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

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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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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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

January 2018 - Pain Physician ◽

10.36076/ppj.2008/11/785 ◽

2008 ◽

Vol 6;11 (12;6) ◽

pp. 785-800 ◽

Cited By ~ 1

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

January 2018 - Pain Physician ◽

10.36076/ppj/2015.18.79 ◽

2015 ◽

Vol 18;1 (1;1) ◽

pp. 79-92

Author(s):

Laxmaiah Manchikanti

Keyword(s):

United States ◽

Low Back Pain ◽

Back Pain ◽

Spinal Stenosis ◽

Local Anesthetic ◽

Controlled Trial ◽

The United States ◽

Low Back ◽

Double Blind ◽

Epidural Injections

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-Control Trial of the Effectiveness of Lumbar Interlaminar Epidural Injections in Disc Herniation

January 2018 - Pain Physician ◽

10.36076/ppj.2014/17/e61 ◽

2014 ◽

Vol 17;1 (1;17) ◽

pp. E61-E74 ◽

Cited By ~ 7

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

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

January 2018 - Pain Physician ◽

10.36076/ppj.2009/12/109 ◽

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

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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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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

January 2018 - Pain Physician ◽

10.36076/ppj.2011/14/25 ◽

2011 ◽

Vol 1;14 (1;1) ◽

pp. 25-36 ◽

Cited By ~ 1

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

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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

January 2018 - Pain Physician ◽

10.36076/ppj.2010/13/e279 ◽

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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Platelet-Rich Plasma Releasate versus Corticosteroid for the Treatment of Discogenic Low Back Pain: A Double-Blind Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm11020304 ◽

2022 ◽

Vol 11 (2) ◽

pp. 304

Author(s):

Koji Akeda ◽

Kohshi Ohishi ◽

Norihiko Takegami ◽

Takao Sudo ◽

Junichi Yamada ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Controlled Clinical Trial ◽

Walking Ability ◽

Low Back ◽

Disability Score ◽

Double Blind ◽

Discogenic Low Back Pain

Clinical application of platelet-rich plasma is gaining popularity in treating low back pain (LBP). This study investigated the efficacy and safety of platelet-rich plasma releasate (PRPr) injection into degenerated discs of patients with discogenic LBP. A randomized, double-blind, active-controlled clinical trial was conducted. Sixteen patients with discogenic LBP received an intradiscal injection of either autologous PRPr or corticosteroid (CS). Patients in both groups who wished to have PRPr treatment received an optional injection of PRPr eight weeks later. The primary outcome was change in VAS from baseline at eight weeks. Secondary outcomes were pain, disability, quality of life (QOL), image analyses of disc degeneration, and safety for up to 60 weeks. The VAS change at eight weeks did not significantly differ between the two groups. Fifteen patients received the optional injection. Compared to the CS group, the PRPr group had a significantly improved disability score at 26 weeks and walking ability scores at four and eight weeks. Radiographic disc height and MRI grading score were unchanged from baseline. PRPr caused no clinically important adverse events. PRPr injection showed clinically significant improvements in LBP intensity equal to that of CS. PRPr treatment relieved pain, and improved disability and QOL during 60 weeks of observation.

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