Project description:ObjectivesAmid a political agenda for integrated, high-value care, the UK is implementing its Low Back and Radicular Pain Pathway. To align care with need, it is imperative to understand the patients' perspective. The purpose of this study was, therefore, to explore how people experience being managed for sciatica within an National Health Service (NHS) pathway.DesignQualitative interpretative study.SettingMusculoskeletal Service in an NHS, Primary Care Trust, UK.ParticipantsThe sample comprised 14 people aged ≥18 years with a clinical presentation of sciatica, who were currently under the care of a specialist physiotherapist (the specialist spinal triage practitioner), had undergone investigations (MRI) and received the results within the past 6 weeks. People were excluded if they had previously undergone spinal surgery or if the suspected cause of symptoms was cauda equina syndrome or sinister pathology. Participants were sampled purposively for variation in age and gender. Data were collected using individual semi-structured interviews (duration: 38-117 min; median: 82.6 min), which were audio-recorded and transcribed verbatim. Data were analysed thematically.ResultsA series of problems with the local pathway (insufficient transparency and information; clinician-led decisions; standardised management; restricted access to specialist care; and a lack of collaboration between services) made it difficult for patients to access the management they perceived necessary. Patients were therefore required to be independent and proactive or have agency. This was, however, difficult to achieve (due to the impact of sciatica and because patients lacked the necessary skills, funds and support) and together with the pathway issues, this negated patients' capability to manage sciatica.ConclusionsThis novel paper explores how patients experience the process of being managed within a sciatica pathway. While highlighting the need to align with recommended best practice, it shows the need to be more person-centred and to support and empower patient agency.Trial registration numberClinicalTrials.gov reference (UOS-2307-CR); Pre-results.
Project description:IntroductionAcute sciatica (symptom duration less than 4 weeks), a major cause of pain and disability, is a common presentation to medical practices and hospital emergency departments. Selective CT fluoroscopy transforaminal epidural steroid injection is often used with the hope of reducing pain and improving function. Recently, there has been interest in using systemic corticosteroids in acute sciatica. However, there is limited evidence to inform management of selective CT fluoroscopy transforaminal epidural steroid in subacute and chronic sciatica and there is no evidence in acute sciatica, even though the practice is widespread. There is also limited evidence for the use of systemic corticosteroids in acute sciatica. Furthermore, the management of selective CT fluoroscopy transforaminal epidural steroid versus systemic steroids has never been directly studied.Methods and analysisSCIATICA is a pilot/feasibility study of patients with acute sciatica designed to evaluate the feasibility of undertaking a blinded four-arm randomised controlled intervention study of (1) selective CT fluoroscopy transforaminal epidural steroid (arm 1), (2) selective CT fluoroscopy transforaminal epidural saline (arm 2), (3) 15 days tapering dose of oral steroids (arm 3) and (4) a sham epidural and oral placebo control (arm 4). This feasibility study is designed to evaluate head-to-head, route versus pharmacology of interventions. The primary outcome measure is the Oswestry Disability Index (ODI) at 3 weeks. Secondary outcome is the ODI at 48 weeks. Other outcomes include numerical rating scale for leg pain, Pain DETECT Questionnaire, quality of life, medication use, rescue procedures or surgery, and adverse events. Results of outcomes from this randomised controlled trial will be used to determine the feasibility, sample size and power calculations for a large multicentre study.Ethics and disseminationThe study has been approved by South Eastern Sydney Local Health District Human Research Ethics Committee (HREC/15/331/POHW/586).Trial registration numberNCT03240783; Pre-results.
