scholarly journals The Effectiveness of Fluoroscopic Cervical Interlaminar Epidural Injections in Managing Chronic Cervical Disc Herniation and Radiculitis: Preliminary Results of a Randomized, DoubleBlind, Controlled Trial

2010 ◽  
Vol 3;13 (3;5) ◽  
pp. 223-236
Author(s):  
Laxmaiah Manchikanti

Background: Chronic neck pain is a common problem in the adult population with a typical 12- month prevalence of 30% to 50%. Cervical disc herniation and radiculitis is one of the common conditions described responsible for chronic neck and upper extremity pain. Cervical epidural injections for managing chronic neck pain with disc herniation are one of the commonly performed non-surgical interventions in the United States. However, the literature supporting cervical interlaminar epidural steroids in managing chronic neck pain is scant. Study Design: A randomized, double-blind, controlled trial. Setting: A private interventional pain management practice and specialty referral center in the United States. Objectives: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in providing effective and long-lasting relief in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis, 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 cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received cervical interlaminar epidural injections with 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. Outcomes Assessment: Multiple outcome measures were utilized. They included the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake. Assessments were done at baseline and 3, 6, and 12 months post-treatment. Significant pain relief was defined as 50% or more; significant improvement in disability score was defined as a reduction of 50% or more. Results: Significant pain relief (≥ 50%) was demonstrated in 77% of patients in both groups. Functional status improvement was demonstrated by a reduction (> 50%) in the NDI scores in 74% of Group I and 71% of Group II at 12 months. The overall average procedures per year were 3.7 ± 1.1 in Group I and 4.0 ± 0.91 in Group II; the average total relief per year was 39.45 ± 11.59 weeks in Group I and 41.06 ± 11.56 weeks in Group II over the 52 week study period in the patients defined as successful. The initial therapy was considered to be successful if a patient obtained consistent relief with 2 initial injections lasting at least 4 weeks. All others were considered failures. Limitations: The study results are limited by the lack of a placebo group and a preliminary report of 70 patients, 35 in each group. Conclusion: Cervical interlaminar epidural injections with local anesthetic with or without steroids might be effective in 77% of patients with chronic function-limiting neck pain and upper extremity pain secondary to cervical disc herniation and radiculitis. Key words: Chronic neck pain, cervical disc herniation, upper extremity pain, cervical epidural injections, epidural steroids, local anesthetics

2012 ◽  
Vol 1;15 (1;1) ◽  
pp. 13-26
Author(s):  
Laxmaiah Manchikanti

Background: Cervical postsurgery syndrome is common with increasing cervical surgical interventions. Cervical spine surgery may fail in a certain proportion of patients with continued pain secondary to pseudoarthrosis, adjacent segment degeneration, inadequate decompression, iatrogenic instability, facet joint arthritis, deformity, and spinal stenosis. Among the various treatments available for managing cervical postsurgery syndrome, epidural steroid injections are one of the most common nonsurgical interventions. However there have not been any systematic evaluations regarding the effectiveness of cervical epidural injections in cervical postsurgery syndrome. Study Design: A randomized, double-blind, active control trial. Setting: A specialty referral, private interventional pain management practice in the United States. Objectives: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in providing effective and long-lasting relief in the management of chronic neck pain and upper extremity pain in patients with cervical postsurgery syndrome, 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 cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received cervical interlaminar epidural injections with 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. The study was designed to include 120 patients with 60 patients in each group. This analysis includes 56 patients. Randomization was performed by computer-generated, random allocation sequence by simple randomization. Outcomes Assessment: Outcome measures included the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake. Assessments at baseline and 3, 6, and 12 months posttreatment. Significant pain relief was defined as 50% or more; significant improvement in NDI was defined as a reduction of 50% or more. Results: Significant pain relief (≥ 50%) was demonstrated in 71% of patients in Group I and 68% of patients in Group II. Functional status improvement was demonstrated by a reduction (> 50%) in the NDI scores in 71% of Group I and 64% of Group II at 12 months. The overall average procedures per year were 4.0 ± 0.7 in Group I and 4.1 ± 1.0 in Group II; the average total relief per year was 39.6 ± 11.8 weeks in Group I and 41.2 ± 15.8 weeks in Group II over the 52 week study period in the patients defined as successful. In the successful group, the combined pain relief and neck disability improvement was seen in 87% in Group I and 72% of the patients in Group II. Limitations: The study results are limited by the lack of a placebo group and a preliminary report of 56 patients, 28 in each group. Conclusion: Cervical interlaminar epidural injections with local anesthetic with or without steroids were effective in 67% of patients overall and 87% in Group I and 72% in Group II, in successful group patients with chronic function-limiting neck pain and upper extremity pain secondary to cervical postsurgery syndrome. Key words: Chronic neck pain, upper extremity pain, cervical disc herniation, cervical spinal stenosis, cervical postsurgery syndrome, cervical epidural injections, epidural steroids, local anesthetics.


