OASIS—a randomised, placebo-controlled trial of oral glucocorticoids for leg pain in patients with acute sciatica: trial protocol

IntroductionSciatica is a lower spine condition characterised by radiating leg pain below the knee. It may be accompanied by motor and sensory loss in the distribution of a spinal nerve. There are few effective treatments for sciatica. Orally administered glucocorticoids have shown some promise, however, any beneficial effects need to be confirmed and weighed against drug safety and cost-effectiveness, in a high-quality, definitive trial.Methods and analysisThe Oral Steroids In Sciatica (OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica. Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments and randomised to receive orally administered prednisolone 50 mg per day, up to 3 days then tapering to cessation over 10 days, or placebo, for a maximum of 13 days, in addition to guideline advice. Participants will be followed for 1 year. The primary endpoint will be leg pain intensity at 2 weeks. Secondary outcomes will include back pain intensity, disability, time to recovery, quality of life and treatment success rate. Adverse events will be assessed and a cost-effectiveness analysis will be conducted.Ethics and disseminationEthical approval has been granted from the Human Research Ethics Committee, The University of Sydney. Trial results will be disseminated by publications and conference presentations and via the media.Trial registration numberACTRN12619001716156.

Short-term Efficiency and Tolerance of Ketoprofen and Methylprednisolone in Acute Sciatica: A Randomized Trial

Objective Although anti-inflammatory drugs are commonly used in acute discogenic sciatica, data regarding their efficacy are scarce and controversial. We compared the efficacy and safety of intravenous ketoprofen and methylprednisolone with placebo in sciatica. Design Multicenter, double-blinded randomized controlled trial. Subjects Patients with confirmed discogenic acute sciatica, without neurologic deficit, were randomized into three arms. Methods Besides standard-of-care analgesic therapy, they received intravenous injections of methylprednisolone (60 mg/d) or ketoprofen (200 mg/d) or placebo for five days. The primary outcome was leg pain over five days. Secondary outcomes were clinical responses at days 3 and 5, lumbar pain, Straight Leg Raise Test and lumbar flexion index, analgesic consumption, realization of lumbar spine injections, and surgery during the study period. Results Fifty-four patients were randomized, and 50 completed the study. In patients admitted to the hospital for pain control with acute lumbar radicular pain due to intervertebral disc herniation and receiving an oral analgesic protocol including paracetamol, nefopam, tramadol, and morphine, there was no additional analgesic effect seen between groups. There was no significant difference in leg pain between the three groups over the study period. In the methylprednisolone group, however, we observed a higher rate of clinically relevant responses at day 3. No difference was observed on other secondary efficacy outcomes and safety. Conclusion No significant difference in leg pain was observed between groups. However, there was a higher proportion of patients relieved with intravenous methylprednisolone at day 3, compared with ketoprofen or placebo.

COMMONLY UTILIZED PHYSIOTHERAPY TREATMENT APPROACHES IN THE MANAGEMENT OF SUB-ACUTE SCIATICA: A DELPHI STUDY

There is limited evidence for the utilization of physiotherapy in the management of sub-acute sciatica. The aim of this study is to reach consensus on physiotherapeutic approaches to the management of sub-acute sciatica amongst a panel of clinicians experienced in this field. The Delphi method was chosen as the process. The panel comprised expert physiotherapists ([Formula: see text]) working within a musculoskeletal outpatient setting within the United Kingdom National Health Service. Iteration 1 consisted of the open-ended question ‘List the treatment approaches/techniques/modalities you employ when treating a patient with sub-acute sciatica and provide justifications’. Themes reaching 70% consensus progressed to the second iteration which followed up with the question “Please indicate how frequently you would employ the following treatments in the management of sub-acute sciatica” using a 5-point likert scale ranging from 1 (never) to 5 (always). The mean score was calculated for each treatment and those themes achieving a mean of 3.5 or greater progressed to iteration 3 “Please rank in order of preference which of the following treatments you would employ in the treatment of sub-acute sciatica”. The response rate at iteration 3 was 100%. This study achieved consensus on two treatment approaches to be employed in the management of sub-acute sciatica. These treatments were advice on the nature and natural history of the condition and self-help activities such as heat/ice, staying active and rest when needed.

Protocol of the randomised placebo controlled pilot trial of the management of acute sciatica (SCIATICA): a feasibility study

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.