Project description:ObjectiveTo evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy.DesignA multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes.SettingsEight military, Veterans Administration, and civilian hospitals.Participants145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain.InterventionsParticipants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin.Main outcome measuresAverage leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥ 2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit.ResultsThere were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments.ConclusionsAlthough epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier: NCT01495923.
Project description:ObjectivesEpidural steroid injections (ESIs) can be used to reduce lumbosacral radicular syndrome (LRS) related pain. The clinical relevance of ESIs are currently unknown. This systematic review and meta-analyses aims to assess whether ESIs are clinically relevant for patients with LRS.Materials and methodsComprehensive literature searches for randomized controlled trials regarding steroid injections for LRS were conducted in PudMed, EMBASE, CINAHL, and CENTRAL from their inception to September 2018 (December 2019 for PubMed). For each homogenous comparison, the outcomes function, pain intensity and health-related quality of life at different follow-up intervals were pooled separately. The GRADE approach was used to determine the overall certainty of the evidence.ResultsSeventeen studies were included. Two different homogenous comparisons were identified for which the randomized controlled trials could be pooled. In 36 of the 40 analyses no clinically relevant effect was found. The certainty of evidence varied between very low to high. Four analyses found a clinically relevant effect, all on pain intensity and health-related quality of life, but the certainty of the evidence was either low or very low. Two of the 33 subgroup analyses showed a clinically relevant effect. However, according to the GRADE approach the certainty of these findings are low to very low.DiscussionOn the basis of the analyses we conclude there is insufficient evidence that ESIs for patients with LRS are clinically relevant at any follow-up moment. High-quality studies utilizing a predefined clinical success are necessary to identify potential clinically relevant effects of ESIs. Until the results of these studies are available, there is reason to consider whether the current daily practice of ESIs for patients with LRS should continue.
Project description:ObjectiveThis study aimed to compare parasagittal interlaminar (PS) and transforaminal (TF) epidural steroid injections for unilateral L5 and S1 radicular lower back pain in terms of patient comfort, efficacy, safety, contrast enhancement, and radiation exposure.MethodsThis was a prospective randomized single-blind study. A total of 59 participants were included in this study. The visual analog scale (VAS) and Oswestry Disability Index (ODI) were obtained. A comfort questionnaire was administered to all participants. The total fluoroscopy time and contrast distribution levels were recorded.ResultsPre- and post-treatment VAS scores were similar between the groups. The ODI scores increased in favor of the PS group at week 2 (P < 0.041); however, there was no difference between the two groups at other times. The VAS and ODI scores improved significantly with treatment in both the groups (P < 0.001). Total fluoroscopy time was shorter in the PS group (P < 0.001). PS application was more comfortable (P < 0.001). While no complications were observed in the PS group, three complications occurred in the TF group. Anterior epidural contrast spread to three or more levels was observed in 57% of the participants in the PS group, whereas no spread to more than two levels was observed in the TF group.ConclusionThe PS epidural approach is superior to the TF approach in terms of a low incidence of side effects, less radiation exposure, better patient comfort, higher epidural contrast spread, and single-level needle access.
Project description:BackgroundPrevious systemic reviews have examined the efficacy of individual therapeutic agents, but which type of treatment is superior to another has not been pooled or analyzed. The objective of the current study was to compare the clinical effectiveness of epidural steroid injection (ESI) versus conservative treatment for patients with lumbosacral radicular pain.MethodsA systematic search was conducted with MEDLINE, EMBASE, and CENTRAL databases with a double-extraction technique for relevant studies published between 2000 and January 10, 2019. The randomized controlled trials which directly compared the efficacy of ESI with conservative treatment in patients with lumbosacral radicular pain were included. Outcomes included visual analog scale, numeric rating scale, Oswetry disability index, or successful events. Two reviewers extracted data and evaluated the methodological quality of papers using the Cochrane Collaboration Handbook. A meta-analysis was performed using Revman 5.2 software. The heterogeneity of the meta-analysis was also assessed.ResultsOf 1071 titles initially identified, 6 randomized controlled trials (249 patients with ESI and 241 patients with conservative treatment) were identified and included in this meta-analysis. The outcome of the pooled analysis showed that ESI was beneficial for pain relief at short-term and intermediate-term follow-up when compared with conservative treatment, but this effect was not maintained at long-term follow-up. Successful event rates were significantly higher in patients who received ESI than in patients who received conservative treatment. There were no statistically significant differences in functional improvement after ESI and conservative treatment at short-term and intermediate-term follow-up. The limitations of this meta-analysis resulted from the variation in types of interventions and small sample size.ConclusionsAccording to the results of this meta-analysis, the use of ESI is more effective for alleviating lumbosacral radicular pain than conservative treatments in terms of short-term and intermediate-term. Patients also reported more successful outcomes after receiving ESI when compared to conservative treatment. However, this effect was not maintained at long-term follow-up. This meta-analysis will help guide clinicians in making decisions for the treatment of patients with lumbosacral radicular pain, including the use of ESI, particularly in the management of pain at short-term.