Project description:BackgroundNonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to treat sciatica, despite insufficient evidence from placebo-controlled trials. NSAIDs may cause serious side effects; hence, there is a strong need to clarify their potential beneficial effects in patients with sciatica.MethodsThis is a multicentre, randomized, placebo-controlled, parallel-group superiority trial. Participants will be recruited among sciatica patients referred to outpatient clinics at hospitals in Norway who have radiating pain below the knee with a severity score of ≥ 4 on a 0-10 numeric rating scale and clinical signs of nerve root or spinal nerve involvement. The intervention consists of oral naproxen 500 mg or placebo twice daily for 10 days. Participants will report the outcomes and adverse events daily using an electronic case report form. The primary endpoint is change in leg pain intensity from baseline to day 10 based on daily observations. The secondary outcomes are back pain intensity, disability, sciatica symptom severity, rescue medication (paracetamol) consumption, opioid use, ability to work or study, 30% and 50% improvement in leg pain, and global perceived change of sciatica/back problem. The outcomes will be analysed using mixed effects models for repeated measurements. The total duration of follow-up is 12 (± 2) days.DiscussionThis trial aims to evaluate the benefits of naproxen, a non-selective NSAID, in patients with sciatica. No important differences in efficacy have been demonstrated between different NSAIDs in the management of musculoskeletal disorders; hence, the results of this trial will likely be applicable to other NSAIDs.Trial registrationClinicalTrials.gov NCT03347929 . Registered on November 20, 2017.
Project description:Sciatica or the sciatic syndrome is a common and often disabling low back disorder in the working-age population. It has a relatively high heritability but poorly understood molecular mechanisms. The Finnish population is a genetic isolate where small founder population and bottleneck events have led to enrichment of certain rare and low frequency variants. We performed here the first genome-wide association (GWAS) and meta-analysis of sciatica. The meta-analysis was conducted across two GWAS covering 291 Finnish sciatica cases and 3671 controls genotyped and imputed at 7.7 million autosomal variants. The most promising loci (p<1x10-6) were replicated in 776 Finnish sciatica patients and 18,489 controls. We identified five intragenic variants, with relatively low frequencies, at two novel loci associated with sciatica at genome-wide significance. These included chr9:14344410:I (rs71321981) at 9p22.3 (NFIB gene; p = 1.30x10-8, MAF = 0.08) and four variants at 15q21.2: rs145901849, rs80035109, rs190200374 and rs117458827 (MYO5A; p = 1.34x10-8, MAF = 0.06; p = 2.32x10-8, MAF = 0.07; p = 3.85x10-8, MAF = 0.06; p = 4.78x10-8, MAF = 0.07, respectively). The most significant association in the meta-analysis, a single base insertion rs71321981 within the regulatory region of the transcription factor NFIB, replicated in an independent Finnish population sample (p = 0.04). Despite identifying 15q21.2 as a promising locus, we were not able to replicate it. It was differentiated; the lead variants within 15q21.2 were more frequent in Finland (6-7%) than in other European populations (1-2%). Imputation accuracies of the three significantly associated variants (chr9:14344410:I, rs190200374, and rs80035109) were validated by genotyping. In summary, our results suggest a novel locus, 9p22.3 (NFIB), which may be involved in susceptibility to sciatica. In addition, another locus, 15q21.2, emerged as a promising one, but failed to replicate.
Project description:ObjectiveFull-endoscopic spine surgery is gaining interest as a less-invasive alternative to treat sciatica caused by a lumbar disc herniation. Concerns, however, exist with the learning curve as percutaneous transforaminal endoscopic discectomy (PTED) appears to be more difficult to be performed compared to other techniques. In this study, the clinical outcomes during and after the learning curve are presented of 3 surgeons naïve to PTED.MethodsIn the first phase of a randomized controlled, noninferiority trial comparing PTED with microdiscectomy, 3 surgeons were trained in the PTED-procedure by a senior surgeon. After performing up to 20 cases under supervision, they started performing PTED on their own. Results of the early cases were compared to the later cases (>20). Furthermore, complications and reoperations were compared. Finally, differences in clinical outcomes between surgeons were compared.ResultsAt 12 months of follow-up, 87% of the patients had follow-up data available. In general, there were no significant differences in patient-reported outcomes between the early and later PTED cases. Furthermore, outcomes of the early PTED cases were comparable to the outcomes of microdiscectomy, while the later PTED cases had small, but more favorable outcomes compared to microdiscectomy. Two learning curve surgeons had substantially higher rates of reoperations within 1 year, compared to the senior surgeon or the microdiscectomy group. Duration of surgery was also longer for all learning curve surgeons. Finally, when comparing clinical outcomes of patients undergoing PTED versus microdiscectomy, there appears to be some statistically significant differences in outcomes compared between the senior and 3 learning curve surgeons.ConclusionPTED appears to be safe to be adopted by surgeons naïve to the procedure when they are initially supervised by an experienced senior surgeon. Duration of surgery and risk of repeated surgery are increased during the learning curve, but patient-reported outcomes of the early PTED cases are similar to the outcomes of later PTED cases, and similar to the outcomes of microdiscectomy cases. This study underlines the need for an experienced mentor for surgeons to safely adopt PTED.
