Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

Abstract

BackgroundLow-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory.MethodsAdults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study.DiscussionThis prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement.

Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica

“…The pilot built on previous research in this participant group undertaken by team members, 20,21,30,39 which had already provided information on trial administration, the characteristics of sciatica participants and the effects of biological treatments from previous studies. The internal pilot was designed to rehearse the procedures and logistics to be undertaken in the main trial.…”

“…39 The ATLAS study recruited 609 patients from 17 general medical practices (approximate total adult population of 90,200) over 24 months. Analysis of the recruitment data shows that 219 (36%) participants in this cohort had sciatica with pain in one leg only (with > 80% diagnostic confidence,) with a RMDQ score of > 7 points (equivalent to an ODI score of ≥ 30 points).…”

“…39 However, we made unrealistic assumptions about the numbers of identified participants who would be willing to participate in a clinical trial of an investigational medicinal product. Although we identified large numbers of potential participants, only small numbers returned reply slips indicating a willingness to participate.…”

Reliability among clinicians diagnosing low back-related leg pain

“…Details of the ATLAS study protocol are reported elsewhere [16]. In brief, patients visiting their General Practitioner (GP) with LBLP were invited to attend a research clinic where they underwent a clinical assessment by a physiotherapist.…”

“…As part of the ATLAS study they attended training sessions related to the procedures of the study. Details of the training are reported elsewhere [16]. Raters for part two were six health professionals involved in managing LBLP patients.…”