Title: Stratified Care for Patients with Sciatica and Suspected Sciatica in Primary Care: A randomised trial (the SCOPiC trial - SCiatica Outcomes in Primary Care)
Funder: Department of Health and Social Care

Abstract: Design: Pragmatic randomised controlled trial, with linked qualitative interviews. Setting: Primary care, with a ‘fast-track’ pathway to secondary care. Target Population: All adults presenting in primary care with sciatica or suspected sciatica, irrespective of duration of symptoms. Inclusions: 18 years and over, primary care consulters with sciatica or suspected sciatica, have a mobile phone or access to a land-line telephone, able to give full, informed consent. Exclusions: Suspected serious spinal pathology, previous lumbar spine surgery, ongoing care from or consultation with secondary care doctor or physiotherapist for same problem in the last 3 months, serious co-morbidity, pregnancy, unable to communicate in English. Patient identification is via 2 methods: i) electronic ‘pop-up’ prompts within GP computer software fired by appropriate Read codes, ii) regular retrospective GP record reviews. Invitation letters and information will be posted to all potentially eligible patients, inviting them to telephone a community sciatica clinic administrator for brief eligibility screening and clinic appointment. At clinic, patients will have a standardised assessment for sciatica or suspected sciatica by trained study physiotherapists and further screened for eligibility. Leg pain due to causes other than sciatica or suspected sciatica will be excluded. Those eligible and willing to participate will provide written consent and baseline data will be collected, including data on prognosis and clinical indicators. Research nurses will undertake 1:1, telephone-based, third-party, telephone-based, randomisation (provided by the CTU) and inform participants of their allocated treatment. Individual patients will be randomised, stratified by treatment site and risk subgroup, using random permuted blocks of varying size, to either stratified care or usual, non-stratified care. Health technology being assessed: The health technology being assessed is stratified care for primary care consulters with sciatica. Stratified care combines subgrouping patients, using clear criteria, into one of three subgroups each of which receives one of three matched treatments. The criteria combine 4 key clinical indicators (interference with ability to do work (including work around the house), pain below the knee, intense leg pain, loss of or reduced pin prick sensation) that predict referral to secondary care and 8 key prognostic indicators (using the validated STarT Back tool). Using a stratification algorithm (see figure 2), patients randomised to the intervention arm will be stratified into one of three subgroups (low risk, medium risk, high risk): •Patients at low risk: brief treatment package, in up to 2 treatment visits, comprising advice, reassurance, information and education to support self-management and analgesia. •Patients at medium risk: a course of evidence-based, physiotherapist-led treatment, including patient education, individualised exercise and manual therapy. The package will include efforts to optimise pain medication, support for return to work and continuation of everyday activities. •Patients at high risk: a fast-track pathway to spinal specialists for assessment for suitability for more invasive treatments, including spinal injections or surgery. 'Fast-track’ is defined as immediate referral to spinal specialist assessment with that spinal specialist assessment occurring within 4 weeks from the community sciatica clinic visit. An MRI scan will be part of the pathway for patients in this subgroup. Control intervention: Usual, non-stratified care. This will be recorded using case report forms at the clinic, patient self-report questionnaires and medical record reviews collecting data on healthcare received. Measurement of Outcomes: Primary outcome is time to patient-reported resolution of symptoms (either ‘completely recovered’ or ‘much better’), collected using regular SMS text messages (with the option of brief phone calls instead). These will occur weekly for the first 16 weeks or until patient reports complete resolution, then monthly from months 4 to 12 (or until the patient reports complete resolution). Secondary outcomes at 4 and 12 months include pain, function, self-rated global perceived recovery, self-efficacy, fear of movement, anxiety and depression, risk of poor outcome, quality of life, work and productivity loss, healthcare utilisation, pain medication, adverse events and patient satisfaction. Follow-up and minimum data collection will be overseen by blinded research nurses. Process data (proportions of patients appropriately referred and treated relative to their risk subgroup) will determine the impact of stratified care on service delivery. In addition, the cost-effectiveness of stratified care compared with usual, non-stratified care will be evaluated from NHS and societal perspectives. Sample size: The sample size is 470 patients in total, in order to compare stratified care to usual, non-stratified care, for time to resolution of symptoms. This sample size will allow us to detect a hazard ratio of at least 1.4 in mean survival times (time to resolution of symptoms) with power of 90%, two-tailed statistical significance of 5%, 1:1 allocation and 20% loss to follow-up. In order to recruit 470 patients to the trial, we will need approximately 29 GP practices, and two centres providing community sciatica clinics. We estimate 3,264 potentially eligible patients to be invited to a community sciatica clinic, 1,958 (60%) to attend the clinic for detailed screening for eligibility, 1,175 (60%) to have sciatica or suspected sciatica at the community clinic and 40% of these to consent to participate in the trial (n=470). Analysis plan: Primary analysis will compare time to self-reported resolution between stratified care and usual, non-stratified care, on an intention-to-treat basis. A Kaplan-Meier survival analysis will estimate the time from randomisation until resolution of symptoms. Cox regression analysis will compare time to recovery between groups by calculation of a hazard ratio. Secondary analysis at 4 and 12 months, and a small number of pre-specified subgroup analyses will be conducted. Cost-effectiveness will be estimated from an NHS as well as a societal perspective. A linked qualitative interview study will determine the acceptability of the fast-track pathway to patients and clinicians. Full detail is given in the 20 page protocol.