Project description:BackgroundThis systematic review focusses on inflammation as an underlying pathogenic mechanism in sciatica. We addressed two questions in particular: (1) what inflammatory biomarkers have been identified in patients with sciatica in the literature so far? 2) is there an association between the level of inflammatory activity and clinical symptoms?MethodsThe search was conducted up to December 19th 2018 in MEDLINE, EMBASE, CENTRAL and Web of Science. The study selection criteria: (1) observational cohort studies, cross-sectional studies and randomized clinical trials (RCT), (2) adult population (≥ 18 years) population with sciatica, (3) concentrations of inflammatory biomarkers measured in serum, cerebrospinal fluid (CSF) or biopsies, and (4) evaluation of clinically relevant outcome measures (pain or functional status). Three reviewers independently selected studies and extracted data regarding the study characteristics and the outcomes. Risk of Bias was evaluated using an adjusted version of the Quality in Prognosis Studies (QUIPS) tool.ResultsIn total 16 articles fulfilled the criteria for inclusion: 7 cross sectional observational studies and 9 prospective cohort studies that included a total of 1212 patients. With regard to question 1) the following markers were identified: interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-17, IL-21, tumor necrosis factor-α (TNF-α), phospholipase A2, high sensitivity C-reactive protein (hsCRP), C-X-C motif chemokine 5 (CXCM5), CX3CL1, CCL2, epidermal growth factor (EGF), and monocyte chemotactic protein 4 (MCP-4). With regard to question 2) several positive correlations were found in longitudinal studies: a strong positive correlation between inflammatory mediators or byproducts and pain (measured by visual analogue scale, VAS) was found for IL-21 in two studies (r > 0,8), and moderate positive correlations for TNF-a in both serum (r = 0,629) and biopsy (r = 0.65); severe pain (VAS > 4) is associated with increased hsCRP levels among patients with sciatica (adjusted OR = 3.4 (95% CI, 1.1 to 10).ConclusionIn this systematic review there was considerable heterogeneity in the type of biomarkers and in the clinical measurements in the included studies. Taking into account the overall risk of bias of the included studies there is insufficient evidence to draw firm conclusions regarding the relationship between inflammation and clinical symptoms in patients with sciatica.
Project description:ObjectivePercutaneous transforaminal endoscopic discectomy (PTED) is gaining popularity by both surgeons and patients as a less invasive treatment option for sciatica. Concerns, however, exist for its learning curve. No previous study has assessed the learning process of PTED. Hereby we present the learning process of 3 surgeons learning PTED.MethodsThis analysis was conducted alongside a multicenter randomized controlled trial. After attending a cadaveric workshop, 3 spine-dedicated surgeons started performing PTED, initially under the supervision of a senior surgeon. After each 5 cases, and up to case 20, the learning process was evaluated using the validated questionnaires (objective structured assessment of technical skills [OSATS], global operative assessment of laparoscopic skills [GOALS]) and a 10-step checklist specifically developed for PTED.ResultsIn total, 3 learning curve surgeons performed a total of 161 cases. Based on self-assessment, surgeons improved mostly in the domains "time and motion," "respect for tissue," and "knowledge and handling of instruments." Learning curve surgeons were more able to detect differences in performances on the OSATS than the senior surgeon. Based on the GOALS, the biggest improvements could be seen in "depth-perception" and "autonomy." Based on the 10-item specific checklist, all surgeons performed all 10 steps by case 10, while only 1 surgeon performed all steps adequately by case 15.ConclusionBased on these study results, PTED appears to be successfully adopted stepwise by 3 spine-dedicated surgeons. From 15 cases on, most steps are performed adequately. However, more cases might be necessary to achieve good clinical results. Validated tools are needed to determine the cutoff when a surgeon should be able to perform PTED independently.