scholarly journals A Randomized, Double-Blind, Active Control Trial of Fluoroscopic Cervical Interlaminar Epidural Injections in Chronic Pain of Cervical Disc Herniation: Results of a 2-Year Follow-Up

2013 ◽  
Vol 5;16 (5;9) ◽  
pp. 465-478
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Disc Herniation ◽  
Local Anesthetic ◽  
Cervical Disc Herniation ◽  
Treatment Modalities ◽  
Cervical Disc ◽  
Double Blind ◽  
Epidural Injections ◽  
Group I ◽  
Successful Group ◽  
Group Ii

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

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
Keyword(s):  
Neck Pain ◽  
Upper Extremity ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Chronic Neck Pain ◽  
Cervical Disc Herniation ◽  
Cervical Disc ◽  
Epidural Injections ◽  
Group I ◽  
Group Ii

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

scholarly journals Cervical Epidural Injections in Chronic Discogenic Neck Pain Without Disc Herniation or Radiculitis: Preliminary Results of a Randomized, Double-Blind, Controlled Trial

2010 ◽  
Vol 4;13 (4;7) ◽  
pp. E265-E278
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Neck Pain ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Facet Joint ◽  
Chronic Neck Pain ◽  
Double Blind ◽  
Epidural Injections ◽  
Group I ◽  
Group Ii ◽  
Facet Joint Pain

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

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

2012 ◽  
Vol 1;15 (1;1) ◽  
pp. E59-E70
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Relief ◽  
Spinal Stenosis ◽  
Local Anesthetic ◽  
Chronic Neck Pain ◽  
Double Blind ◽  
Epidural Injections ◽  
Significant Pain ◽  
Group I ◽  
Cervical Spinal Stenosis ◽  
Group Ii

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

scholarly journals Fluoroscopic Cervical Interlaminar Epidural Injections in Managing Chronic Pain of Cervical Postsurgery Syndrome: Preliminary Results of a Randomized, Double-Blind, Active Control Trial

2012 ◽  
Vol 1;15 (1;1) ◽  
pp. 13-26
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Pain Relief ◽  
Neck Pain ◽  
Upper Extremity ◽  
Local Anesthetic ◽  
Chronic Neck Pain ◽  
Double Blind ◽  
Epidural Injections ◽  
Group I ◽  
Group Ii ◽  
Neck Disability

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.

scholarly journals A Randomized, Double-Blind, Active-Control Trial of the Effectiveness of Lumbar Interlaminar Epidural Injections in Disc Herniation

2014 ◽  
Vol 17;1 (1;17) ◽  
pp. E61-E74 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Functional Status ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Controlled Trial ◽  
Low Back ◽  
Double Blind ◽  
Epidural Injections ◽  
Group I ◽  
Interventional Pain Management

Background: Among the multiple nonsurgical modalities, epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis. There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up. Study Design: Randomized, double-blind, active-controlled trial with 2-year follow-up. Setting: An interventional pain management practice in the United States. Objective: The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis. Methods: Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone. Outcome Measures: The primary outcome measure was defined as pain relief and functional status improvement of 50%. The outcomes were assessed by numeric rating scale (NRS) of pain and functional status with Oswestry Disability Index (ODI). Secondary outcome measures included employment status and opioid intake. Results: Results showed significant improvement in 60% of patients in Group I and 70% of patients in Group II at the end of 2 years. In addition, in the successful groups, those with at least 3 weeks of relief (with the first 2 procedures), the improvement was 72% in Group I and 71% in Group II. Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group. Thus, the results indicate that a patient’s failure to respond to local anesthetic alone, may be treated with addition of steroids. 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 is an effective modality, in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities. Key words: Lumbar disc herniation, lumbar radiculitis, lumbar interlaminar epidural injections, local anesthetic, steroids, randomized controlled trial, active-controlled trial

scholarly journals Effect of Fluoroscopically Guided Caudal Epidural Steroid or Local Anesthetic Injections in the Treatment of Lumbar Disc Herniation and Radiculitis: A Randomized, Controlled, Double Blind Trial with a Two-Year Follow-Up

2012 ◽  
Vol 4;15 (4;8) ◽  
pp. 273-286 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Lower Extremity ◽  
Outcome Measures ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Low Back ◽  
Epidural Injections ◽  
Lower Extremity Pain ◽  
Group I ◽  
Group Ii ◽  
Caudal Epidural

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

scholarly journals Thoracic Interlaminar Epidural Injections in Managing Chronic Thoracic Pain: A Randomized, Double-Blind, Controlled Trial with a 2-Year Follow-Up

2014 ◽  
Vol 3;17 (3;5) ◽  
pp. E327-E338 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Back Pain ◽  
Local Anesthetic ◽  
Controlled Trial ◽  
Low Back ◽  
Thoracic Pain ◽  
Double Blind ◽  
Thoracic Epidural ◽  
Epidural Injections ◽  
Group I ◽  
Group Ii

Background: Reports of prevalence of spinal pain indicate the prevalence of thoracic pain in approximately 13% of the general population compared to 32% of the population with neck pain and 43% of the population with low back pain during the past year. Even though, thoracic pain is less common than neck or low back pain, the degree of disability resulting from thoracic pain disorders seems to be similar to other painful conditions. Interventions in managing chronic thoracic pain are also less frequent, leading to the paucity of literature about various interventions in managing chronic thoracic pain. Thoracic intervertebral discs and thoracic facet joints have been shown to be pain generators, even though thoracic radicular pain is very infrequent. Thoracic epidural injections are one of the commonly performed procedures in managing thoracic pain. The efficacy of thoracic epidural injections has not been well studied. Study Design: A randomized, double-blind, active controlled trial. Setting: Private interventional pain management practice and specialty referral center in the United States. Objective: The primary objective was to assess the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief and improving function in patients with chronic mid and/ or upper back pain. Methods: One hundred and ten patients were randomly assigned into 2 groups with 55 patients in each group receiving either local anesthetic alone (Group I) or local anesthetic with steroids (Group II). Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Outcomes were assessed utilizing Numeric Rating Scale (NRS), the Oswestry Disability Index (ODI) 2.0, employment status, and opioid intake. The patients experiencing greater than 3 weeks of significant improvement with the first 2 procedures were considered as successful. Others were considered as failed participants. Significant improvement was defined as a decrease of greater than 50% NRS scores and ODI scores with measurements performed at baseline, 3, 6, 12, 18, and 24 months post treatment. Results: Significant improvement was seen in 71% in Group I and 80% in Group II at the end of 2 years with all participants; however, improvement was seen in 80% and 86% when only successful patients were considered. Therapeutic procedural characteristics showed 5 to 6 procedures per 2 years with total average relief of 80 weeks in Group I and 78 weeks in Group II in the successful patient category; whereas, it was 71 and 72 weeks when all patients were considered. Limitations: Limitations of this assessment include lack of a placebo group.Conclusions: Based on the results of this trial, it is concluded that chronic thoracic pain of non-facet joint origin may be managed conservatively with thoracic interlaminar epidural injections with or without steroids. Key words: Chronic thoracic pain, chest wall pain, disc herniation, discogenic pain, radiculitis, thoracic interlaminar 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 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 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

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