A Randomized, Double-Blind Controlled Trial
of Lumbar Interlaminar Epidural Injections in
Central Spinal Stenosis: 2-Year Follow-Up

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

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A Randomized, Double-Blind, Active-Controlled Trial of Fluoroscopic Lumbar Interlaminar Epidural Injections in Chronic Axial or Discogenic Low Back Pain: Results of 2-Year Follow-Up

January 2018 - Pain Physician ◽

10.36076/ppj.2013/16/e494 ◽

2013 ◽

Vol 5;16 (5;9) ◽

pp. E494-E504

Author(s):

Laxmaiah Manchikanti

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Disc Herniation ◽

Local Anesthetic ◽

Controlled Trial ◽

Low Back ◽

Discogenic Pain ◽

Double Blind ◽

Epidural Injections ◽

Discogenic Low Back Pain

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

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

January 2018 - Pain Physician ◽

10.36076/ppj.2014/17/e327 ◽

2014 ◽

Vol 3;17 (3;5) ◽

pp. E327-E338 ◽

Cited By ~ 3

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

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

January 2018 - Pain Physician ◽

10.36076/ppj.2014/17/e489 ◽

2014 ◽

Vol 4;17 (4;7) ◽

pp. E489-E501

Author(s):

Laxmaiah Manchikanti

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Disc Herniation ◽

Local Anesthetic ◽

Chloride Solution ◽

Sodium Chloride Solution ◽

Lumbar Disc ◽

Low Back ◽

Double Blind ◽

Epidural Injections

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

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Caudal Epidural Injections in the Management of Chronic Low Back Pain: A Systematic Appraisal of the Literature

January 2018 - Pain Physician ◽

10.36076/ppj.2012/15/e159 ◽

2012 ◽

Vol 3;15 (3;5) ◽

pp. E158-E198

Author(s):

Allan T. Parr

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Spinal Stenosis ◽

Disc Herniation ◽

Local Anesthetic ◽

Chronic Low Back Pain ◽

Low Back ◽

Discogenic Pain ◽

Epidural Injections ◽

Caudal Epidural

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

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