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: Arthroscopic partial meniscectomy is one of the most common orthopedic procedures, yet rigorous evidence of its efficacy is lacking.
METHODS: We conducted a multicenter, randomized, double-blind, sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis. Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery. The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100, with lower scores indicating more severe symptoms) and in knee pain after exercise (rated on a scale from 0 to 10, with 0 denoting no pain) at 12 months after the procedure.
RESULTS: In the intention-to-treat analysis, there were no significant between-group differences in the change from baseline to 12 months in any primary outcome. The mean changes (improvements) in the primary outcome measures were as follows: Lysholm score, 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group (between-group difference, -1.6 points; 95% confidence interval [CI], -7.2 to 4.0); WOMET score, 24.6 and 27.1 points, respectively (between-group difference, -2.5 points; 95% CI, -9.2 to 4.1); and score for knee pain after exercise, 3.1 and 3.3 points, respectively (between-group difference, -0.1; 95% CI, -0.9 to 0.7). There were no significant differences between groups in the number of patients who required subsequent knee surgery (two in the partial-meniscectomy group and five in the sham-surgery group) or serious adverse events (one and zero, respectively).
CONCLUSIONS: In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure. (Funded by the Sigrid Juselius Foundation and others; ClinicalTrials.gov number, NCT00549172.).
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 significat pain releif 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.
CLINICAL TRIAL: NCT01071369.
BACKGROUND: Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, there is a paucity of literature concerning the treatment of spinal stenosis symptoms. Multiple interventions, including surgery and interventional techniques such as epidural injections and adhesiolysis, are commonly utilized in managing pain related to central spinal stenosis. However, there is a paucity of literature from randomized, controlled trials about the effectiveness of epidural injections for lumbar central spinal stenosis.
OBJECTIVE: This study sought to assess the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief for the management of chronic low back pain related to lumbar central stenosis.
STUDY DESIGN: A randomized, double-blind, active-controlled trial.
METHODS: One hundred patients were randomly assigned to one of 2 groups, with Group I patients receiving caudal epidural injections 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, 6 mg (non-particulate betamethasone).
OUTCOMES ASSESSMENT: Multiple outcome measures, including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake were utilized. Assessments were carried out at 3, 6, 12, 18, and 24 months posttreatment. The primary outcome was defined as pain relief and improvement in disability scores of 50% or more. Successful treatment was considered as at least 3 weeks of relief following the first 2 injections, categorizing these patients into a successful group, and others into a failed group.
RESULTS: Significant pain relief and functional status improvement were seen in 51% in Group I and 57% in Group II at the end of 2 years in the successful group when the participants were separated into successful and failed groups. However, overall, significant pain relief and functional status improvement (≥ 50%) was demonstrated in 38% in Group I and 44% in Group II at the end of 2 years. The overall number of procedures for 2 years were 4 in both groups, with 5 procedures on average in the successful groups, and approximately 60 weeks of relief in Group I and 54 weeks of relief in Group II at 2 years in the successful group.
CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids provide relief in a modest proportion of patients undergoing the treatment and may be considered as an effective treatment for a select group of patients who have chronic function-limiting low back and lower extremity pain secondary to central spinal stenosis.
STUDY DESIGN: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome.
METHODS: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures.
RESULTS: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years.
CONCLUSION: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
STUDY DESIGN: A randomized, double-blind, active controlled trial.
OBJECTIVE: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis.
SUMMARY OF BACKGROUND DATA: Epidural injections in managing chronic neck and upper extremity pain are commonly employed interventions. However, their long-term effectiveness, indications, and medical necessity, of their use and their role in various pathologies responsible for persistent neck and upper extremity pain continue to be debated, even though, neck and upper extremity pain secondary to disc herniation and radiculitis, is described as the common indication. There is also paucity of high quality literature.
METHODS: One-hundred twenty 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 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. Primary outcome measure was ≥ 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight.
RESULTS: Significant pain relief and functional status improvement (≥ 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group.
CONCLUSIONS: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis.
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.
BACKGROUND: Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy.
OBJECTIVE: To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy.
DESIGN: A multicenter, 3-group, randomized, placebo-controlled trial conducted from 2008 to 2011. Randomization was computer-generated and stratified by site. Pharmacists prepared the syringes. Patients, treating physicians, and nurses assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00733096)
SETTING: Military and civilian treatment centers.
PATIENTS: 84 adults with lumbosacral radiculopathy of less than 6 months' duration.
INTERVENTION: 2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks.
MEASUREMENTS: The primary outcome measure was leg pain 1 month after the second injection. All patients had 1-month follow-up visits; patients whose condition improved remained blinded for the 6-month study period.
RESULTS: The group that received epidural steroids had greater reductions in the primary outcome measure than those who received saline (mean difference, -1.26 [95% CI, -2.79 to 0.27]; P = 0.11) or etanercept (mean difference, -1.01 [CI, -2.60 to 0.58]; P = 0.21). For back pain, smaller differences favoring steroids compared with saline (mean difference, -0.52 [CI, -1.85 to 0.81]; P = 0.44) and etanercept (mean difference, -0.92 [CI,-2.28 to 0.44]; P = 0.18) were observed. The largest differences were noted for functional capacity, in which etanercept fared worse than the other treatments: steroids vs. etanercept (mean difference, -16.16 [CI, -26.05 to -6.27]; P = 0.002), steroids vs. saline (mean difference, -5.87 [CI, -15.59 to 3.85]; P = 0.23), and etanercept vs. saline (mean difference, 10.29 [CI, 0.55 to 20.04]; P = 0.04). More patients treated with epidural steroids (75%) reported 50% or greater leg pain relief and a positive global perceived effect at 1 month than those who received saline (50%) or etanercept (42%) (P = 0.09).
LIMITATION: Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept.
CONCLUSION: Epidural steroid injections may provide modest short-term pain relief for some adults with lumbosacral radiculopathy, but larger studies with longer follow-up are needed to confirm their benefits.
PRIMARY FUNDING SOURCE: The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.
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.
TRIAL REGISTRATION: NCT0037079.
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.
