BACKGROUND: There is continued debate on the effectiveness, indications, and medical necessity of epidural injections in managing pain and disability from lumbar disc herniation, despite extensive utilization. There is paucity of literature on interlaminar epidural injections in managing lumbar disc herniation or radiculitis in contemporary interventional pain management settings utilizing fluoroscopy.
METHODS: A randomized, double-blind, active-control trial was undertaken to assess the effectiveness of lumbar interlaminar epidural injections with or without steroids for disc herniation and radiculitis. The primary outcome was defined as pain relief and functional status improvement of ≥ 50%. One hundred twenty patients were randomly assigned to 1 of the 2 groups. Group I patients received lumbar interlaminar injections containing a local anesthetic (lidocaine 0.5%, 6 mL), whereas Group II patients received lumbar interlaminar epidural injections of 0.5% lidocaine, 5 mL, mixed with 1 mL of non-particulate betamethasone.
RESULTS: In the patients who responded with initial 2 procedures with at least 3 weeks of relief, significant improvement was seen in 80% of the patients in the local anesthetic group and 86% of the patients in the local anesthetic and steroid group. The overall average procedures per year were 3.6 in the local anesthetic group and 4.1 in the local anesthetic and steroid group, with an average relief of 33.7 ± 18.1 weeks in the local anesthetic group and 39.1 ± 12.2 weeks in the local anesthetic and steroid group over a period of 52 weeks in the overall population.
CONCLUSIONS: Lumbar interlaminar epidural injections of local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis, with potential superiority of steroids compared with local anesthetic alone at 1 year follow-up.
BACKGROUND: Chronic, persistent low back and lower extremity pain is often caused by spinal stenosis. Surgery and other interventions, including epidural injections, have been used to relieve this pain. However, there is little in the medical literature to support interlaminar, or transforaminal epidural injections under fluoroscopy for managing lumbar pain of central spinal stenosis, while the caudal epidural approach has been studied.
STUDY DESIGN: A randomized, double-blind, active, control trial.
SETTING: A private, interventional pain management practice, specialty referral center in the United States.
OBJECTIVE: This study sought to determine if low back and lower extremity pain secondary to lumbar central stenosis can be managed and long-lasting pain relief can be achieved with interlaminar epidural injections of local anesthetic, with or without steroids.
METHODS: The study comprised 2 groups: one that received local anesthetic only and another received local anesthetic combined with nonparticulate betamethasone. A total of 120 patients were randomized by a computer-generated random allocations sequence to one of the 2 groups. The results of 30 patients in each group were assessed.
OUTCOMES ASSESSMENT: Sixty patients were included in this analysis. Outcomes measurements were taken at baseline and at 3, 6, and 12 months post-treatment. Measurements taken were Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status and opioid intake. A decrease in both the NRS and ODI of >/= 50% was considered significant.
RESULTS: Significant pain relief and improvement in ODI scores were seen in both groups at 12 months. Group I's significant pain relief was 70%; Group II's was 63%. The significant ODI improvement in Group I was 70%; in Group II it was 60%. Group I patients on average received 3.8 procedures a year; Group II patients received 4.0 procedures a year in successful group. Over 52 weeks in the successful group, total relief for Group I was 40.8 ± 11.7 weeks; for Group II it was 37.1 ± 12.6 weeks. Combined pain relief and functional status improvement were seen in 80% of patients in Group I and 72% in Group II in successful group.
LIMITATIONS: The lack of a placebo group and preliminary results are limitations.
CONCLUSION: Patients might benefit from receiving lumbar interlaminar injections with or without steroids for lumbar central spinal stenosis.
CLINICAL TRIAL: NCT00681447.
UNLABELLED: OBJECTIVE, DESIGN AND SETTINGS: The purpose of this randomized, prospective study is to compare the efficacy of two different routes in administering epidural steroid injections interlaminar (IL) vs transforaminal (TF) in patients with unilateral radicular pain.
PATIENTS: We randomly enrolled and followed 64 patients with chronic radiculopathy.
RESULTS: Significant improvements were maintained throughout 6 months (24 weeks) of follow-up (P<0.001, respectively). The average visual analog scale (VAS) pain scores at 24 weeks improved to 4.0 ± 2.2 cm in the IL group and 3.8 ± 2.1 cm in the TF group (P=0.717). Baseline functional capacity was comparable for the IL and the TF group (52% vs 53%) when assessed using Oswestry (P=0.647). At 6 months, both groups improved, 39% for the IL group and 38% for the TF group, suggesting change from severe to moderate disability scoring range. There were 24 out of the 32 (75%) patients in the IL group at 24 weeks who improved more than 2 cm on the VAS scale and 17 patients (53%) had >50% of the pain relief. In the TF group, there were 27 out of the 32 (84%) patients with >2 cm improvement on VAS pain scale, and 20 of 32 (63%) with >50% improvement at 24 weeks. Functional capacity changes were similar, 16 out of the 32 patients (50%) improved 10 points or more on the Oswestry scale in the IL group and 21 out of the 32 in the TF group (66%).
CONCLUSIONS: Using either route of epidural injections to deliver steroids for unilateral chronic radiculopathy secondary to herniated intervertebral disc provided significant improvements in patients function and pain relief. However, we could not find a statistically significant difference between two indicated groups either in functional improvement or in reduction in pain, although half-dose of steroids delivered via TF route provided somewhat better long-term pain relief and functional capacity improvements.
INTRODUCTION: The literature is limited in the comparative efficacy and safety of dexamethasone phosphate (DP) compared with methylprednisolone acetate (MPA) in the treatment of lumbar radiculopathy by epidural injection. This study attempts to test the hypothesis that 2 corticosteroids are equivalent in efficacy and side effects.
METHODS: Patients with lumbar radicular symptoms for at least 6 months were randomized to equipotent doses of MPA 80 mg or DP 15 mg by lumbar translaminar epidurals administered under fluoroscopy. The epidurals were administered by different nonblinded practitioners other than the authors. Preprocedure Visual Analog Scale (VAS) pain scores by preoperative pain clinic nursing staff not involved in the study. On follow-up for the second epidural at 1 to 2 months, VAS scores and any reports of adverse side effects were obtained by pain clinic nursing staff who were blinded to the type of corticosteroid used. Electronic records were also reviewed for intervening changes in medication, additional therapeutic modalities, emergency room visits, and any other complications missed on nursing follow-up.
RESULTS: There were no significant demographic differences between the DP group (N = 30) and MPA group (N = 30). The mean days to follow-up was less for the DP group (41.1) versus the MPA group (51.1), although the difference was not statistically significant (P = 0.4284). Comparing the DP group and MPA group, there was a smaller mean decrease in VAS for the DP group (-19.7%) versus the MPA group (-27.2%), although the difference was not statistically significant (P = 0.3672). Eighty-seven percent of patients in the MPA group and 90% in the DP group had decreases in postprocedure VAS with no statistically significant difference between the 2 groups (P = 0.999). Thirteen percent of the MPA group and 10% of the DP group had increases in postprocedure VAS with no significant difference between the 2 groups (P = 0.999). The percentage increase in postprocedure VAS for those who had increase in pain was 34.3% and 31.7% for the MPA and DP group, respectively with no statistically significant difference noted (P = 0.8657). Review of electronic medical records showed no change in pain medication prescribed, emergency room visits for pain, or any new treatments for pain in either group. No complications were reported by patients on nursing follow-up or seen in review of medical records including new neurological symptoms or new areas of pain.
CONCLUSIONS: Nonparticulate DP seems to be close to the safety and effectiveness of particulate MPA in the treatment of lumbar radiculopathy. There is, however, a statistically nonsignificant trend toward less pain relief and shorter duration of action that may be clarified in a larger and longer duration study.
BACKGROUND: Treating sciatica with epidural steroid injection has been a common practice worldwide. N-methyl-D-aspartate (NMDA) receptors are an important component of pain pathways.
OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of epidurally administered NMDA receptor antagonists (ketamine) for the treatment of chronic low back pain secondary to radiculopathy and its effect on patients' quality of life.
STUDY DESIGN: Randomized, double blind controlled trial.
SETTING: Hospital outpatient setting.
METHODS: Two hundred participants aged 25 to 50 years old with a diagnosis of lumbar radiculopathic pain secondary to disc herniation were randomized into 2 equal groups. Group I received 80 mg of triamcinolone (2 mL) and 0.25% bupivacaine (3 mL) plus 30 mg (3 mL) of preservative free ketamine. Group II received 80 mg of triamcinolone (2 mL) and 0.25% bupivacaine (3 mL) plus 3 mL of 0.9% saline. Pain scores were obtained before injection, immediately after injection, one week, one month, 3 months, 6 months , 9 months and one year post injection. The Oswestry Low Back Pain Disability Questionnaire was used at baseline and at one month, 3, 6, 9, and 12 months after injection for assessment of quality of life. Patients were asked to report any side effects, particularly those related to ketamine, including nausea, vomiting, visual or auditory hallucinations, and delirium.
RESULTS: Immediately after injection there was no statistically significant difference between Group I and II regarding pain scale scores. After one week of injection, pain relief was significantly better in Group I compared to Group II and then at all evaluation times. The Oswestry Low Back Pain Disability Questionnaire score decreased significantly (P < 0.05) from 72 (range 62- 83) and 70 (range 57- 82) to 8 (range 2 - 12) and 17 (range 9 - 27) at one month; 6 (range 4 - 12) and 18 (range 14 - 22) at 3 months; 12 (range 9 - 16) and 28 (range 22 - 34) at 6 months; 17 (range 9 - 24) and 31 (range 21 - 35) at 9 months; and 17 (range 8 - 22) and 33 (range 20 - 37) at 12 months in the groups, respectively. Six patients in the ketamine group showed short-lasting delusions lasting for 45 ± 12 minutes after injection.
LIMITATIONS: The limitations include a lack of placebo control.
CONCLUSION: Epidurally administrated ketamine seems to be a safe and useful adjunct to epidural corticosteroid therapy in chronic lumbar radicular pain.
BACKGROUND: The pathophysiology of lumbar radicular pain is the subject of ongoing research, with a reported prevalence of sciatica or radiculitis ranging from 1.2% to 43%. Among the numerous non-surgical interventions available, epidural injections are the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain.
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.
OBJECTIVE: To evaluate the effectiveness of lumbar interlaminar epidural injections with local anesthetic, 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.
METHODS: Patients were assigned to one of 2 groups with local anesthetic only or with local anesthetic mixed with non-particulate betamethasone. Randomization was performed by computer-generated random allocations sequence by simple randomization. Seventy patients were included in this analysis.
OUTCOMES ASSESSMENT: Patient outcomes were measured at baseline, 3, 6, and 12 months post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. Decrease of > or = 50% of NRS scores and Oswestry scores were considered significant.
RESULTS: Significant pain relief (> or = 50%) was seen at 12 months in 74% of patients in Group I and 86% in Group II, and 69% and 83% in ODI scores respectively. Significant differences were noted in pain relief characteristics at 6 months between Group I and Group II (p = 0.001) and functional status improvement was significantly better in Group II at 6 months and 12 months (p = 0.019 and 0.045). The overall average procedures per year were 4.3 in Group I and 4.2 in Group II with an average total relief per year of 42.2 +/- 10.5 weeks in Group I and 41.4 +/- 11.0 weeks in Group II over a period of 52 weeks in the successful group.
LIMITATIONS: The study limitations include the lack of a placebo group and the fact that this is a preliminary report of 35 patients in each group.
CONCLUSION: Overall, 74% of patients in Group I without steroids and 86% in Group II with steroids with lumbar disc herniation or radiculitis might benefit from lumbar interlaminar epidural injections.
BACKGROUND AND PURPOSE: An ESI for managing LBP is one of the most commonly performed interventions. The purpose of this observational study was to assess the effect of a therapeutic trial of a fluoroscopic interlaminar ESI for axial LBP and to analyze the outcome predictors. MATERIALS AND METHODS: All patients who received an interlaminar ESI for axial LBP at our facility in 2007 and 2008 were included. Initial short-term follow-up was done at <1 month after ESI. ESI was considered effective if patients had a reduction of >50% in their pain scores. In July 2009, telephone interviews were conducted by using formatted questions including the NASS patient-satisfaction index. The symptom-free interval was computed by the Kaplan-Meier method. Outcome predictors such as age, sex, duration of LBP, and MR imaging findings were statistically analyzed by the Mann-Whitney U and the Fisher exact tests. RESULTS: Eighty-one patients (male/female = 16:65; mean age, 49.9 years; range, 17-77 years) were included in the study. The interlaminar ESI was effective in 63 of the 81 patients (77.8%) at initial short-term follow-up. For the 63 patients in whom ESI was effective, the median symptom-free interval was 154 days (95% CI, 96-212 days). Among 68 patients for whom telephone interviews were possible, 44 patients (64.7%) replied positively to the NASS patient satisfaction index (NASS patientsatisfaction index, 1 or 2). There were no significant outcome predictors. CONCLUSIONS: The therapeutic trial of a fluoroscopic interlaminar ESI was effective for axial LBP without significant outcome predictors.
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 (> or = 50%) was demonstrated in 74% of patients in Group I and 63% in Group II. Functional status improvement (reduction of > or = 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 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.
There is continued debate on the effectiveness, indications, and medical necessity of epidural injections in managing pain and disability from lumbar disc herniation, despite extensive utilization. There is paucity of literature on interlaminar epidural injections in managing lumbar disc herniation or radiculitis in contemporary interventional pain management settings utilizing fluoroscopy.
METHODS:
A randomized, double-blind, active-control trial was undertaken to assess the effectiveness of lumbar interlaminar epidural injections with or without steroids for disc herniation and radiculitis. The primary outcome was defined as pain relief and functional status improvement of ≥ 50%. One hundred twenty patients were randomly assigned to 1 of the 2 groups. Group I patients received lumbar interlaminar injections containing a local anesthetic (lidocaine 0.5%, 6 mL), whereas Group II patients received lumbar interlaminar epidural injections of 0.5% lidocaine, 5 mL, mixed with 1 mL of non-particulate betamethasone.
RESULTS:
In the patients who responded with initial 2 procedures with at least 3 weeks of relief, significant improvement was seen in 80% of the patients in the local anesthetic group and 86% of the patients in the local anesthetic and steroid group. The overall average procedures per year were 3.6 in the local anesthetic group and 4.1 in the local anesthetic and steroid group, with an average relief of 33.7 ± 18.1 weeks in the local anesthetic group and 39.1 ± 12.2 weeks in the local anesthetic and steroid group over a period of 52 weeks in the overall population.
CONCLUSIONS:
Lumbar interlaminar epidural injections of local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis, with potential superiority of steroids compared with local anesthetic alone at 1 year follow-up.