Project description:ObjectiveTo observe the contrast spread in superoposterior transforaminal epidural steroid injection (SP TFESI) and investigate the correlation between spread patterns and efficacy.MethodsThirty-one patients with lumbosacral radiculopathy underwent single-level TFESI under fluoroscopy. The final needle tip position was targeted toward the SP quadrant of the intervertebral foramen. To observe the spread, 1 mL of contrast material was injected, followed by a steroid injection. The contrast spread was graded anteroposteriorly and vertically in the epidural space. The effect of SP TFESI was evaluated by proportional pain score reduction.ResultsLevels injected were L4-5 (n=20) and L5-S1 (n=11). Seventeen cases were lateral, and 14 were central herniated disc (HD). Baseline mean visual analog scale score was 6.23. Contrast dispersed dorsally in all the cases, and 45.2% cases showed a concurrent ventral spread. The proportion of the pain reduction after 2 weeks showed no difference between the two groups. In vertical spreading analysis, mean cephalic/caudal grades were 1.40/1.55 at L4-5 level and 1.73/1.64 at L5-S1 level. The HD location had no effect on contrast dispersion.ConclusionIn SP TFESI, ventral contrast spread did not guarantee a better effect; however, the extent of cephalic flow in ventral expansion group correlated with the proportion of pain reduction.
Project description:PurposeSP-102 is a novel epidural steroid injection (ESI) formulation of 10 mg dexamethasone sodium phosphate in a viscous gel solution. Repeat dosing of ESIs is possible if required for pain relief, but with consideration of hypothalamic-pituitary-adrenal (HPA) axis suppression from prolonged systemic exposure. This phase I/II study investigated the effect of initial and repeat SP-102 injections on HPA suppression and analgesia.MethodsSubjects with lumbosacral radiculopathy received an initial epidural SP-102 injection (T1) on day 1, followed by a repeat injection (T2) on ≥28 days later. To determine HPA suppression, area under the effect curve over 28 days and maximum change from baseline were calculated for cortisol, glucose levels, and white blood cell (WBC) count. Equivalent effect on HPA suppression of T1 relative to T2 was determined if the 90% CIs for ratios of these measures were within 80%-125%. The effect of repeat injections on leg and back pain was also assessed.ResultsBased on the responder analysis, all subjects had achieved a cortisol response by day 3 after initial injection and by day 2 after repeat injection. The repeat injection had similar effects on glucose levels and WBC count to the initial injection. Pain scores decreased after each injection and remained low for the 28-day follow-up, with some evidence of improved analgesic effect of the second dose compared with the first. There were no serious adverse events or discontinuations due to adverse events.ConclusionThe lack of cumulative effect and rapid resolution of HPA suppression following repeated SP-102 dosing suggests that consideration of HPA pharmacodynamics is not clinically relevant when making decisions regarding repeat dosing. SP-102 ESIs provided prolonged pain relief, with preliminary evidence of greater efficacy after repeat injection. A phase III trial is ongoing.Clinical trial identifierClinicalTrials.gov: NCT03613662.
Project description:The management of patients with lumbosacral radicular pain (LRP) is of primary importance to healthcare professionals. This study aimed to: identify international clinical practice guidelines on LRP, assess their methodological quality, and summarize their diagnostic and therapeutic recommendations. A systematic search was performed (August 2019) in MEDLINE, PEDro, National Guideline Clearinghouse, National Institute for Health and Clinical Excellence (NICE), New Zealand Guidelines Group (NZGG), International Guideline Library, Guideline central, and Google Scholar. Guidelines presenting recommendations on diagnosis and/or treatment of adult patients with LRP were included. Two independent reviewers selected eligible guidelines, evaluated quality with Appraisal of Guidelines Research & Evaluation (AGREE) II, and extracted recommendations. Recommendations were classified into 'should do', 'could do', 'do not do', or 'uncertain'; their consistency was labelled as 'consistent', 'common', or 'inconsistent'. Twenty-three guidelines of varying quality (AGREE II overall assessment ranging from 17% to 92%) were included. Consistent recommendations regarding diagnosis are ('should do'): Straight leg raise (SLR) test, crossed SLR test, mapping pain distribution, gait assessment, congruence of signs and symptoms. Routine use of imaging is consistently not recommended. The following therapeutic options are consistently recommended ('should do'): educational care, physical activity, discectomy under specific circumstances (e.g., failure of conservative treatment). Referral to a specialist is recommended when conservative therapy fails or when steppage gait is present. These recommendations provide a clear overview of the management options in patients with LRP.
Project description:BackgroundThe effect of adding alpha lipoic acid (ALA) to pulsed radiofrequency (PRF) for treatment of lumbar-sacral pain was evaluated.Objectiveto evaluate the effect of using ALA as an adjuvant therapy with PRF for treatment of chronic lumbosacral radicular pain caused by herniated disc.MethodsOne hundred twenty patients with lumbo-sacral radicular pain allocated into 2 groups. Group I: treated with PRF at 42°C for 120 seconds. Group II: treated as in group I, plus oral ALA 600 mg (Thiotacid 600 mg, EVA PHARMA, Egypt) three times per day (1800 mg/day) for 3 weeks then 600 mg once daily for 2 weeks. The lumbo-sacral radicular pain evaluated using the numerical rating pain score and Oswestry Disability Index.ResultsSuccess rate was significantly higher in group II at 3 and 6 months after intervention. The median values of the numerical rating pain score and the Oswestry Disability Index were significantly lower in group II with no significant difference in Epworth Sleepiness Scale. No major complications were reported in both groups.ConclusionThe current study supports the use of ALA with PRF on the dorsal root ganglion for treating lumbosacral radicular pain.