroid Injection for the Treatment of Unilateral Lower Lumbar Radicular Pain

Ultrasound as a screening tool for performing caudal epidural injections.

Background:The caudal approach to the epidural space has been used for decades to treat low back pain caused by lumbosacral root compression. The use of fluoroscopy during epidural steroid injection is the preferred method for placing the needle more accurately in the sacral hiatus, but it carries the risk of radiation hazard.Objectives:The aim of the study was to assess the anatomical structure of the sacral hiatus and the feasibility of caudal epidural injections under ultrasound guidance.Patients and Methods:Two hundred and forty patients (male = 100, female = 140) with low back pain and sciatica who were candidates for caudal epidural injection were enrolled into this study. Ultrasound images of the sacral hiatus and bilateral cornua were obtained by a real-time linear array ultrasound transducer. The distance between bilateral cornua and the anterior and posterior wall of the sacrum were measured at the base (sacral hiatus). Under the guide of ultrasonography, we defined the injection successful if turbulence of medication fluid was observed in the sacral canal, but correct placement of the needle and injectant was confirmed on fluoroscopic view as the gold standard technique.Results:The epidurogram showed that the injection was successful in 230 of the 240 patients (95.8%). In eight patients, the injection was not in the correct place in the sacral canal. The sacral hiatus could not be identified by ultrasound images in only two patients who had a closed sacral hiatus identified by fluoroscopy. The mean distance of the sacral hiatus was 4.7 ± 1.7 mm and the mean distance between bilateral cornua was 18.0 ± 2.8 mm. The mean duration of the procedure was 10.8 ± 6.8 minutes. No major complication was observed in the next month.Conclusions:In conclusion, ultrasound could be used as a safe, fast and reliable modality to observe the anatomic variation of the sacral hiatus and to perform caudal epidural injections.

Cost Utility Analysis of Percutaneous Adhesiolysis in Managing Pain of Post‐lumbar Surgery Syndrome and Lumbar Central Spinal Stenosis

The increase in the number of interventions for the management of chronic pain and associated escalation of healthcare costs has captured the attention of health policymakers, in no small part due to the lack of documentation of efficacy, cost-effectiveness, or cost utility analysis. A recent cost utility analysis of caudal epidural injections in managing chronic low back pain of various pathologies showed a high cost utility with improvement in quality of life years, competitive with various other modalities of treatments. However, there are no analyses derived from high-quality controlled studies related to the cost utility of percutaneous adhesiolysis in the treatment of post-lumbar surgery syndrome or lumbar central spinal stenosis. This analysis is based on 2 previously published controlled studies. To assess the cost utility of percutaneous adhesiolysis procedures in managing chronic low back and lower extremity pain secondary to post-lumbar surgery syndrome and lumbar central spinal stenosis. A private, specialty referral interventional pain management center in the United States. Two controlled studies were conducted assessing the clinical effectiveness of percutaneous adhesiolysis for post-lumbar surgery syndrome and lumbar central spinal stenosis in an interventional pain management setting utilizing contemporary interventional pain management practices. A cost utility analysis was performed with direct payment data for a total of 130 patients in treatment groups over a 2-year period. Various outcome measures were included with significant improvement, defined as at least 50% improvement with reduction in pain and disability status. The results of 2 controlled studies of low back pain with 60 and 70 patients and a 2-year follow-up with the actual reimbursement data showed cost utility for 1year of quality-adjusted life year (QALY) of USD $2,652 for post-lumbar surgery syndrome and USD $2,649 for lumbar central spinal stenosis. The results of this assessment show that the cost utility of managing chronic, intractable low back pain with percutaneous adhesiolysis at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, spinal cord stimulation, and surgery. The limitations of this cost utility analysis are that it is a single-center evaluation, with the inclusion of costs of adhesiolysis procedures in an ambulatory surgery center and physician visits, rather than all related costs including drug therapy and costs of disability in multiple settings. This cost utility analysis of percutaneous adhesiolysis in the treatment of post-lumbar surgery syndrome and lumbar central spinal stenosis shows the clinical effectiveness and cost utility of these procedures at USD $2,650 per one year of QALY when performed in an ambulatory surgery center.

Caudal vs Transforaminal Epidural Steroid Injections as Short-Term (6 Months) Pain Relief in Lumbar Spinal Stenosis Patients with Sciatica

The aim of this study is to evaluate prospectively the efficacy of caudal epidural steroid injection (CESI) and transforaminal epidural steroid injection (TFESI) in lumbar spinal stenosis patients with sciatic pain. Prospective clinical study. Thirty-one patients (average age 62 years) from two hospitals, with single dermotomal distribution of sciatic pain due to spinal stenosis were included in the study. Patients underwent epidural steroid injections done by the same injectionist. Eleven patients from one hospital were included in the CESI group, while the TFESI group consisted of 20 comparable patients from the second site. Primary outcome measure was the complete relief or at least 50% reduction of pain (visual analog scale [VAS]) at 6 months postinjection. Secondary outcome measures were the improvement of function (of at least 15 points of Oswestry Disability Index [ODI]) at 6 months and the changes of VAS and ODI and at 2 weeks, at 3 months, and at 6 months postinjection. A significantly greater number of stenosis patients showed pain relief at 6 months postinjection with TFSI (90%) than with CESI (54.54%). All patients with TFSI showed improvement of function at 6 months while only three (27.27%) patients with caudal epidural improved functionally. Out of the total 31 patients, two patients from group A underwent a second CESI at 15 days postinjection and decompressive spine surgery between 3 and 6 months postinjection. The effectiveness of transforaminal steroid injection for the stenosis patients with sciatica was superior to caudal at 6 months postinjection.

Kein Vorteil der epiduralen Injektion vs. oraler Medikation und Physiotherapie bei Ischialgie, unabhängig von der Beschwerdedauer

The study presented here investigated the short-term effectiveness of one-off lumbar caudal epidural injection (EI) in sciatica in relationship to the reported duration of pain. This retrospective analysis involved 106 consecutive in-patients who received either conservative treatment (Group I) or an additional EI on the first day of their treatment (Group II). Both groups were divided according to the duration of symptoms at the time of admission (less than three months, or more than six months). Propensity score matching was performed for the whole collective and the resulting subgroups. This incorporated gender, age and pain intensity at the time of admission. The target parameter were changes on a visual analogue scale (VAS) of pain intensity on days D1, D3, and D10 depending on the respective treatment. A routine evaluation of the mental variables anxiety, depression and somatisation was performed as part of the examination upon admission and their relationship to the success of treatment was later assessed. The mean age of the patients was 61.7 (± 11.6) in Group I and 63.6 (± 13.6) in Group II. 59 % of the patients were female (n = 63). The Lasègue sign was prevalent in 45 % of Group I and 51 % of Group II. The intensity of pain on the day of admission was similar in both groups (7.0 ± 1.0 for Group I, 6.7 ± 1.8 for Group II). The length of stay on the ward was also similar in both groups (10.2 ± 3.9 and 9.4 ± 3.7 d, respectively). It was found that, independent of the duration of symptoms, injection treatment was significantly more effective than conservative treatment only in the early stages (D1 and D3, p < 0.001). No differences could be found in the expression of these mental variables between treatment groups, as these factors showed no influence on the results of therapy. In the context of acute treatment a once only lumbar caudal epidural injection represents at most a short-term effectiveness for the therapy of sciatica. The results presented here indicate that neither the duration of symptoms nor the measured psychometric variables show any effect on the success of therapy.

Do Epidural Injections Provide Short- and Long-term Relief for Lumbar Disc Herniation? A Systematic Review.

As part of a comprehensive nonsurgical approach, epidural injections often are used in the management of lumbar disc herniation. Recent guidelines and systematic reviews have reached different conclusions about the efficacy of epidural injections in managing lumbar disc herniation. In this systematic review, we determined the efficacy (pain relief and functional improvement) of the three anatomic approaches (caudal, lumbar interlaminar, and transforaminal) for epidural injections in the treatment of disc herniation. We performed a literature search from 1966 to June 2013 in PubMed, Cochrane library, US National Guideline Clearinghouse, previous systematic reviews, and cross-references for trials studying all types of epidural injections in managing chronic or chronic and subacute lumbar disc herniation. We wanted only randomized controlled trials (RCTs) (either placebo or active controlled) to be included in our analysis, and 66 studies found in our search fulfilled these criteria. We then assessed the methodologic quality of these 66 studies using the Cochrane review criteria for RCTs. Thirty-nine studies were excluded, leaving 23 RCTs of high and moderate methodologic quality for analysis. Evidence for the efficacy of all three approaches for epidural injection under fluoroscopy was strong for short-term (<6months) and moderate for long-term (≥6months) based on the Cochrane rating system with five levels of evidence (best evidence synthesis), with strong evidence denoting consistent findings among multiple high-quality RCTs and moderate evidence denoting consistent findings among multiple low-quality RCTs or one high-quality RCT. The primary outcome measure was pain relief, defined as at least 50% improvement in pain or 3-point improvement in pain scores in at least 50% of the patients. The secondary outcome measure was functional improvement, defined as 50% reduction in disability or 30% reduction in the disability scores. Based on strong evidence for short-term efficacy from multiple high-quality trials and moderate evidence for long-term efficacy from at least one high quality trial, we found that fluoroscopic caudal, lumbar interlaminar, and transforaminal epidural injections were efficacious at managing lumbar disc herniation in terms of pain relief and functional improvement. The available evidence suggests that epidural injections performed under fluoroscopy by trained physicians offer improvement in pain and function in well-selected patients with lumbar disc herniation.

CAUDAL EPIDURAL INJECTIONS FOR LUMBAR PROLAPSED INTER VERTEBRAL DISC: ASSESSMENT WITH URDU VERSION OF OSWESTRY DISABILITY INDEX

Background/Aims: Oswestry Disability index is an established tool for assessment of Spinal Disability. It has been translated into many languages and but observational study was translation, application and validation of Urdu version of the Oswestry Disability Index (Urdu ODI) for our specific cultural background. Methods: Urdu version of ODI was developed and applied for outcome assessment in 50 patients, suffering from lumbar prolapsed inter vertebral discs and treated with caudal epidural steroid injection. All patients having mechanical low backache with radiculopathy and single level disc prolapse at L-4-5 or L5-S1 on Magnetic Resonance Imaging (MRI) were included in the study. Single Steroid Injection with local anesthetic was injected into sacral caudal epidural space through sacral hiatus. A Performa was made for each patient and records were kept in a custom built Microsoft access database. Outcome was assessed using Urdu ODI and validation by comparing with Numeric rating Scale 0-10 at each visit. Results: Fifty patients received caudal epidural injections, 23 (46%) were male and 27 (54%) were female. The mean age was 34 years, with the range being 21-55. Low mechanical backache with right sided radiculopathy was in 29 (58%) and left sided in 21 (42%) patients. The commonest involved disc was L4-5 in 28 (56%) and L5-S1 in 22 (44%) patients Pain was assessed with Numeric Rating Scale (NRS) of ten points. This was mean 7.35, range 9-6 at presentation and mean improvement was 4.15 with range 5-3 at fist week, 3.80 with range 5-2 at first month and 3.05 with range 4-1 after six months. Functional disability assessment was done using Urdu ODI. The mean Urdu ODI at the time of presentation was 66.23% with range 81%-48%. The mean functional status was found to be 38.64% with range 26%-45% at the end of the first week, 43.65% with range 31%-48% after one month and 44.85% with range 28%-48% after six months. So there was mean improvement in score of Urdu ODI: 41.65% at the end of the first week, 34.09% after the first month and 32.28% after the end of six months. Pain at injection site was the only complication in 4 (8%) patients. Conclusion: Urdu ODI is useful tool for assessment of spinal disability in Pakistani population. This will meet the local cultural and literacy requirement. Caudal epidural injection can be injected in Out Patient Clinics safely with good outcome avoiding surgery in majority of the cases. To our knowledge this is the first Urdu translation and validation of ODI. Key Words: Oswestry Disability Index, ODI, Urdu Oswestry Disability Index, Urdu ODI, Caudal Epidural Injection

RE: The risks of epidural and transforaminal steroid injections in the spine: Commentary and a comprehensive review of the literature.

Dear Editor, We read with interest the comprehensive literature review and commentary by Dr. Epstein of the risks of epidural and transforaminal steroid injections in the spine.[5] While this manuscript appears to be comprehensive, we are concerned with the lack of evidence in the opinions offered. We disagree with Dr. Epstein's understanding of the literature and makes unusual claims discrediting all interventional techniques even though the title says “epidural and transforaminal steroid injections in the spine.” Further, the author appears to not recognize that transforaminal injections and caudal epidural injections are in facet epidural injections.[8,9] Dr. Epstein has selected all the negative studies and provided seemingly erroneous interpretations of other literature leading to what we believe are best termed inappropriate conclusions. It would appear that her focus may have been on the contaminated epidural steroid injections resulting in meningitis. However, she postulated a multitude of other issues based on incidence of infection from contaminated steroids, projecting that epidural injections are typically short-acting and ineffective over the long-term, exposing patients to major risks and complications, with delay in surgery. Even the very unusually high and unimaginable complications she is describing in these manuscripts of adhesive arachnoiditis of 6-16%, intravascular injections, etc., along with other life-threatening complications are not based on the literature she has reviewed. Even with the extraordinary statements re: Complications in interventional pain procedures, they may well be less when compared with the risks of intraspinous fusion devices in which Dr. Epstein described maximal complication rates of 38%, reoperation rates of 85%, poor outcomes in 77%, along with high costs of the device.[7] Additionally, per Dr. Epstein many operations that are recommended are not necessary or are too complex.[6] The author, in the description of complications and outcomes of interlaminar and transforaminal epidural injections, seems to use the manuscript of facet joint nerve blocks by Manchikanti et al.[20] alleging 11.4% intravascular injury and 76.3% bleeding. This would be a gross misinterpretation of that study. There was no intravascular injury described in this manuscript by Manchikanti et al.,[20] which rather described intravascular entry, unrelated to epidural injections. An assessment of outcomes should describe at least all randomized trials. Instead Dr. Epstein appears to have picked only a few studies with negative results. Based on inadequate utilization of literature, she describes that patients are subject to major life-threatening risks, while delaying potential requisite surgery. Per above, prior reports by Dr. Epstein of surgical complications are enormous.[7] Overall this manuscript would be appropriate for describing the infectious complications based on contaminated steroid injection. Multiple manuscripts in literature[8,10,11,12,13,14,15,16,18,19,21,22,23,24,25,26] have shown equal effectiveness of epidural injections on a long-term basis, along with facet joint nerve blocks, even though that was not the subject of this review, and have shown significant improvement with outcomes of at least 50% pain relief with functional status improvement of 50% over a period of 2 years. A recent systematic review also confirmed these findings.[3] Multiple complications related to transforaminal epidural injections are justifiable;[8,9] however, these complications are related to mainly cervical epidural injections and based on the radicular entry and injection of particulate steroids. The author seems to make multiple statements not substantiated by literature. This trend extended to the clinical effectiveness, complications, and also costs and provides misinterpretations. She quotes Manchikanti et al.[20] as providing a multitude of data, which was not related to this manuscript or to other manuscripts.[17] The author has also made multiple statements regarding financial incentives not described in any of the manuscripts. The author also describes two major types of epidural spinal injections, translaminar and transforaminal; however, there is also a caudal epidural injection. In assessment of the efficacy of epidural injections, one would review all the literature; however, this review is lacking focus on selective literature and using the literature related to the complications in the efficacy. She also described one study by Manchikanti;[14] which was a positive study, and made no comments. Parr et al.[27] is cited in reference to short-term pain relief for disc herniation and radiculitis and evidence was lacking for both short- and long-term treatment from an earlier systematic review published in 2009 rather than using the manuscript published by Benyamin et al.[1] In fact, recent guidelines[8] and multiple systematic reviews[1,2,4,9,28] have provided similar evidence for interlaminar epidural injections, caudal epidural injections, and lumbar transforaminal epidural injections performed in interventional pain management settings under fluoroscopy with proper selection of patients. However, there is no evidence for transforaminal cervical epidural injections. Overall, this manuscript is confusing. It is our opinion that it provides multiple elements of misinformation rather than evidence-based opinions.

Use of magnetic resonance imaging to identify outcome predictors of caudal epidural steroid injections for lower lumbar radicular pain caused by a herniated disc.

