scholarly journals Transforaminal Epidural Injections in Chronic Lumbar Disc Herniation: A Randomized, Double-Blind, Active-Control Trial

2014 ◽  
Vol 4;17 (4;7) ◽  
pp. E489-E501
Author(s):  
Laxmaiah Manchikanti

Background: The estimated prevalence of lumbar radiculopathy has been described as 9.8 per 1,000 cases of low back pain. There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain, including epidural injections. Epidural injection administration routes include transforaminal, interlaminar, and caudal approaches. The transforaminal approach requires the smallest volume to reach the primary site of pathology. Systematic reviews have yielded highly variable results, but a recent systematic review showed no significant difference among the 3 approaches. Study Design: A randomized, controlled, double blind, active control trial. Setting: An interventional pain management practice, a private specialty referral center in the United States. Objectives: To assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. Methods: One hundred twenty patients were randomly assigned to 2 groups: Group I received 1.5 mL of 1% preservative-free lidocaine, followed by 0.5 mL of sodium chloride solution. Group II received 1% lidocaine, followed by 3 mg, or 0.5 mL of betamethasone. The sodium chloride solution and betamethasone were either clear liquids or were provided in opaquecovered syringes. Outcomes Assessment: The primary outcome measure was significant improvement (at least 50%) measured by the average Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Results: At 2 years there was significant improvement in all participants in 65% who received local anesthetic alone and 57% who received local anesthetic and steroid. When separated into non-responsive and responsive categories based on initial relief of at least 3 weeks with 2 procedures, significant improvement (at least 50% improvement in pain and function) was seen in 80% in the local anesthetic group and 73% in the local anesthetic with steroid group. Limitations: Presumed limitations of this evaluation include the lack of a placebo group. Conclusion: Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up. Key words: Chronic low back pain, transforaminal epidural injections, disc herniation, radiculitis, lower extremity pain, local anesthetic, steroids

2013 ◽  
Vol 5;16 (5;9) ◽  
pp. E494-E504
Author(s):  
Laxmaiah Manchikanti

Background: Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. Although it is responsible for a very small proportion of patients, disc herniation is the primary focus of modalities of treatments. In fact, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain without disc herniation including surgery, intradiscal therapies, and epidural injections. There is, however, continued debate on the effectiveness, indications, and medical necessity of all modalities of treatments in managing axial or discogenic pain in the lumbar spine. Objectives: To assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids. Study Design: A randomized, double-blind, active-controlled trial. Setting: A private practice, specialty referral, interventional pain management practice in the United States. Methods: In this study, a total of 120 patients were randomly allocated to one of 2 groups of 60 patients receiving either local anesthetic alone or local anesthetic with steroids. The primary outcome measure was at least a 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment. Results: Significant pain relief and functional status improvement, defined as a reduction in scores from baseline of at least 50% or more, were observed in 72% of patients receiving local anesthetic alone and 67% of patients receiving local anesthetic with steroids. Opioid intake was reduced from the baseline in each group for 2 years. Limitations: The results of the study are limited by the lack of a placebo group. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis. Key words: Lumbar disc herniation, axial or discogenic pain, lumbar interlaminar epidural injections, local anesthetic, steroids, controlled comparative local anesthetic blocks


2011 ◽  
Vol 1;14 (1;1) ◽  
pp. 25-36 ◽  
Author(s):  
Laxmaiah Manchikanti

Background: Lumbar radicular pain pathophysiology continues to be the subject of research and debate as discogenic pain is increasingly seen as a cause of non-specific low back pain. Among non-surgical methods used to manage chronic low back pain with or without disc herniation, epidural injections are one of the most common modalities. However, there is little evidence utilizing contemporary methodology for using epidural injections in patients with discogenic pain. Study Design: A randomized, double-blind, active-controlled trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objectives: To evaluate the effectiveness of caudal epidural injections with local anesthetic, with or without steroids, in managing chronic low back pain without disc herniation or radiculitis. Methods: A total of 120 patients were assigned to one of 2 groups. Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5% 10 mL); Group II patients received caudal epidural injections with 9 mL of 0.5% lidocaine mixed with 1 mL of steroid (either brand name or non-particulate betamethasone [6 mg] or methylprednisolone [40 mg]. Computer-generated randomization and random allocation sequence by simple randomization were the randomization techniques utilized. Outcomes Assessment: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, functional status, and opioid intake at 3, 6, and 12 months post treatment. Significant pain relief and functional status improvement were described as a 50% or more reduction in scores from baseline. Results: Significant pain relief and functional status improvement were observed in 55% of the patients in Group I and 68% of the patients in Group II. In contrast, 84% of patients in Group I and 85% in Group II saw significant pain relief and functional status improvement in the successful group (62% in Group I and 68% in Group II). The average procedures per year were 3.8 ± 0.9 for Group I and 4.3 ± 0.9 for Group II. Average pain scores decreased from 8.0 ± 0.9 to 4.3 ± 1.79 for Group I and from 7.9 ± 1.0 to 3.8 ± 1.59 for Group II. There were no differences among the patients receiving one of the 3 steroids. Limitations: The results of this study are limited by lack of a placebo group. Conclusion: Caudal epidural injections with local anesthetic with or without steroids are effective in patients with chronic low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis. Clinical Trial: NCT00370799 Key words: Chronic low back pain, lower extremity pain, discogenic pain, facet joint pain, disc herniation, radiculitis, lumbar interlaminar epidural injections, epidural steroids, local anesthetic


2010 ◽  
Vol 4;13 (4;7) ◽  
pp. E279-E292
Author(s):  
Laxmaiah Manchikanti

Background: Low back pain without disc herniation is the most common problem among chronic pain disorders. Epidural injections are commonly used interventions in managing chronic low back pain without disc herniation. However, little evidence exists regarding the effectiveness, indications, and medical necessity of lumbar epidural injections in managing axial low back pain without disc herniation or radiculitis. Study Design: A randomized, double-blind, controlled trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objectives: To evaluate the ability to provide effective and long-lasting pain relief with lumbar interlaminar epidural injections with local anesthetic with or without steroids in managing chronic low back pain not caused by disc herniation or radiculitis. Methods: Patients were randomly assigned to one of 2 groups with Group I patients receiving local anesthetic only, whereas Group II patients received local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Outcome measures included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. The assessments were done at baseline, 3 months, 6 months, and 12 months post-treatment. Significant pain relief and/or improvement in disability were defined as at least 50% improvement. Results: Significant pain relief (≥ 50%) was demonstrated in 74% of patients in Group I and 63% in Group II. Functional status improvement (reduction of ≥ 50%) in the ODI scores was seen in 71% of patients in Group I and 60% of patients in Group II. The overall average procedures per year were approximately 4. Limitations: The results of this study are limited by the lack of a placebo group and that it is a preliminary report of 35 patients in each group with a total of 70 patients. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids was effective in 63% and 74% of patients with chronic function-limiting low back pain without facet joint pain, disc herniation, and/or radiculitis. Key words: Chronic low back pain, lumbar interlaminar epidural injections, discogenic pain, disc herniation, radiculitis, local anesthetic, steroids, controlled comparative local anesthetic blocks


2017 ◽  
Vol 4 (20;4) ◽  
pp. 219-228 ◽  
Author(s):  
Laxmaiah Manchikanti

Background: Cost utility or cost effective analysis continues to take center stage in the United States for defining and measuring the value of treatments in interventional pain management. Appropriate cost utility analysis has been performed for caudal epidural injections, percutaneous adhesiolysis, and spinal cord stimulation. However, the literature pertaining to lumbar interlaminar epidural injections is lacking, specifically in reference to cost utility analysis derived from randomized controlled trials (RCTs) with a pragmatic approach in a practical setting. Objectives: To assess the cost utility of lumbar interlaminar epidural injections in managing chronic low back and/or lower extremity pain secondary to lumbar disc herniation, spinal stenosis, and axial or discogenic low back pain. Study Design: Analysis based on 3 previously published randomized trials of effectiveness of lumbar interlaminar epidural injections assessing their role in disc herniation, spinal stenosis, and axial or discogenic pain. Setting: A contemporary, private, specialty referral interventional pain management center in the United States. Methods: Cost utility of lumbar interlaminar epidural injections with or without steroids in managing lumbar disc herniation, central spinal stenosis, and discogenic or axial low back pain was conducted with data derived from 3 RCTs that included a 2-year follow-up, with inclusion of 360 patients. The primary outcome was significant improvement defined as at least a 50% in pain reduction and disability status. Direct payment data from 2016 was utilized for assessment of procedural costs. Overall costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.67 to accommodate for indirect payments respectively for disc herniation, spinal stenosis, discogenic pain. Results: The results of 3 RCTs showed direct cost utility for one year of quality-adjusted life year (QALY) of $2,050.87 for disc herniation, $2,112.25 for axial or discogenic pain without disc herniation, and $1,773.28 for spinal stenosis, with an average cost per one year QALY of $1,976.58, with total estimated costs of $3,425, $3,527, $2,961, and $3,301 respectively. Limitations: The limitation of this cost utility analysis includes that it is a single center evaluation, even though 360 patients were included in this analysis. Further, only the costs of interventional procedures and physician visits were assessed based on the data, with extrapolation of indirect costs presenting the overall total costs. The benefits of returning to work were not assessed. Conclusion: This cost utility analysis of lumbar interlaminar epidural injections in patients nonresponsive to conservative management in the treatment of disc herniation, central spinal stenosis, and axial or discogenic low back pain in the lumbar spine shows the clinical effectiveness and cost utility of these injections of $1,976.58 for direct costs with a total cost of $3,301 per QALY.Key words: Lumbar interlaminar epidural injections, chronic low back pain, lumbar disc herniation, lumbar discogenic pain, cost utility analysis, cost effectiveness analysis, qualityadjusted life years


2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 785-800 ◽  
Author(s):  
Laxmaiah Manchikanti

Background: Intervertebral discs, facet joints, ligaments, fascia, muscles, and nerve root dura have been described as tissues capable of transmitting pain in the low back. The pathophysiology of spinal radicular pain is the subject of ongoing research and controversy with discogenic pain assuming a major role as a cause of non-specific low back pain. Even though epidural injections are frequently administered in managing axial low back pain, the evidence is lacking. Study Design: A randomized, double-blind, equivalence trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objectives: To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back pain without disc herniation or radiculitis in providing effective and longlasting pain relief and to evaluate the differences between local anesthetic with or without steroids. Methods: Patients were randomly assigned to one of 2 groups, Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid. Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as reduction of 40% or more. Results: Significant pain relief (≥ 50%) was demonstrated in 72% to 81% of patients and functional status improvement was demonstrated by a reduction of 40% in the ODI scores in 81% of the patients. The overall average procedures per year were 3.6 ± 1.05 in Group I and 3.9 ± 1.33 in Group II with an average total relief per year of 32.3 ± 16.93 weeks in Group I and 30.7 ± 17.94 weeks in Group II over a period of 52 weeks. Limitations: The results of this study are limited by lack of a placebo group and a preliminary report of 36 patients in each group. Conclusion: Caudal epidural injections with or without steroids may be effective in patients with chronic function-limiting low back pain without facet joint pain, disc herniation, and/or radiculitis in over 70% of the patients. Key words: Chronic low back pain, caudal epidural injections, discogenic pain, disc herniation, radiculitis, local anesthetic, steroids, controlled comparative local anesthetic blocks, provocation discography


2012 ◽  
Vol 3;15 (3;5) ◽  
pp. E158-E198
Author(s):  
Allan T. Parr

Background: Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on their effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular. Study Design: A systematic review of caudal epidural injections with or without steroids in managing chronic pain secondary to lumbar disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and discogenic pain without disc herniation or radiculitis. Objective: To evaluate the effect of caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain emanating as a result of disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and chronic discogenic pain. Methods: The available literature on caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for fluoroscopic observational studies. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized. Results: For this systematic review, 73 studies were identified. Of these, 51 were excluded and a total of 16 studies met inclusion criteria for methodological quality assessment with 11 randomized trials and 5 nonrandomized studies. For lumbar disc herniation, the evidence is good for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. In managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome, the indicated evidence is fair. Limitations: The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation. Conclusion: There was good evidence for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. Further, this systematic review also provided indicated evidence of fair for caudal epidural injections in managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome. Key words: Chronic low back pain, lower extremity pain, lumbar disc herniation, lumbar radiculitis, lumbar discogenic pain, post lumbar laminectomy or surgery syndrome, spinal stenosis, caudal epidural injections, steroids, local anesthetic