Lay abstract: Sciatica and "suspected sciatica" describe patients who have back-related leg pain or other leg symptoms such as pins and needles or muscle weakness, most likely due to compression or irritation of spinal nerve roots (the place where the spinal nerves branch off from the spinal cord). Sciatica has a significant impact on patients; pain can lead to problems with everyday activities, including time off work, and even unemployment, leading to financial burdens for families as well as health and social services. Whilst many patients have mild problems, a substantial proportion (estimated at up to 30%) suffer with pain for a year or more and incurs considerable costs. Sciatica and suspected sciatica are common problems in primary care, where the majority of patients are managed. Over 60% of patients consulting their general practitioner (GP) with back pain also report associated leg pain, and whilst not all of these are thought to have sciatica, 38% report leg pain below the knee, one of several criteria that clinicians use to help decide if the problem is sciatica. Patients with leg pain have worse outcomes than those with back pain only and those with pain below the knee have the worst outcomes of all. In primary care, our research shows that up to 70% of patients with back-related leg pain are considered to have sciatica or suspected sciatica. The most common causes for sciatic pain are a prolapsed disc which presses on the spinal nerves, and narrowing of the spaces within the spinal canal or where the spinal nerves leave the spinal column (spinal stenosis). However, estimates of how common sciatica is do vary widely (from 1.2% to 43%) depending on the definition of sciatica, the setting, the population studied and the method of assessment of patients. Therefore, many patients with back-related leg pain in primary care have suspected sciatica rather than true sciatica. In current practice, patients with sciatica and suspected sciatica tend to be managed in primary care with a 'wait-and-see' approach, with some patients eventually being referred to other professionals such as physiotherapists for help with pain and function or to spinal specialists including pain specialists and orthopaedic surgeons. There is no UK National Institute of Health and Clinical Excellence (NICE) guidance about the best way to treat sciatica patients and little previous research specifically on this patient population. Current treatments range widely from information and advice, medications, exercise and manual therapy, to more invasive treatments such as spinal injections and surgery. A particular problem for patients with sciatica and suspected sciatica is the current delay in treatment. The wide variation in the management of patients throughout the UK means that some patients are offered unnecessary treatments whilst others are denied access to effective treatments. Patients with sciatica and suspected sciatica are a more complex group for GPs than those with non-specific low back pain. In particular, GPs are concerned about missing important pathology and spinal specialists worry that those patients who would benefit from 'fast-tracking' for consideration for secondary care treatments such as spinal injections and surgery are not well identified or referred in a timely fashion. The recently published NHS Spinal Taskforce (January 2013) made some recommendations based largely on the opinion of experts rather than research evidence, highlighting the urgent need for good quality trial evidence about treatments for sciatica. Given that the responsibility for early treatment decisions for patients with sciatica is in primary care, a large high quality trial in this setting is particularly needed. Our trial seeks to improve primary care management of patients with sciatica and suspected sciatica through a new approach called stratified care. Stratified care is a model of care with two components; i) clearer identification and subgrouping of patients with different characteristics and ii) matching of patient subgroups to different treatments. It includes early identification of patients who are most likely to benefit from referral to spinal specialists. Our stratified care approach combines systematic information about individual patients' likelihood of recovery (prognostic information) with information from their clinical history and physical examination (clinical indicators of the severity of sciatica) in order to ensure that the right patient gets the right treatment at the right time. Using a systematic step-by-step procedure that combines information about each patient's likelihood of a poor outcome and the presence of important clinical indicators, patients with sciatica and suspected sciatica who consult in primary care will be grouped into one of three subgroups (referred to as low, medium and high risk) and matched to appropriate and timely treatments. Patients will be grouped into those likely to get better who can be given good advice and self-help support in up to 2 treatment visits (low risk, estimated to be 12%), those with more troublesome problems who should be referred for a course of physiotherapy treatments (medium risk, estimated to be 57%); and those with more significantly troublesome problems who need fast-tracked to early spinal specialist assessment and treatment (high risk, estimated 31%). Over 4 years, we will conduct a large randomised trial with 470 patients who consult in primary care with sciatica and suspected sciatica, and include linked interviews with patients and clinicians. We will test whether stratified care leads to faster recovery for patients than usual, non-stratified care, whether it leads to better outcomes at 4 and 12 months follow-up, whether it is acceptable to patients and clinicians, whether it changes the proportions of patients who access appropriate treatments for their profile, and whether it is cost-effective for the NHS to adopt more widely. Given the particular problem of sciatica in leading to time off work, we will also test whether stratified care leads to savings for society. We believe that stratified care for patients with sciatica and suspected sciatica in primary care has real potential to improve patients' experiences and outcomes, and increase the efficiency of primary care in a major way, but a large high quality trial is needed to test this out.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL