OBJECTIVE: To determine the difference in short- and long-term pain improvement between lumbar Epidural Steroid Injections (ESIs) and conservative management in patients with lumbar radiculopathy.
STUDY DESIGN: Quasi-experimental study.
PLACE AND DURATION OF STUDY: The Postgraduate Medical Institute of Hayatabad Medical Complex, Peshawar, from April 2005 to March 2007.
METHODOLOGY: Fifty elective patients fulfilling the inclusion criteria were randomly divided into two groups. Patients in the steroid group were treated with 80 mg of methylprednisolone injected in combination with 3 ml of 2% plain xylocaine and 3 ml of normal saline in the lumbar epidural space, while patients in the conservative group were treated with bed rest, non-steroidal anti-inflammatory agents, muscle relaxants, and opioids. All the 50 patients in the two groups were regularly assessed at 2 weeks, 1 month, 3 months and 6 months of periods for pain score by the Visual Analogue Scale (VAS), patients satisfaction score and any unwanted side effects.
RESULTS: A marked improvement of the pain score and patients satisfaction score were noticed in the steroid group. Less significant improvement was seen in the conservative group during the initial period i.e 2 weeks and 1 month (p < 0.05). The difference in Visual Analogue Scale (VAS) and patients satisfaction score was non-significant in chronic stages of treatment in both groups (p > 0.05).
CONCLUSION: Epidural steroid injections in acute symptoms of sciatica are considered to be a better option compared to conservative treatment.
BACKGROUND: Lumbar facet joints have been implicated as the source of chronic pain in 15% to 45% of patients with chronic low back pain. Various therapeutic techniques including intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin.
OBJECTIVE: The study was conducted to determine the clinical effectiveness of therapeutic local anesthetic lumbar facet joint nerve blocks with or without steroid in managing chronic function-limiting low back pain of facet joint origin.
DESIGN: A randomized, double-blind, controlled trial.
SETTING: An interventional pain management setting in the United States.
METHODS: This study included 60 patients in Group I with local anesthetic and 60 patients in Group II with local anesthetic and steroid. The inclusion criteria was based on the positive response to the diagnostic controlled comparative local anesthetic lumbar facet joint blocks.
OUTCOME MEASURES: Numeric pain scores, Oswestry Disability Index, opioid intake, and work status. All outcome assessments were performed at baseline, 3 months, 6 months, and 12 months.
RESULTS: Significant improvement with significant pain relief (> 50%) and functional improvement (> 40%) were observed in 82% and 85% in Group I, with significant pain relief in over 82% of the patients and improvement in functional status in 78% of the patients. Based on the results of the present study, it appears that patients may experience significant pain relief 44 to 45 weeks of 1 year, requiring approximately 3 to 4 treatments with an average relief of 15 weeks per episode of treatment.
CONCLUSION: Therapeutic lumbar facet joint nerve blocks, with or without steroid, may provide a management option for chronic function-limiting low back pain of facet joint origin.
OBJECTIVE: Low back pain is a highly common problem and causes much morbidity and socioeconomic loss in the community. Although the use of caudal epidural injections in the management of the low back pain with radicular signs is commonplace, it has not been well investigated. We compare the effectiveness of caudal epidural injection versus non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of low back pain accompanied with radicular pain.
METHODS: The study was a controlled prospective unblinded trial. A total of consecutive 64 patients with subacute or chronic low back pain accompanied with radicular pain were included. The patients were randomly allocated to two groups. First group was caudal epidural injection plus therapeutic exercise group, and the second group was NSAIDs plus therapeutic exercise group. Patients were assessed with 10 cm visual analogue scale for pain, straight leg raising test and Oswestry low back pain disability questionnaire at the beginning and at 15th day, 1st and 3rd month.
RESULTS: It was seen that both groups' improvement were good and statistically significant. On the other hand, caudal epidural injection group's improvement was better and faster than the NSAID group's, and the differences between assessment scores of the groups were statistically significant, except the 3rd month Oswestry scores.
CONCLUSION: Finally, caudal epidural injection in the management of the subacute/chronic low back and radicular pain is a preferable choice, if applied by experienced specialists.
BACKGROUND: The prevalence of persistent low back pain with the involvement of lumbar facet or zygapophysial joints has been described in controlled studies as varying from 15% to 45% based on the criteria of the International Association for the Study of Pain. Therapeutic interventions utilized in managing chronic low back pain of facet joint origin include intraarticular injections, medial branch nerve blocks, and neurolysis of medial branch nerves.
OBJECTIVE: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain of facet joint origin.
DESIGN: A prospective, randomized, double-blind trial.
SETTING: An interventional pain management setting in the United States.
METHODS: In this preliminary analysis, data from a total of 60 patients were included, with 15 patients in each of 4 groups. Thirty patients were in a non-steroid group consisting of Groups I (control, with lumbar facet joint nerve blocks using bupivacaine ) and II (with lumbar facet joint nerve blocks using bupivacaine and Sarapin); another 30 patients were in a steroid group consisting of Groups III (with lumbar facet joint nerve blocks using bupivacaine and steroids) and IV (with lumbar facet joint nerve blocks using bupivacaine, Sarapin, and steroids). All patients met the diagnostic criteria of lumbar facet joint pain by means of comparative, controlled diagnostic blocks.
