scholarly journals Results of 2-Year Follow-Up of a Randomized, Double-Blind, Controlled Trial of Fluoroscopic Caudal Epidural Injections In Central Spinal Stenosis

2012 ◽  
Vol 5;15 (5;9) ◽  
pp. 371-384
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Spinal Stenosis ◽  
Low Back ◽  
Epidural Injections ◽  
Group I ◽  
Successful Group ◽  
Group Ii ◽  
Caudal Epidural

Background: Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, there is a paucity of literature concerning the treatment of spinal stenosis symptoms. Multiple interventions, including surgery and interventional techniques such as epidural injections and adhesiolysis, are commonly utilized in managing pain related to central spinal stenosis. However, there is a paucity of literature from randomized, controlled trials about the effectiveness of epidural injections for lumbar central spinal stenosis. Objective: This study sought to assess the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief for the management of chronic low back pain related to lumbar central stenosis. Study Design: A randomized, double-blind, active-controlled trial. Methods: One hundred patients were randomly assigned to one of 2 groups, with Group I patients receiving caudal epidural injections of 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, 6 mg (non-particulate betamethasone). Outcomes Assessment: Multiple outcome measures, including the Numeric Pain Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake were utilized. Assessments were carried out at 3, 6, 12, 18, and 24 months posttreatment. The primary outcome was defined as pain relief and improvement in disability scores of 50% or more. Successful treatment was considered as at least 3 weeks of relief following the first 2 injections, categorizing these patients into a successful group, and others into a failed group. Results: Significant pain relief and functional status improvement were seen in 51% in Group I and 57% in Group II at the end of 2 years in the successful group when the participants were separated into successful and failed groups. However, overall, significant pain relief and functional status improvement (≥ 50%) was demonstrated in 38% in Group I and 44% in Group II at the end of 2 years. The overall number of procedures for 2 years were 4 in both groups, with 5 procedures on average in the successful groups, and approximately 60 weeks of relief in Group I and 54 weeks of relief in Group II at 2 years in the successful group. Conclusion: Caudal epidural injections of local anesthetic with or without steroids provide relief in a modest proportion of patients undergoing the treatment and may be considered as an effective treatment for a select group of patients who have chronic function-limiting low back and lower extremity pain secondary to central spinal stenosis. Key Words: Low back pain, lower extremity pain, spinal stenosis, epidural injections, steroids, local anesthetics

scholarly journals Preliminary Results of a Randomized, Equivalence Trial of Fluoroscopic Caudal Epidural Injections in Managing Chronic Low Back Pain: Part 4 — Spinal Stenosis

2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 833-848
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Lower Extremity ◽  
Spinal Stenosis ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Epidural Injections ◽  
Group I ◽  
Caudal Epidural

Background: Spinal stenosis is one of the 3 most common diagnoses of low back and leg symptoms which also include disc herniation and degenerative spondylolisthesis. Spinal stenosis is a narrowing of the spinal canal with encroachment on the neural structures by surrounding the bone and soft tissue. In the United States, one of the most commonly performed interventions for managing chronic low back pain are epidural injections, including their use for spinal stenosis. However, there have not been any randomized trials and evidence is limited with regards to the effectiveness of epidural injections in managing chronic function-limiting low back and lower extremity pain secondary to lumbar spinal stenosis. 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 providing effective and long-lasting pain relief in the management of chronic low back pain in spinal stenosis and to evaluate the differences between local anesthetic with or without steroids. Methods: Patients were randomly assigned to one of 2 groups, with Group I patients receiving caudal epidural injections of 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 is being 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 55% to 65% of the patients and functional status improvement with 40% reduction in ODI scores in 55% to 80% of the patients. The overall average procedures per year were 3.4 ± 1.27 in Group I and 2.6 ± 1.35 in Group II with an average total relief per year of 30.3 ± 19.49 weeks in Group I and 23.1 ± 21.36 weeks in Group II over a period of 52 weeks. Limitations: The results of this study are limited by the lack of a placebo group and a preliminary report of 20 patients in each group, even though sample was justified. Conclusion: Caudal epidural injections with or without steroids may be effective in patients with chronic function-limiting low back and lower extremity pain with spinal stenosis in approximately 60% of the patients. Key words: Low back pain, lower extremity pain, spinal stenosis, epidural injections, steroids, local anesthetics

scholarly journals Management of Pain of Post Lumbar Surgery Syndrome: One-Year Results of a Randomized, Double-Blind, Active Controlled Trial of Fluoroscopic Caudal Epidural Injections

2010 ◽  
Vol 6;13 (6;12) ◽  
pp. 519-521
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Local Anesthetic ◽  
Low Back ◽  
Lumbar Surgery ◽  
Epidural Injections ◽  
Group I ◽  
One Year ◽  
Caudal Epidural

Background: Post lumbar surgery syndrome represents a cluster of nomenclature and syndromes following spine surgery wherein the expectations of the patient and spine surgeon are not met, with persistent pain following lumbar surgery. Multiple causes have been speculated to cause pain after lumbar surgery. Epidural steroid injections are most commonly used in managing post surgical pain in the lumbar spine. However, there is a paucity of evidence of epidural injections in managing chronic low back pain with or without lower extremity pain in post surgery syndrome. 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 in patients with chronic low back and lower extremity pain after surgical intervention with post lumbar surgery syndrome. Methods: One-hundred forty 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 6 mg non-particulate Celestone. 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 and disability reduction were described as 50% or more reduction in scores from baseline. Results: Combined pain relief (≥50%) and disability reduction was recorded in 53% of the patients in the local anesthetic group, and 59% of patients in the local anesthetic and steroid group with no significant differences noted with or without steroid over a period of one-year. However, the data from the successful group showed improvement in 70% of patients in Group I and 75% of patients in Group II. The average procedures per year were 4 with an average total relief per year of 38.1 ± 14.5 weeks in Group I and 38.4 ± 13.2 weeks in Group II over a period of 52 weeks in the successful group. Limitations: The results of this study are limited by the lack of a placebo group and one-year outcomes. Conclusion: Caudal epidural injections in chronic function-limiting low back pain in post surgery syndrome without facet joint pain may be effective in a significant proportion of patients with improvement in functional status and significant pain relief. Key words: Post lumbar surgery syndrome, post lumbar laminectomy syndrome, chronic low back pain, epidural adhesions, epidural steroid injections, epidural fibrosis, recurrent disc herniation, spinal stenosis

scholarly journals Preliminary Results of a Randomized, DoubleBlind, Controlled Trial of Fluoroscopic Lumbar Interlaminar Epidural Injections in Managing Chronic Lumbar Discogenic Pain Without Disc Herniation or Radiculitis

2010 ◽  
Vol 4;13 (4;7) ◽  
pp. E279-E292
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Epidural Injections ◽  
Group I ◽  
Group Ii

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

scholarly journals One-Year Results of a Randomized, Double-Blind, Active Controlled Trial of Fluoroscopic Caudal Epidural Injections With or Without Steroids in Managing Chronic Discogenic Low Back Pain Without Disc Herniation or Radiculitis

2011 ◽  
Vol 1;14 (1;1) ◽  
pp. 25-36 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Epidural Injections ◽  
Group I ◽  
Group Ii ◽  
Caudal Epidural

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

scholarly journals Lumbar Interlaminar Epidural Injections in Central Spinal Stenosis: Preliminary Results of a Randomized, Double-Blind, Active Control Trial

2012 ◽  
Vol 1;15 (1;1) ◽  
pp. 51-63 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Relief ◽  
Lower Extremity ◽  
Spinal Stenosis ◽  
Local Anesthetic ◽  
Low Back ◽  
Epidural Injections ◽  
Lower Extremity Pain ◽  
Group I ◽  
Successful Group ◽  
Group Ii

Background: Chronic, persistent low back and lower extremity pain is often caused by spinal stenosis. Surgery and other interventions, including epidural injections, have been used to relieve this pain. However, there is little in the medical literature to support interlaminar, or transforaminal epidural injections under fluoroscopy for managing lumbar pain of central spinal stenosis, while the caudal epidural approach has been studied. Study Design: A randomized, double-blind, active control trial. Setting: A private, interventional pain management practice, specialty referral center in the United States. Objective: This study sought to determine if low back and lower extremity pain secondary to lumbar central stenosis can be managed and long-lasting pain relief can be achieved with interlaminar epidural injections of local anesthetic, with or without steroids. Methods: The study comprised 2 groups: one that received local anesthetic only and another received local anesthetic combined with nonparticulate betamethasone. A total of 120 patients were randomized by a computer-generated random allocations sequence to one of the 2 groups. The results of 30 patients in each group were assessed. Outcomes Assessment: Sixty patients were included in this analysis. Outcomes measurements were taken at baseline and at 3, 6, and 12 months post-treatment. Measurements taken were Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status and opioid intake. A decrease in both the NRS and ODI of ≥ 50% was considered significant. Results: Significant pain relief and improvement in ODI scores were seen in both groups at 12 months. Group I’s significant pain relief was 70%; Group II’s was 63%. The significant ODI improvement in Group I was 70%; in Group II it was 60%. Group I patients on average received 3.8 procedures a year; Group II patients received 4.0 procedures a year in successful group. Over 52 weeks in the successful group, total relief for Group I was 40.8 ± 11.7 weeks; for Group II it was 37.1 ± 12.6 weeks. Combined pain relief and functional status improvement were seen in 80% of patients in Group I and 72% in Group II in successful group. Limitations: The lack of a placebo group and preliminary results are limitations. Conclusion: Patients might benefit from receiving lumbar interlaminar injections with or without steroids for lumbar central spinal stenosis. Key words: Chronic low back pain, lower extremity pain, lumbar spinal stenosis, central stenosis, lumbar interlaminar epidural injections, epidural steroids, local anesthetic.

Preliminary Results of a Randomized, Equivalence Trial of Fluoroscopic Caudal Epidural Injections in Managing Chronic Low Back Pain: Part 3 – Post Surgery Syndrome

2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 817-831
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Lumbar Surgery ◽  
Epidural Injections ◽  
Post Surgery ◽  
Significant Pain ◽  
Caudal Epidural

Background: Post surgery syndrome resulting in persistent pain following lumbar spine surgery is common. Speculated causes of post lumbar surgery syndrome include stenosis, degeneration of adjacent segments, internal disc disruption, recurrent disc herniation, retained disc fragment, epidural or intraneural fibrosis, radiculopathy, and various other causes. Epidural injections are most commonly used in post surgery syndrome. There is lack of evidence for the effectiveness of epidural injections in managing chronic low back pain with or without lower extremity pain secondary to post surgery syndrome. 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 in patients with chronic low back and lower extremity pain after surgical intervention with post lumbar surgery syndrome. 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 6 mg non-particulate Celestone. 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 described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more. Results: Significant pain relief (≥ 50%) was recorded in 60% to 70% of the patients with no significant differences noted with or without steroid over a period of one-year. In addition, functional assessment measured by the ODI also showed significant improvement with at least 40% reduction in Oswestry scores in 40% to 55% of the patients. The average procedures per year were 3.4 with an average total relief per year of 31.7 ± 19.10 weeks in Group I and 26.2 ± 18.34 weeks in Group II over a period of 52 weeks. Limitations: The results of this study are limited by the lack of a placebo group and the preliminary report size of only 20 patients in each group. Conclusion: Caudal epidural injections in chronic function-limiting low back pain in post surgery syndrome without facet joint pain demonstrated effectiveness with over 55% of the patients showing improvement in functional status with significant pain relief in 60% to 70%. Key words: Post lumbar surgery syndrome, post lumbar laminectomy syndrome, chronic low back pain, epidural adhesions, epidural steroid injections, epidural fibrosis, recurrent disc herniation, spinal stenosis

scholarly journals Systematic Review of Caudal Epidural Injections in the Management of Chronic Low Back Pain

2009 ◽  
Vol 1;12 (1;1) ◽  
pp. 109-135
Author(s):  
Ann Conn
Keyword(s):  
Chronic Pain ◽  
Low Back Pain ◽  
Back Pain ◽  
Lower Extremity ◽  
Spinal Stenosis ◽  
Disc Herniation ◽  
Low Back ◽  
Discogenic Pain ◽  
Epidural Injections ◽  
Caudal Epidural

Background: Caudal epidural injection of local anesthetics with or without steroids is one of the most commonly used interventions in managing chronic low back and lower extremity pain. However, there has been a lack of well-designed randomized, controlled studies to determine the effectiveness of caudal epidural injections in various conditions — disc herniation and radiculitis, post-lumbar laminectomy syndrome, spinal stenosis, and chronic low back pain of disc origin without disc herniation or radiculitis. 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 and lower extremity pain emanating as a result of disc herniation or radiculitis, post-lumbar laminectomy syndrome, spinal stenosis, and chronic discogenic pain. Methods: A review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of 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: The evidence showed Level I for short- and long-term relief in managing chronic low back and lower extremity pain secondary to lumbar disc herniation and/or radiculitis and discogenic pain without disc herniation or radiculitis. The indicated evidence is Level II-1 or II-2 for caudal epidural injections in managing low back pain of post-lumbar laminectomy syndrome and spinal stenosis. Limitations: The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation. Conclusion: This systematic review shows Level I evidence for relief of chronic pain secondary to disc herniation or radiculitis and discogenic pain without disc herniation or radiculitis. Further, the indicated evidence is Level II-1 or II-2 for caudal epidural injections in managing chronic pain of post lumbar laminectomy syndrome and spinal stenosis. 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

scholarly journals Preliminary Results of a Randomized, Equivalence Trial of Fluoroscopic Caudal Epidural Injections in Managing Chronic Low Back Pain: Part 2 — Disc Herniation and Radiculitis

2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 801-815 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Relief ◽  
Lower Extremity ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Low Back ◽  
Epidural Injections ◽  
Significant Pain ◽  
Group I ◽  
Group Ii ◽  
Caudal Epidural

Background: The pathophysiology of lumbar radicular pain is a subject of ongoing research. The prevalence of sciatica or radiculitis ranges from 1.2% to 43%. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain secondary to disc herniation and radiculitis. There is a paucity of evidence with contemporary methodology used in performing epidural injections under fluoroscopy and based on pain relief and functional status improvement. 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. Objective: To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief and evaluate the differences between local anesthetic with or without steroids. Methods: Patients were assigned to one of 2 groups; Group I patients received caudal epidural injections with an injection of 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 allocations 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 a reduction of 40% or more. Results: The percentage of patients with significant pain relief of 50% or greater at 12 months was 79% in Group I and 81% in Group II. Reduction of Oswestry scores of at least 40% was seen in 83% of the patients in Group I and 91% in Group II. The overall average procedures per year were 3.9 ± 1.26 in Group I and 3.6 ± 1.08 in Group II with an average total relief per year of 35.2 ± 17.18 weeks in Group I and 35.9 ± 15.34 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 42 patients in each group. Conclusion: Caudal epidural injections with or without steroids may be effective in patients with disc herniation or radiculitis with between 79% to 91% of patients showing significant pain relief and improvement in functional status. Key words: Chronic low back pain, disc herniation, radiculitis, lower extremity pain, caudal epidural injections, epidural steroids, local anesthetic

scholarly journals 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

2013 ◽  
Vol 3;16 (3;5) ◽  
pp. E129-E143 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Spinal Stenosis ◽  
Disc Herniation ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Low Back ◽  
Utility Analysis ◽  
Epidural Injections ◽  
Caudal Epidural

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

scholarly journals Preliminary Results of a Randomized, Equivalence Trial of Fluoroscopic Caudal Epidural Injections in Managing Chronic Low Back Pain: Part 1 — Discogenic Pain without Disc Herniation or Radiculitis

2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 785-800 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Discogenic Pain ◽  
Epidural Injections ◽  
Group I ◽  
Caudal Epidural

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

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