2012 ◽  
Vol 4;15 (4;8) ◽  
pp. E405-E434
Author(s):  
Sudhir A. Diwan

Background: Chronic persistent neck pain with or without upper extremity pain is common in the general adult population with prevalence of 48% for women and 38% for men, with persistent complaints in 22% of women and 16% of men. Multiple modalities of treatments are exploding in managing chronic neck pain along with increasing prevalence. However, there is a paucity of evidence for all modalities of treatments in managing chronic neck pain. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant. Study Design: A systematic review of cervical interlaminar epidural injections for cervical disc herniation, cervical axial discogenic pain, cervical central stenosis, and cervical postsurgery syndrome. Objective: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. Methods: The available literature on cervical interlaminar epidural injections in managing chronic neck and upper extremity pain were 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 observational studies. The level of evidence was classified as good, fair, and limited 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 were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: For this systematic review, 34 studies were identified. Of these, 24 studies were excluded and a total of 9 randomized trials, with 2 duplicate studies, met inclusion criteria for methodological quality assessment. For cervical disc herniation, the evidence is good for cervical epidural with local anesthetic and steroids; whereas, it is fair with local anesthetic only. For axial or discogenic pain, the evidence is fair for local anesthetic, with or without steroids. For spinal stenosis, the evidence is fair for local anesthetic, with or without steroids. For postsurgery syndrome, the evidence is fair for local anesthetic, with or without steroids. Limitations: The limitations of this systematic review continue to be the paucity of literature. Conclusion: The evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids, fair with local anesthetic only; whereas, it is fair for local anesthetics with or without steroids, for axial or discogenic pain, pain of central spinal stenosis, and pain of post surgery syndrome. Key words: Cervical disc herniation, cervical axial discogenic pain, cervical central spinal stenosis, cervical post surgery syndrome, cervical radiculitis, cervical interlaminar epidural injections, local anesthetic, steroids


2013 ◽  
Vol 5;16 (5;9) ◽  
pp. 465-478
Author(s):  
Laxmaiah Manchikanti

Background: A recent evaluation of the state of U.S. health from 1990 to 2010 placed neck pain as the fourth condition leading to disability, with low back pain being the number one. Multiple treatment modalities have been described in managing neck and upper extremity pain secondary to cervical disc herniation after the failure of conservative management. The treatment modalities for chronic persistent pain of cervical disc herniation include surgery and epidural injections. The growth of interventional techniques in managing chronic spinal pain in recent years has been enormous. Evidence for the efficacy of cervical interlaminar epidural injections, however, continues to be debated, despite positive evidence derived from controlled randomized trials and systematic reviews. Study Design: A randomized, double-blind, active control trial. Setting: A private, specialty referral, interventional pain management practice in the United States. Objectives: To evaluate the effectiveness of epidural injections in managing chronic pain related to cervical disc herniation. Methods: Patients were randomly assigned to one of 2 groups of 60, with a total of 120 patients. Group I patients received cervical epidural injections with lidocaine 0.5% preservative-free, 5 mL, whereas Group II patients received 0.5% preservative-free lidocaine mixed with 1 mL or 6 mg of non-particulate betamethasone. Outcome Assessment: Multiple outcome measures included the numeric rating pain scale (NRS), the Neck Disability Index (NDI), employment status, opioid intake with assessment at 3, 6, 12, 18, and 24 months post treatment. Significant improvement was described as pain relief with a 50% improvement in functional status. Results: This evaluation showed significant improvement as 50% pain relief and improvement in functional status in 72% of the patients at 2 year follow-up in the local anesthetic group and 68% in those patients receiving local anesthetic and steroid. In the successful group of participants however, significant improvement was seen in 77% in Group I and 80% in Group II. Overall, the average number of procedures was 5 to 6 in both groups per 2 years. The average total relief for 2 years was 75.9 ± 29.9 weeks in Group I and 72.7 ± 31.1 in Group II, the successful group of participants. Taking into consideration all of the participants, the average total relief for 2 years was 69.6 ± 35 weeks in Group I and 62.1 ± 38.4 weeks in Group II. Limitations: The results of the study are limited by the lack of a placebo group. Conclusion: Cervical epidural injections with local anesthetic with or without steroids may offer significant benefit to patients suffering with chronic, persistent pain and disability related to cervical disc herniation. Key words: Chronic neck pain, cervical disc herniation, upper extremity pain, cervical epidural injections, epidural steroids, local anesthetics Trial Registration: NCT01071369


2010 ◽  
Vol 4;13 (4;7) ◽  
pp. E265-E278
Author(s):  
Laxmaiah Manchikanti

Background: Chronic neck pain is a common problem in the adult population with a typical 12- month prevalence of 30% to 50%. However, there is a lack of consensus regarding the causes and treatments of chronic neck pain. Despite limited evidence, cervical epidural injections are one of the commonly performed nonsurgical interventions in the management of chronic neck pain. Study Design: A randomized, double-blind, active control 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 cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with or without upper extremity pain in patients without disc herniation or radiculitis or facet joint pain. Methods: Patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of 2 groups: injection of local anesthetic only or 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: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction. Results: Significant pain relief (≥ 50%) was demonstrated in 80% of patients in both groups and functional status improvement (> 50%) in 69% of Group I and 80% of Group II. The overall average procedures per year were 3.9 ± 1.01 in Group I and 3.9 ± 0.8 in Group II with an average total relief per year of 40.3 ± 14.1 weeks in Group I and 42.1 ± 9.9 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 that it is a preliminary report of 70 patients, with 35 patients in each group. Conclusion: Cervical interlaminar epidural injections with local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic. Key words: Chronic neck pain, cervical disc herniation, cervical discogenic pain, cervical epidural injections, epidural steroids, local anesthetics


2019 ◽  
Vol 5 (22;5) ◽  
pp. 421-431
Author(s):  
Laxmaiah Manchikanti

Background: Neck pain is one of the major conditions attributing to overall disability in the United States. There have been multiple publications assessing clinical and cost effectiveness of multiple modalities of interventions in managing chronic neck pain. Even then, the literature has been considered sparse in relation to cervical interlaminar epidural injections in managing chronic neck pain. In contrast, cost utility studies of lumbar interlaminar injections, caudal epidural injections, cervical and lumbar facet joint nerve blocks, percutaneous adhesiolysis demonstrated costs of less than $3,500 for quality-adjusted life year (QALY). Objectives: To assess the cost utility of cervical interlaminar epidural injections in managing chronic neck and/or upper extremity pain secondary to cervical disc herniation, post-surgery syndrome in neck, and axial or discogenic neck pain. Study Design: Analysis based on 3 previously published randomized trials of the effectiveness of cervical interlaminar epidural injections assessing their role in disc herniation, cervical post-surgery syndrome, and axial or discogenic pain. Setting: A contemporary, private, specialty referral interventional pain management center in the United States. Methods: Cost utility of cervical interlaminar epidural injections with or without steroids in managing cervical disc herniation, cervical post-surgery syndrome, and cervical discogenic or axial neck back pain was conducted with data derived from 3 randomized controlled trials (RCTs) that included a 2-year follow-up, with inclusion of 356 patients. The primary outcome was significant improvement defined as at least 50% in pain reduction and disability status. Direct payment data from all carriers from 2018 was utilized for the 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, discogenic pain, and cervical post-surgery syndrome. Results: The results of the 3 RCTs showed direct cost utility for one year of QALY of $2,412.31 for axial or discogenic pain without disc herniation, $2,081.07 for disc herniation, and $2,309.20 for post surgery syndrome, with an average cost per one year QALY of $2,267.57, with total estimated overall costs with addition of indirect costs of $3,475.38, $4,028.55, $3,856.36, and $3,785.89 respectively. Limitations: The limitation of this cost utility analysis includes that it is a single center evaluation. Indirect costs were extrapolated. Conclusion: This cost utility analysis of cervical interlaminar epidural injections in patients nonresponsive to conservative management in the treatment of disc herniation, post surgery syndrome and axial or discogenic neck pain shows $2,267.57 for direct costs with a total cost of $3,785.89 per QALY. Key words: Cervical interlaminar epidural injections, chronic neck pain, cervical disc herniation, cervical discogenic pain, post surgery syndrome, cost utility analysis, cost effectiveness analysis, quality-adjusted life years