OUTCOME MEASURES: Numeric Rating Scale (NRS) pain scale, the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake.
RESULTS: Significant improvement in pain and functional status were observed at 3 months, 6 months, and 12 months, compared to baseline measurements. The average number of treatments for 1 year was 3.7 with no significant differences among the groups. Duration of average pain relief with each procedure was 14.8 +/- 7.9 weeks in the non-steroid group, and 12.5 +/- 3.3 weeks in the steroid group, with no significant differences among the groups.
CONCLUSION: Therapeutic lumbar facet joint nerve blocks with local anesthetic, with or without Sarapin or steroids, may be effective in the treatment of chronic low back pain of facet joint origin.
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.
STUDY DESIGN: A randomized, double-blind controlled trial.
OBJECTIVES: To determine the treatment effect of corticosteroids in periradicular infiltration for chronic radicular pain. We also examined prognostic factors in relation to the outcome of the procedure.
SUMMARY OF BACKGROUND DATA: Various studies have examined the therapeutic value of periradicular infiltration using treatment agents consisting of local anesthetic and corticosteroids for radicular pain, secondary to lumbar disc herniation and spinal stenosis. There is currently no randomized trial to determine the efficacy of a single injection of corticosteroids for chronic radicular pain.
METHODS: Eligible patients with radicular pain who had unilateral symptoms who failed conservative management were randomized for a single injection with bupivacaine and methylprednisolone or bupivacaine only. Outcome measures included the Oswestry Disability Index, visual analogue score for back pain and leg pain, claudication walking distance, and the patient's subjective level of satisfaction of the outcome.
RESULTS: We recruited 43 patients in the bupivacaine and methylprednisolone group and 43 patients in the bupivacaine only group. The follow-up rate is 100%. Five patients had early termination of the trial for discectomy and further root block. There is no statistically significant difference in the outcome measures between the groups at 3 months (change of the Oswestry Disability Index [P = 0.68], change in visual analogue score [back pain, P = 0.68; leg pain, P = 0.94], change in walking distance [P = 0.7]). Duration of symptoms has a statistically significant negative association with the change in Oswestry Disability Index (P = 0.03).
CONCLUSION: Clinical improvement occurred in both groups of patients. Corticosteroids did not provide additional benefit.
STUDY DESIGN: A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies.
OBJECTIVES: To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR.
SUMMARY OF BACKGROUND DATA: Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome.
METHODS: From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly allocated comparison group (Group B, n = 34) undergoing exercises alone in a single-blind design. Physical therapists saw patients an average of twice per week, providing supervision of a progressive home stretching program. Inclinometric joint ROM was measured at the time of group allocation, and again 5 to 7 weeks later. Validated questionnaires of pain (intensity VAS) and disability (Million VAS) related to the CDWRLSD were provided before and after the interventions.
RESULTS: Part 1 reliability and facet syndrome prevalence work revealed that interrater reliability for experienced examiners to detect rigid segments was excellent (Pearson's r = 0.97, P < 0.01). Intrarater 3-joint motion measurement reliability was also good for all sagittal/coronal ROM (Pearson's r = 0.95-0.99, P < 0.01). Only 5 of 29 subjects with SR met criteria for facet syndrome (17%), consistent with prior prevalence studies of unselected patients with low back pain. In Part 2, a large majority of patients in both groups improved from the initial to the post-treatment ROM measurements (the primary outcome criterion of the study). However, a higher proportion of Group A (injection) patients (87%-95%) showed ROM improvement, compared to Group B (exercise only) patients (64%-79%). Group A patients showed a significantly greater ROM improvement in all sagittal and coronal movements, both in absolute terms and percent of initial measurement. No significant differences in pain or disability self-report were found between groups, pre- or postintervention, but both groups showed significant improvement from pre- to postintervention in pain and disability assessments.
CONCLUSIONS: The detection of SR and measurement of 3-segment true lumbar ROM by experienced examiners is highly reliable. Only 17% of CDWRLSD patients with lumbar SR met criteria for the facet syndrome, a rate approximately equal to that of unselected low back pain cohorts. This indicates that lumbar SR may be found whether or not pain of facet joint origin is present. In the randomized trial, facet injections significantly increased the percentage of patients with SR showing ROM improvement, as well as the degree of improvement in lumbar mobility after treatment. There is no evidence that facet injections increase the improvements in pain/disability report noted in both groups.
OBJECTIVE: To evaluate the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) combination tablets for treatment of chronic low back pain (LBP).
METHODS: This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for > or = 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores > or = 40/100 mm] after washout were randomized to tramadol/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments.
RESULTS: In total, 336 intent-to-treat patients received tramadol/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for tramadol/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form-36 Health Survey were significantly better for tramadol/APAP patients. More patients rated tramadol/APAP as "very good" or "good" than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (tramadol/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with tramadol/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of tramadol/APAP was 4.2 tablets (tramadol 158 mg/APAP 1369 mg).
CONCLUSION: Tramadol 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP.