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Journal Journal of Neurological Sciences (Turkish)
Year
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OBJECTIVE:The purpose of this study is to determine the efficacy and safety of unilateral laminotomy for decompression of lumbar stenosis (LS). Although minimally invasive procedures are gaining increasing popularity in the treatment of spinal disorders, minimally invasive techniques are not standard in the surgical treatment of lumbar stenosis yet.METHODS:Fifty-two consecutive patients with lumbar stenosis were randomized to two treatment groups (unilateral laminotomy for decompression-Group 1, decompressive laminectomy-Group 2). Maximum walking distance (MWD), Oswestry Disability Index (ODI), spinal MRI and CT, and flexion-extension radiography were used to assess clinical outcome, adequacy of decompression and postoperative instability.RESULTS:Excellent-good clinical outcome was obtained in 88% of patients in Group 1 and in 69% of patients in Group 2. Increase in MWD and dural sac area after surgery were adequate in both groups. Postoperative spinal instability occurred in five patients in Group 2, none in Group 1. There was no surgical complication in the groups.CONCLUSIONS:Unilateral laminotomy for decompression is an effective and safe technique for treatment of LS. This technique ensures adequate decompression and good clinical outcome. It does not cause spinal instability.

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Journal Pain physician
Year 2015
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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. CLINICAL TRIAL: NCT00681447.

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BACKGROUND: Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis, a common cause of pain and disability in older adults. However, rigorous data are lacking regarding the effectiveness and safety of these injections. METHODS: In a double-blind, multisite trial, we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The patients received one or two injections before the primary outcome evaluation, performed 6 weeks after randomization and the first injection. The primary outcomes were the score on the Roland-Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability) and the rating of the intensity of leg pain (on a scale from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine"). RESULTS: At 6 weeks, there were no significant between-group differences in the RMDQ score (adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group, -1.0 points; 95% confidence interval [CI], -2.1 to 0.1; P = 0.07) or the intensity of leg pain (adjusted difference in the average treatment effect, -0.2 points; 95% CI, -0.8 to 0.4; P = 0.48). A prespecified secondary subgroup analysis with stratification according to type of injection (interlaminar vs. transforaminal) likewise showed no significant differences at 6 weeks. CONCLUSIONS: In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. Copyright © 2014 Massachusetts Medical Society.

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Journal Pain practice : the official journal of World Institute of Pain
Year 2013
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.

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Journal Spine
Year 2013
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Study Design. Prospective, randomized controlled studyObjective. To compare the functional outcomes and extent of paraspinal muscle damage between two decompressive techniques for lumbar canal stenosis (LCS).Summary of Background Data. Lumbar spinous process splitting decompression (LSPSD) preserves the muscular and ligamentous attachments of the posterior elements of the spine. It can potentially avoid problems like paraspinal muscle atrophy and trunk extensor weakness that can occur following conventional midline decompression (CMD). However large series prospective randomized controlled studies are lacking.Methods. Patients with LCS were randomly allocated into two groups: LSPSD (28 patients) and CMD (23 patients). The differences in operative time, blood loss, time to comfortable mobilization and hospital stay were studied. Paraspinal muscle damage was assessed by post operative rise in CPK and CRP levels. Functional outcome was evaluated at one year by JOA score, NCOS, VAS for Back pain and Neurogenic Claudication.Results. 51 patients of mean age 56 years were followed up for a mean 14.2 ± 2.9 months. There were no significant differences in the operative time, blood loss, and hospital stay. Both the groups showed significant improvement in the functional outcome scores at one year. Between the two groups, the JOA score, NCOS improvement, BPVAS, NCVAS and the post-operative changes in serum CRP and CPK levels did not show any statistically significant difference. Based on JOA recovery rate, 73.9% of CMD group had good outcomes compared to only 60.7% after LSPSD.Conclusion. The functional outcome scores, back pain and claudication pain in the immediate period and at the end of one year are similar in both the techniques. More patients had better functional outcomes after conventional decompression than the LSPSD technique. Based on the present study, the superiority of one technique over the other is not established mandating the need for further long term studies.

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STUDY DESIGN: Survey based on complication scenarios. OBJECTIVE: To assess and compare perceived potential impacts of various perioperative adverse events by both surgeons and patients. SUMMARY OF BACKGROUND DATA: Incidence of adverse events after adult spinal deformity surgery remains substantial. Patient-centered outcomes tools measuring the impact of these events have not been developed. An important first step is to assess the perceptions of surgeons and patients regarding the impact of these events on surgical outcome and quality of life. METHODS: Descriptions of 22 potential adverse events of surgery (heart attack, stroke, spinal cord injury, nerve root injury, cauda equina injury, blindness, dural tear, blood transfusion, deep vein thrombosis, pulmonary embolism, superficial infection, deep infection, lung failure, urinary tract infection, nonunion, adjacent segment disease, persistent deformity, implant failure, death, renal failure, gastrointestinal complications, and sexual dysfunction) were presented to 14 spinal surgeons and 16 adult patients with spinal deformity. Impact scores were assigned to each complication on the basis of perceptions of overall severity, satisfaction with surgery, and effect on quality of life. Impact scores were compared between surgeons and patients with a Wilcoxon/Kruskal-Wallis test. RESULTS: Mean impact scores varied from 0.9 (blood transfusion) to 10.0 (death) among surgeons and 2.3 (urinary tract infection) to 9.2 (stroke) among patients. Patients' scores were consistently higher (P < 0.05) than surgeons in all 3 categories for 6 potential adverse events: stroke, lung failure, heart attack, pulmonary embolism, dural tear, and blood transfusion. Three additional complications (renal failure, non-union, and deep vein thrombosis) were rated higher in 1 or 2 categories by patients. CONCLUSION: There was substantial variation in how both surgeons and patients perceived impacts of various adverse events after spine surgery. Patients generally perceived the impact of adverse events to be greater than surgeons. Patient-centered descriptions of adverse events would provide a more complete description of surgical outcomes.

Primary study

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Journal Spine
Year 2013
STUDY DESIGN: Subgroup analysis of prospective, randomized database from the Spine Patient Outcomes Research Trial (SPORT). OBJECTIVE: The hypothesis of this study was that patients who received ESI during initial treatment as part of SPORT (The Spine Patient Outcomes Research Trial) would have improved clinical outcome and a lower rate of crossover to surgery than patients who did not receive ESI. SUMMARY OF BACKGROUND DATA: The use of epidural steroid injection (ESI) in patients with lumbar spinal stenosis is common, although there is little evidence in the literature to demonstrate its long-term benefit in the treatment of lumbar stenosis. METHODS: Patients with lumbar spinal stenosis who received ESI within the first 3 months of enrollment in SPORT (ESI) were compared with patients who did not receive epidural injections during the first 3 months of the study (no-ESI). RESULTS: There were 69 ESI patients and 207 no-ESI patients. There were no significant differences in demographic factors, baseline clinical outcome scores, or operative details between the groups, although there was a significant increase in baseline preference for nonsurgical treatment among ESI patients (ESI 62% vs. no-ESI 33%, P < 0.001). There was an average 26-minute increase in operative time and an increased length of stay by 0.9 days among the ESI patients who ultimately underwent surgical treatment. Averaged over 4 years, there was significantly less improvement in 36-Item Short Form Health Survey (SF-36) Physical Function among surgically treated ESI patients (ESI 14.8 vs. no-ESI 22.5, P = 0.025). In addition, there was significantly less improvement among the nonsurgically treated patients in SF-36 Body Pain (ESI 7.3 vs. no-ESI 16.7, P = 0.007) and SF-36 Physical Function (ESI 5.5 vs. no-ESI 15.2, P = 0.009). Of the patients assigned to the surgical treatment group, there was a significantly increased crossover to nonsurgical treatment among patients who received an ESI (ESI 33% vs. no-ESI 11%, P = 0.012). Of the patients assigned to the nonoperative treatment group, there was a significantly increased crossover to surgical treatment in the ESI patients (ESI 58% vs. no-ESI 32%, P = 0.003). CONCLUSION: Despite equivalent baseline status, ESIs were associated with significantly less improvement at 4 years among all patients with spinal stenosis in SPORT. Furthermore, ESIs were associated with longer duration of surgery and longer hospital stay. There was no improvement in outcome with ESI whether patients were treated surgically or nonsurgically.

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Authors Brown LL
Journal Pain practice : the official journal of World Institute of Pain
Year 2012
BACKGROUND: Epidural steroid injections (ESIs) are commonly used to treat low back pain, including symptomatic lumbar spinal stenosis (LSS). Reports on LSS treatment with ESIs have not differentiated between neurogenic claudication, which is believed to result from nerve root compression, and lumbar radicular pain, thought to be caused by inflammation. While there is overlap between these groups, the clinical relevance of ESI treatment cannot be generalized between these 2 distinct diseases with completely different pathophysiological causes. METHODS: This was a double-blind, randomized, prospective study of ESI vs. the mild procedure in patients with symptomatic LSS, conducted at a single pain management center. Patient reported outcome measures included Visual Analog Scale, Oswestry Disability Index, and Zurich Claudication Questionnaire (ZCQ) patient satisfaction. RESULTS: Thirty-eight patients were randomized into 2 treatment groups, 21 in mild and 17 in ESI. At 6- and 12-week follow-up, patients treated with mild reported significantly greater pain decrease over time (P < 0.0001), and significantly greater functional mobility improvement over time (P < 0.0018) than ESI patients. At week 6, mild ZCQ patient satisfaction score of 2.2 indicated a higher level of satisfaction than for ESI with a score of 2.8. In addition, 12-week ZCQ satisfaction score was 1.8, demonstrating sustained near-term satisfaction in the mild group. No major mild or ESI device or procedure-related complications were reported. CONCLUSIONS: This study demonstrated that in LSS patients suffering with neurogenic claudication, mild provides statistically significantly better pain reduction and improved functional mobility vs. treatment with ESI.

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Journal Journal of pain research
Year 2012
Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. 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 discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source. © 2012 Manchikanti et al, publisher and licensee Dove Medical Press Ltd.

Primary study

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Journal Pain physician
Year 2012
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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.