2012 ◽  
Vol 1;15 (1;1) ◽  
pp. E59-E70
Author(s):  
Laxmaiah Manchikanti

Background: Cervical spinal stenosis is a common disease that results in considerable morbidity and disability. There are multiple modalities of treatments, including surgical interventions and multiple interventional techniques including epidural injections. The literature on the effectiveness of cervical epidural steroids is sporadic. Emerging evidence for cervical interlaminar epidurals for various conditions in the cervical spine is positive; however, the effect of fluoroscopic epidural injections in cervical spinal stenosis has not been studied. Study Design: A randomized, double-blind, active control trial. Setting: A private interventional pain management practice, a specialty referral center in the United States. Objectives: To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with upper extremity pain in patients with cervical central spinal stenosis. Methods: Patients with cervical central spinal stenosis were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Sixty patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction of NRS or NDI scores. Results: Significant pain relief was seen in 73% in Group I and 70% in Group II, in Group II showing both significant pain relief and functional status improvements. Group I’s average relief per procedures was 11.3 ± 5.8 weeks; for Group II it was 8.6 ± 3.6 weeks, whereas after initial 2 procedures, average relief was 13.7 ± 8.7 weeks in Group I, and 13.6 ± 4.7 weeks in Group II. In the successful group, the average total relief in a one-year period was 42.2 ± 14.7 weeks in Group I and 34.3 ± 13.4 weeks in Group II, with 76% in Group I and 77% in Group II. Limitations: Study limitations include the lack of a placebo group and that this is a preliminary report of only 60 patients, 30 in each group. Conclusion: Patients who have chronic function-limiting pain that is secondary to cervical central stenosis might receive relief with cervical interlaminar epidurals of local anesthetic, whether with or without steroids. Key words: Chronic neck pain, cervical disc herniation, cervical stenosis, cervical central stenosis, cervical epidural injections, epidural steroids, local anesthetics


2009 ◽  
Vol 1;12 (1;1) ◽  
pp. 137-157
Author(s):  
Ramsin Benyamin

Background: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%, and 14% of the patients reporting grade II to IV neck pain with high pain intensity and disability that has a substantial impact on health care and society. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant and no systematic review dedicated to the evaluation of cervical interlaminar epidurals has been performed in the past. Study Design: A systematic review of cervical interlaminar epidural injections. Objective: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. Methods: The available literature of cervical interlaminar epidural injections in managing chronic neck and upper 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 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) for therapeutic interventions. 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 were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: The indicated evidence is Level II-1 in managing chronic neck and upper extremity pain. Limitations: The limitations of this systematic review include the paucity of literature and lack of randomized trials performed under fluoroscopy. Conclusion: The results of this systematic evaluation of cervical interlaminar epidural injection showed significant effect in relieving chronic intractable pain of cervical origin and also providing long-term relief with an indicated evidence level of Level II-1. Key words: Cervical disc herniation, cervical post surgery syndrome, cervical spinal stenosis, cervical radiculitis, cervical interlaminar epidural injections, local anesthetic steroids, chronic discogenic pain


2012 ◽  
Vol 4;15 (4;8) ◽  
pp. 273-286 ◽  
Author(s):  
Laxmaiah Manchikanti

Background: Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used. Study Design: A randomized, controlled, double blind, active control trial. Setting: A private, interventional pain management practice, specialty referral center in the United States. Objectives: To assess the effectiveness of fluoroscopically directed caudal epidural injections with 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 randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. Outcome Assessment: Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. Results: In the successful category, 77% of Group I had significant pain relief of ≥ 50% and functional status improvement of ≥ 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. Limitations: Presumed limitations of this evaluation include lack of a placebo group. Conclusion: Caudal 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 potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. Key words: Chronic low back pain, caudal epidural injections, disc herniation, radiculitis, lower extremity pain, local anesthetic, steroids


2018 ◽  
Vol 1 (21;1) ◽  
pp. E499-E456 ◽  
Author(s):  
Serbülent Gökhan Beyaz

Background: Numerous techniques have been developed for the treatment of disc herniation. Oxygen-ozone (O2 -O3 ) mixture therapy is a minimally invasive percutaneous treatment for disc herniation. Objective: The aim of the study is to investigate the 6-month efficacy and safety of O2 -O3 mixture therapy in patients with cervical disc herniation (CDH) and chronic neck pain. Study Design: This is a cross-sectional, single-center study. Setting: The study was conducted from January 2012 to May 2016 on patients visiting Sakarya University Training and Research Hospital’s pain clinic. Methods: Each patient was evaluated before the procedure (baseline) and at 2 weeks (W2), 6 weeks (W6), and 6 months (M6) after the procedure using the visual analog scale (VAS) and the Oswestry Disability Index scores. Results: A total of 44 patients with CDH underwent the same treatment with an O2 -O3 mixture. Significant pain relief was observed compared with preoperative pain at W2, W6, and M6 according to patient self-evaluation (P = 0.01). The mean VAS score was 7.89 ± 1.13 before the procedure, 4.22 ± 1.62 at W2, 3.03 ± 1.66 at W6, and 2.27 ± 1.25 at the end of M6. No significant complications or side effects were reported during or after the procedure. Limitations: Our study was conducted retrospectively, which resulted in problems obtaining follow-up data. In addition, this study was performed in a small patient group. Conclusion: Based on our results, intradiscal injection of an O2 -O3 mixture treatment showed a beneficial long-term effect. Key words: Cervical disc herniation, chemonucleolysis, injection, intradiscal, oxygen-ozone mixture, percutaneous treatment


2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 801-815 ◽  
Author(s):  
Laxmaiah Manchikanti

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


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