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: 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.
OBJECTIVE: To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks).
DESIGN: Multicentre, blinded, randomised controlled trial.
SETTING: Outpatient multidisciplinary back clinics of five Norwegian hospitals.
PARTICIPANTS: Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity.
INTERVENTIONS: Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval.
MAIN OUTCOME MEASURES: Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain.
RESULTS: Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n = 40), estimated change in the Oswestry disability index from the adjusted baseline value was -4.7 (95% confidence intervals -0.6 to -8.8) at 6 weeks, -11.4 (-6.3 to -14.5) at 12 weeks, and -14.3 (-10.0 to -18.7) at 52 weeks. For the epidural saline intervention group (n = 39) compared with the sham group, differences in primary outcome were -0.5 (-6.3 to 5.4) at 6 weeks, 1.4 (-4.5 to 7.2) at 12 weeks, and -1.9 (-8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were -2.9 (-8.7 to 3.0), 4.0 (-1.9 to 9.9), and 1.9 (-4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend.
CONCLUSIONS: Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy. Trial registration Current Controlled Trials ISRCTN No 12574253.
BACKGROUND: Post lumbar surgery syndrome represents a cluster of nomenclature and syndromes following spine surgery wherein the expectations of the patient and spine surgeon are not met, with persistent pain following lumbar surgery. Multiple causes have been speculated to cause pain after lumbar surgery. Epidural steroid injections are most commonly used in managing post surgical pain in the lumbar spine. However, there is a paucity of evidence of epidural injections in managing chronic low back pain with or without lower extremity pain in post surgery syndrome.
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 in patients with chronic low back and lower extremity pain after surgical intervention with post lumbar surgery syndrome.
METHODS: One-hundred forty 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 6 mg non-particulate Celestone. 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 and disability reduction were described as 50% or more reduction in scores from baseline.
RESULTS: Combined pain relief (>/=50%) and disability reduction was recorded in 53% of the patients in the local anesthetic group, and 59% of patients in the local anesthetic and steroid group with no significant differences noted with or without steroid over a period of one-year. However, the data from the successful group showed improvement in 70% of patients in Group I and 75% of patients in Group II. The average procedures per year were 4 with an average total relief per year of 38.1 ± 14.5 weeks in Group I and 38.4 ± 13.2 weeks in Group II over a period of 52 weeks in the successful group.
LIMITATIONS: The results of this study are limited by the lack of a placebo group and one-year outcomes.
CONCLUSION: Caudal epidural injections in chronic function-limiting low back pain in post surgery syndrome without facet joint pain may be effective in a significant proportion of patients with improvement in functional status and significant pain relief.
CLINICAL TRIAL: NCT00370799.
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: Transforaminal injection of steroids is used to treat lumbar radicular pain. Not known is whether the route of injection or the agent injected is significant.
STUDY DESIGN: A prospective, randomized study compared the outcomes of transforaminal injection of steroid and local anesthetic, local anesthetic alone, or normal saline, and intramuscular injection of steroid or normal saline. Patients and outcome evaluators were blinded as to agent administered.
METHODS: The primary outcome measure was the proportion of patients who achieved complete relief of pain, or at least 50% relief, at 1 month after treatment. Secondary outcome measures were function, disability, patient-specified functional outcomes, use of other health care, and duration of relief beyond 1 month.
RESULTS: A significantly greater proportion of patients treated with transforaminal injection of steroid (54%) achieved relief of pain than did patients treated with transforaminal injection of local anesthetic (7%) or transforaminal injection of saline (19%), intramuscular steroids (21%), or intramuscular saline (13%). Relief of pain was corroborated by significant improvements in function and disability, and reductions in use of other health care. Outcomes were equivalent for patients with acute or chronic radicular pain. Over time, the number of patients who maintained relief diminished. Only some maintained relief beyond 12 months. The proportions of patients doing so were not significantly different statistically between groups.
DISCUSSION: Transforaminal injection of steroids is effective only in a proportion of patients. Its superiority over other injections is obscured when group data are compared but emerges when categorical outcomes are calculated. Over time, the proportion of patients with maintained responses diminishes.
OBJECTIVE: To determine the effectiveness and predictors of response to lumbar epidural corticosteroid injections (ESI) in patients with sciatica. We performed a 12-month, multicentre, double-blind, randomized, placebo-controlled, parallel-group trial in four secondary pain-care clinics in the Wessex Region.
METHODS: Two hundred and twenty-eight patients with a clinical diagnosis of unilateral sciatica of 1-18 months' duration were randomized to either three lumbar ESIs of triamcinolone acetonide or interligamentous saline injections at intervals of 3 weeks. The main outcome measure was the Oswestry low back pain disability questionnaire (ODQ).
RESULTS: At 3 weeks, the ESI group demonstrated a transient benefit over the placebo group (patients achieving a 75% improvement in ODQ, 12.5 vs 3.7%; number needed to treat, 11.4). No benefit was demonstrated from 6 to 52 weeks. ESIs did not improve physical function, hasten return to work or reduce the need for surgery. There was no benefit of repeated ESIs over single injection. No clinical predictors of response were found. At the end of the study the majority of patients still had significant pain and disability regardless of intervention.
CONCLUSIONS: In this pragmatic study, ESIs offered transient benefit in symptoms at 3 weeks in patients with sciatica, but no sustained benefits in terms of pain, function or need for surgery. Sciatica is a chronic condition requiring a multidisciplinary approach. To fully investigate the value of ESIs, they need to be evaluated as part of a multidisciplinary approach.
We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery. There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar.
BACKGROUND: Although epidural corticosteroid injections are commonly used for sciatica, their efficacy has not been established.
METHODS: In a randomized, double-blind trial, we administered up to three epidural injections of methylprednisolone acetate (80 mg in 8 ml of isotonic saline) or isotonic saline (1 ml) to 158 patients with sciatica due to a herniated nucleus pulposus. All patients had Oswestry disability scores higher than 20 (on a scale of 1 to 100, with scores of 20 or less indicating minimal disability, and higher scores greater disability).
RESULTS: At three weeks, the Oswestry score had improved by a mean of -8.0 in the methylprednisolone group and -5.5 in the placebo group (95 percent confidence interval for the difference, -7.1 to 2.2). Differences in improvements between the groups were not significant, except for improvements in the finger-to-floor distance (P=0.006) and sensory deficits (P=0.03), which were greater in the methylprednisolone group. After six weeks, the only significant difference was the improvement in leg pain, which was greater in the methylprednisolone group (P=0.03). After three months, there were no significant differences between the groups. The Oswestry score had improved by a mean of -17.3 in the methylprednisolone group and -15.4 in the placebo group (95 percent confidence interval for the difference, -9.3 to 5.4). At 12 months, the cumulative probability of back surgery was 25.8 percent in the methylprednisolone group and 24.8 percent in the placebo group (P=0.90).
CONCLUSIONS: Although epidural injections of methylprednisolone may afford short-term improvement in leg pain and sensory deficits in patients with sciatica due to a herniated nucleus pulposus, this treatment offers no significant functional benefit, nor does it reduce the need for surgery.
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.