ObjectiveWe used lumbar magnetic resonance image (MRI) findings to determine possible outcome predictors of a caudal epidural steroid injection (CESI) for radicular pain caused by a herniated lumbar disc (HLD).MethodsNinety-one patients with radicular pain whose MRI indicated a HLD were enrolled between September 2010 and July 2013. The CESIs were performed using ultrasound (US). A responder was defined as having complete relief or at least a 50% reduction of pain as assessed by the visual analog scale (VAS) and functional status on the Roland Morris Disability Questionnaire (RMDQ); responder (VAS n=61, RMDQ n=51), and non-responder (VAS n=30, RMDQ n=40). MRI findings were analyzed and compared between the two groups with regard to HLD level, HLD type (protrusion or exclusion), HLD zone (central, subarticular, foraminal, and extraforaminal), HLD volume (mild, moderate, or severe), relationship between HLD and nerve root (no contact, contact, displaced, or compressed), disc height loss (none, less than half, or more than half ), and disc degeneration grade (homogeneous disc structure or inhomogeneous disc structure-clear nucleus and height of intervertebral disc).ResultsA centrally located herniated disc was more common in the responder group than that in the non-responder group. Treatment of centrally located herniated discs showed satisfactory results. (VAS p=0.025, RMDQ p=0.040). Other factors, such as HLD level, HLD type, HLD volume, relationship to nerve root, disc height loss, and disc degeneration grade, were not critical.ConclusionThe HLD zone was significant for pain reduction after CESI. A centrally located herniated disc was a predictor of a good clinical outcome.

Assessment of factors affecting the difficulty of caudal epidural injections in adults using ultrasound.

In unaided caudal epidural block (CEB), incorrect needle insertion has been reported to occur in 15% to 38% of attempts. To statistically analyze the anatomical variables affecting difficult CEB using ultrasonographic measurement. Preprocedural ultrasonography was performed and the following measurements were obtained in 146 patients: the distance from the skin to the apex of the sacral hiatus; the depth of the sacral canal at the apex of the sacral hiatus; the length of the sacrococcygeal ligament between the apex of the sacral hiatus and sacral base; the distance from the skin to the apex of the sacral cornu; and the distance between the apexes of bilateral cornua. One clinician, unaware of the ultrasonographic findings, performed the injections using the landmark technique. The procedures were videotaped and were subsequently reviewed by an independent investigator. The means (± SDs) of the abovementioned measurements were 12.1±3.7 mm, 6.1±2.1 mm, 25.9±7.4 mm, 10.0±4.0 mm and 16.4±3.2&nbsp;mm, respectively. Injections failed in 16 (11%) patients and were defined as difficult in 21 (14.4%) patients. The depth of the sacral canal at the apex of sacral hiatus (P<0.001) and the length of the sacrococcygeal ligament between the apex of the sacral hiatus and sacral base (P=0.001) were significant predictors of difficult CEB. Of all patients, 85.7% and 75.2% were correctly classified as difficult or not difficult, respectively. The cutoff values of the depth of the sacral canal at the apex of the sacral hiatus and the length of the sacrococcygeal ligament between the apex of the sacral hiatus and the sacral base to predict a difficult CEB were 3.7 mm and 17.6 mm, respectively. Both the depth of the sacral canal at the apex of the sacral hiatus and the length of the sacrococcygeal ligament between the apex of the sacral hiatus and sacral base are significant variables affecting the difficulty of the CEB.

Caudal epidural steroid injection in the treatment of chronic discogenic low back pain. Comparative, prospective and randomized study

ObjectiveThere is no consensus on the treatment of chronic low back pain of disk origin in the medical literature. The few prospective, randomized, controlled studies evaluating the effectiveness of caudal epidural steroid injections (CESI) have obtained contradictory results. The aim of this study is to evaluate the efficacy of CEI in reducing pain and improving the associated disability. Material and methodThis is a prospective, randomized, case-control study of a group of 46 patients with chronic low back disk pain. Patients were randomly allocated into 2 groups to either receive fluoroscopy guided CESI (CESI-group), or oral non-steroidal anti-inflammatory drugs (NSAID-group). All patients were clinically evaluated at 4, 12, and 24 weeks, and according to the indications of the Spanish Society for Study of Diseases of the Spine (GEER). ResultsLumbar pain, measured by the visual analog scale (VAS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ), did not improve significantly during follow-up in any of the two study groups (p>0.05). Younger patients, women, patients with shorter duration of symptoms, low physical job demand, without leg pain, and sport-active, included in CESI-group showed a trend toward better results, but none reached statistical significance (p>0.05). ConclusionsThe present study has not demonstrated the superiority of CESI over NSAIDs in treating chronic low back pain of disk origin. While CESI could show some improvement in patients with degenerative lumbar disk disease, we consider it should be used with caution, informing patients about realistic expectations on the success of treatment.

Assessment of the Growth of Epidural Injections in the Medicare Population from 2000 to 2011

Background: Among the many diagnostic and therapeutic interventions available for the management of chronic pain, epidural steroid injections are one of the most commonly used modalities. The explosive growth of this technique is relevant in light of the high cost of health care in the United States and abroad, the previous literature assessing the effectiveness of epidural injections has been sparse with highly variable outcomes based on technique, outcome measures, patient selection, and methodology. However, the recent assessment of fluoroscopically directed epidural injections has shown improved evidence with proper inclusion criteria, methodology, and outcome measures. The exponential growth of epidural injections is illustrated in multiple reports. The present report is an update of the analysis of the growth of epidural injections in the Medicare population from 2000 to 2011 in the United States. Study Design: Analysis of utilization patterns of epidural procedures in the Medicare population in the United States from 2000 to 2011. Objectives: The primary purpose of this assessment was to evaluate the use of all types of epidural injections (i.e., caudal, interlaminar, and transforaminal in the lumbar, cervical, and thoracic regions) with an assessment of specialty and regional characteristics. Methods: This assessment was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician/Supplier Procedure Summary (PSPS) Master data from 2000 to 2011. Results: Epidural injections in Medicare beneficiaries increased significantly from 2000 to 2011. Overall, epidural injections increased 130% per 100,000 Medicare beneficiaries with an annual increase of 7.5%. The increases per 100,000 Medicare recipients were 123% for cervical/ thoracic interlaminar epidural injections; 25% for lumbar/sacral interlaminar, or caudal epidural injections; 142% for cervical/thoracic transforaminal epidural injections; and 665% for lumbar/ sacral transforaminal epidural injections. The use of epidurals increased 224% in the radiologic specialties (interventional radiology and diagnostic radiology) and 145% in psychiatric settings, whereas and physical medicine and rehabilitation physicians’ use of epidurals increased 520%. Limitations: Study limitations include lack of inclusion of Medicare Advantage patients. In addition, the statewide data is based on claims which may include the contiguous or other states. Conclusions: Epidural injections in Medicare recipients increased significantly. The growth was significant for some specialties (radiology, physical medicine and rehabilitation, and psychiatry) and for certain procedures (lumbosacral transforaminal epidural injections). Key words: Spinal pain, interventional pain management, epidural injections, caudal epidural, lumbar epidural, cervical epidural, cervical transforaminal, lumbar transforaminal

Infiltración esteroidea epidural por vía caudal en el tratamiento del dolor lumbar crónico de origen discal. Estudio comparativo, prospectivo y aleatorizado

ObjectiveThere is no consensus on the treatment of chronic low back pain of disc origin in the medical literature. The few prospective, randomized, controlled studies evaluating the effectiveness of caudal epidural steroid injections (CESI) have obtained contradictory results. The aim of this study is to evaluate the efficacy of CEI in reducing pain and improving the associated disability. Material and methodThis is a prospective, randomized, case-control study of a group of 46 patients with chronic low back disc pain. Patients were randomly allocated into 2 groups to either receive fluoroscopy guided CESI (CESI-group), or oral non-steroidal anti-inflammatory drugs (NSAID-group). All patients were clinically evaluated at 4, 12, and 24 weeks, and according to the indications of the Spanish Society for Study of Diseases of the Spine (GEER). ResultsLumbar pain, measured by the visual analog scale (VAS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ), did not improve significantly during follow-up in any of the two study groups (P>.05). Younger patients, women, patients with shorter duration of symptoms, low physical job demand, without leg pain, and sport-active, included in CESI-group showed a trend towards better results, but none reached statistical significance (P>.05). ConclusionsThe present study has not demonstrated the superiority of CESI over NSAIDs in treating chronic low back pain of disc origin. While CESI could show some improvement in patients with degenerative lumbar disc disease, we consider it should be used with caution, informing patients about realistic expectations on the success of treatment.