2015 ◽  
Vol 18;1 (1;1) ◽  
pp. 79-92
Author(s):  
Laxmaiah Manchikanti

Background: While low back pain is the number one cause of disability in the United States, lumbar spinal stenosis along with intervertebral disc herniation and degenerative spondylolisthesis is one of the 3 most common diagnosis of low back and leg pain for which surgery is performed. Numerous modalities of treatments including drug therapy and complex surgical fusions have been recommended for treatment of central spinal stenosis. Epidural injections are one of the commonly performed nonsurgical interventions in managing central spinal stenosis; however, there has been paucity of literature in reference to efficacy of epidural injections in managing central spinal stenosis with lumbar interlaminar epidural injections. Study Design: A randomized, double-blind, active controlled trial. Setting: Private interventional pain management practice and specialty referral center in the United States. Objective: To assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. Methods: A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of betamethasone. Outcomes Assessment: Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. Results: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. Limitations: Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis. Key words: Chronic low back pain, lower extremity pain, central spinal stenosis, interlaminar epidural injections, caudal epidural injections, steroids, local anesthetics, placebo, active control


2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Britta K. Krautwurst ◽  
Jürgen R. Paletta ◽  
Sylvia Mendoza ◽  
Adrian Skwara ◽  
Melvin Mohokum

Objective. Detection of a lateral shift (LS) in patients with diagnosed disc herniation compared to healthy controls. Summary of Background Data. A specific lateral shift (LS) pattern is observed in patients with disc herniation and low back pain, as shown in earlier studies. Methods. Rasterstereography (RS) was used to investigate the LS. Thirty-nine patients with lumbar disc herniation diagnosed by radiological assessment and low back pain and/or leg pain (mean age 48.2 years, mean BMI 28.5, 28 males and 11 females) and 36 healthy controls (mean age 47.4 years, mean BMI 25.7, 25 males and 11 females) were analysed. LS, pelvic tilt, pelvic inclination, lordotic angle, and trunk torsion were assessed. Results. The patient group showed a nonsignificant increase in LS, that is, 5.6 mm compared to the healthy controls with 5.0 mm (p = 0.693). However, significant differences were found between groups regarding pelvic tilt in degrees (patients 5.9°, healthy controls 2.0°; p = 0.016), trunk torsion (patients 7.5°, controls 4.5°; p = 0.017), and lordotic angle (patients 27.5°, healthy controls 32.7°; p = 0.022). The correlation between pain intensity and the FFbH-R amounted 0.804 (p = < 0.01), and that between pain intensity and the pain disability index was 0.785 (p < 0.01). Discussion. Although some studies have illustrated LS with disc herniation and low back pain, the present findings demonstrate no significant increase in LS in the patient group compared to healthy controls. Conclusion. The patients with lumbar disc herniation did not demonstrate an increased LS compared to healthy controls. Other parameters like pelvic tilt and inclination seemed to be more suitable to identify changes in posture measured by RS in patients with low back pain or disc herniation.


2010 ◽  
Vol 20 (3) ◽  
pp. 491-499 ◽  
Author(s):  
Yun Peng Huang ◽  
Sjoerd M. Bruijn ◽  
Jian Hua Lin ◽  
Onno G. Meijer ◽  
Wen Hua Wu ◽  
...  

2020 ◽  
Vol 136 (1) ◽  
pp. 88-106
Author(s):  
Filippo Migliorini ◽  
Nicola Maffulli ◽  
Jörg Eschweiler ◽  
Marcel Bestch ◽  
Markus Tingart ◽  
...  

Abstract Introduction Lumbar disc herniation (LDH) is a common cause of low back pain (LBP). Recently, in the setting of LBP caused by LDH, a growing interest in ozone therapies has been observed. Source of data Recent published literatures. Areas of agreement Being low back pain more common in the elderlies, exploring conservative alternatives to the surgical intervention is of especial interest. Areas of controversy Efficacy and feasibility of ozone injections for LDH is debated. Several clinical studies showed controversial results, and the true benefit has not yet been clarified. Growing points Systematically summarize current evidences, analyze the quantitative available data and investigate the role of percutaneous ozone therapy for LDH. Areas timely for developing research Current evidence encourage the use of ozone therapy for LBP from LDH. These conclusions should be interpret in light of the limitations of the present study.


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