Motor Weakness after Caudal Epidural Injection Using the Air-acceptance Test

Air injected into the epidural space may spread along the nerves of the paravertebral space. Depending on the location of the air, neurologic complications such as multiradicular syndrome, lumbar root compression, and even paraplegia may occur. However, cases of motor weakness caused by air bubbles after caudal epidural injection are rare. A 44-year-old female patient received a caudal epidural injection after an air-acceptance test. Four hours later, she complained of motor weakness in the right lower extremity and numbness of the S1 dermatome. Magnetic resonance imaging showed no anomalies other than an air bubble measuring 13 mm in length and 0.337 ml in volume positioned near the right S1 root. Her symptoms completely regressed within 48 hours.

Ultrasound-Guided vs. Fluoroscopy-Guided Caudal Epidural Steroid Injection for the Treatment of Unilateral Lower Lumbar Radicular Pain

The aim of this study was to compare the short-term effects and advantages of ultrasound-guided caudal epidural steroid injections with fluoroscopy-guided epidural steroid injections for unilateral radicular pain in the lower lumbar spine. A total of 120 patients with unilateral radicular pain were enrolled and randomly assigned to either the fluoroscopy or the ultrasound group. Complication frequencies during the procedures, treatment effects, functional improvement, and adverse events were compared after the procedures. The verbal numerical rating scale and the Oswestry Disability Index improved 2 and 12 wks after the injections in both groups. Statistical differences were not observed in the verbal numerical rating scale, the Oswestry Disability Index, or the effectiveness of the procedure between the groups. Two cases of intravascular injections were observed in the fluoroscopy group, without the prevalence of complication between the groups. The ultrasound approach with color Doppler mode may avoid intravascular injection-induced complications. The results showed similar improvements in short-term pain relief, function, and patient satisfaction with both ultrasound and fluoroscopic guidance.

Cost Utility Analysis of Caudal Epidural Injections in the Treatment of Lumbar Disc Herniation, Axial or Discogenic Low Back Pain, Central Spinal Stenosis, and Post Lumbar Surgery Syndrome

Background: In this era of escalating health care costs and the questionable effectiveness of multiple interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine, and has an influence coverage decisions. Even though multiple cost effectiveness analysis studies have been performed over the years, extensive literature is lacking for interventional techniques. Cost utility analysis studies of epidural injections for managing chronic low back pain demonstrated highly variable results including a lack of cost utility in randomized trials and contrasting results in observational studies. There has not been any cost utility analysis studies of epidural injections in large randomized trials performed in interventional pain management settings. Objectives: To assess the cost utility of caudal epidural injections in managing chronic low back pain secondary to lumbar disc herniation, axial or discogenic low back pain, lumbar central spinal stenosis, and lumbar post surgery syndrome. Study Design: This analysis is based on 4 previously published randomized trials. Setting: A private, specialty referral interventional pain management center in the United States. Methods: Four randomized trials were conducted assessing the clinical effectiveness of caudal epidural injections with or without steroids for lumbar disc herniation, lumbar discogenic or axial low back pain, lumbar central spinal stenosis, and post surgery syndrome. A cost utility analysis was performed with direct payment data for a total of 480 patients over a period of 2 years from these 4 trials. Outcome included various measures with significant improvement defined as at least a 50% improvement in pain reduction and disability status. Results: The results of 4 randomized controlled trials of low back pain with 480 patients with a 2 year follow-up with the actual reimbursement data showed cost utility for one year of quality-adjusted life year (QALY) of $2,206 for disc herniation, $2,136 for axial or discogenic pain without disc herniation, $2,155 for central spinal stenosis, and $2,191 for post surgery syndrome. All patients showed significant improvement clinically and showed positive results in the cost utility analysis with an average cost per one year QALY of $2,172.50 for all patients and $1,966.03 for patients judged to be successful. The results of this assessment show a better cost utility or lower cost of managing chronic, intractable low back pain with caudal epidural injections at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, and surgery in most cases. Limitations: The limitations of this cost utility analysis include that it is a single center evaluation, even though 480 patients were included in the analysis. Further, only the costs of interventional procedures and physician visits were included. The benefits of returning to work were not assessed. Conclusion: This cost utility analysis of caudal epidural injections in the treatment of disc herniation, axial or discogenic low back pain, central spinal stenosis, and post surgery syndrome in the lumbar spine shows the clinical effectiveness and cost utility of these injections at less than $2,200 per one year of QALY. Key words: Caudal epidural injections, chronic low back pain, lumbar disc herniation, lumbar discogenic pain, lumbar spinal stenosis, lumbar post surgery syndrome, cost utility analysis, cost effectiveness analysis, quality-adjusted life years

An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part II: Guidance and Recommendations

Objective: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. Methodology: Systematic assessment of the literature. Evidence: I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. Anticoagulation • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There islimited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events. Conclusion: Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed. Disclaimer: The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent “standard of care.” Key words: Interventional techniques , chronic spinal pain, diagnostic blocks, therapeutic interventions, facet joint interventions, epidural injections, epidural adhesiolysis, discography, radiofrequency, disc decompression, spinal cord stimulation, intrathecal implantable systems

Color Flow Doppler Ultrasonography Can Distinguish Caudal Epidural Injection from Intrathecal Injection

Color flow Doppler ultrasonography has been used to confirm caudal epidural injection, but its ability to detect accidental intrathecal injection is unknown. We hypothesized that, when using color flow Doppler, the injection of fluid into the epidural space would result in turbulent flow which would appear as a burst of color while intrathecal injection would show an absence of a color flow Doppler signal. Two groups of pediatric patients (up to 6 years of age) were prospectively enrolled for this observational study during a 2-month period. One group (group E) consisted of patients suitable for elective surgery using caudal epidural analgesia, and the other (group I) included patients receiving lumbar puncture for intrathecal chemotherapeutic injection. After induction of general anesthesia and placement of the patient in the lateral position, an 8 MHz curved array probe (Sonosite TITAN, Bothell, WA) was applied to obtain a transverse image of the lumbar region (L1-L3). Real-time images using color flow Doppler were obtained and recorded during initial injections of 2 consecutive (20 seconds apart) aliquots of 0.1 mL/kg medication of local anesthetic (0.25% bupivacaine) or chemotherapy drugs (mixture of methotrexate, cytarabine, and hydrocortisone) at a rate of 0.5 to 1.0 mL/s. After obtaining the study images, the rest of the medication was injected in standard fashion. A blinded anesthesiologist later evaluated the recorded images to determine a positive or negative result (positive = presence of turbulence as illustrated by a medley of color; negative = no turbulence or color). Sensitivity, specificity, and positive and negative predictive values were calculated for those patients who had successful analgesia (group E) and intrathecal (group I) injections. Forty recorded images from 41 patients (group E, n = 21; group I, n = 20) were included in the analysis. The observed sensitivity, specificity, positive predictive value, and negative predictive values were all 100%. The lower 95% confidence limits were 0.832. In the context of this study, color flow Doppler could differentiate epidural from intrathecal injection into the caudal space of children up to 6 years of age using a 0.1 mL/kg injection volume and injection rate of 0.5 to 1.0 mL/s.

Cauda Equina Syndrome Caused by Epidural Pneumorrhachis

A case report and review of the literature. To present a rare case, and its treatment, of cauda equina syndrome (CES) caused by epidural pneumorrhachis after repeated caudal epidural injections. Pneumorrhachis is defined as the presence of air in the epidural or subarachnoid space. Epidural pneumorrhachis is usually asymptomatic and managed conservatively, but rare cases of lumbar radiculopathy resulting from epidural air have been reported. To the best of our knowledge, there has been no previous report of CES caused by epidural air. A 63-year-old male presented with recent aggravation of a low backache, with pain radiating to both lower limbs. He also complained of newly developed numbness in the buttocks, groins, and perineum, and difficulty with urination and defecation, after repeated caudal epidural injections during a 3-week period. Computed tomography and magnetic resonance imaging revealed epidural pneumorrhachis compressing the lumbar dural sac at the L2-L3 and L3-L4 levels. The patient's symptoms persisted despite 3 days of oxygen inhalation therapy. Attempted needle aspiration of the epidural air was unsuccessful and percutaneous computed tomography-guided translaminar trephination was performed. The day after trephination, the patient's lower extremity motor strength began to improve; sphincter dysfunction began to resolve on the second day. During 8 weeks, his pain resolved and he gradually regained sensation. Two years later, the patient was free of symptoms or signs of CES. Epidural pneumorrhachis may cause dural sac compression, thus worsening a patient's previous symptoms and possibly eliciting new problems such as CES. Conservative treatment should be the first-line approach, but surgery is often necessary when the problem remains unsolved. Percutaneous computed tomography-guided translaminar trephination may be an alternative to surgical decompression of the epidural space in selected patients.