Title: Physiotherapy Management of Lumbar Radicular Syndrome; Does early Intervention Improve Outcomes?
Funder: Health Education England

Abstract: This pilot trial is an essential preliminary to a definitive RCT assessing the effectiveness and cost-effectiveness of an early physiotherapy intervention. The pilot will ensure the design and methods of the future trial are sound, practicable and feasible. The pilot study will be a scaled down version of the future RCT, and will run for 48 months with 80 patients being recruited with Lumbar Radicular Syndrome (LRS) from primary care. The patients will be randomised to usual care or early physiotherapy. All participants will then be followed up for 6 months. A nested qualitative study will explore patients' experiences of LRS. Background Lumbar Radicular Syndrome (LRS) is perhaps better known as sciatica. It can be a very painful and debilitating condition, having a great effect on both the individual sufferer and society at large. The individual effects can include severe pain and disability, which may only last a few weeks but can be lifelong. Patients suffering with LRS also complain about the effect on their ability to work and take part in normal day to day activities, such as sport or looking after their children. The optimum management strategies for LRS are elusive. Surgery is an option with stated success in the majority of patients but it is expensive and not without significant risk. Physiotherapy is another option but the type, duration and timing remain unproven.Aims The primary aim of the pilot study is to determine the feasibility of carrying out a future, full scale Randomised Controlled Trial (RCT). The second aim of the study is to determine the patient views and experiences of LRS, its effects on their lives and the physiotherapy management they have experienced.Plan of investigation The design is a mixed methods design consisting of 2 parts. Firstly an external pilot Randomised Controlled Trial (RCT) will investigate the effects of physiotherapy for (LRS) at 2 different time points. 80 patients will be recruited from one of two primary care physiotherapy providers. They will be randomised, after consent into early intervention physiotherapy at 2 weeks after consultation with their G.P or usual care physiotherapy at 6 weeks. Both groups will receive the same physiotherapy 'package' based on a framework devised by the researcher and colleagues. This will be delivered by 1 of 4 physiotherapists who will have undergone training in delivery of the intervention. Secondly and to run concurrently with the RCT will be a qualitative component which will consist of patient interviews which will investigate the effects of LRS on the individuals quality of life and their perceptions of physiotherapy and the timing of physiotherapy management for LRS. Potential impact The pilot study will provide information as to the feasibility of perfoming a full-scale RCT with economic analysis for early intervention physiotherapy for patients with LRS. The impact of the study will be to guide the future study; the recruitment parameters, the use of outcome measures, the ability to deliver the intervention at the appropriate time-point with acceptable fidelity, and the acceptance of the intervention by patients and clinicians alike. The study will also provide information as to patients experiences of LRS. The information gained will be useful in directing future research as well as helping to improve patient care. The use of the physiotherapy framework will be tested as to its ease of use by clinicians and its acceptance, in primary care by patients.

Lay abstract: This study aims to determine the feasibility of performing a full-scale trial of early intervention physiotherapy for people with sciatica. Sciatica is often caused by a nerve being compressed in the lower back and is likely to heal itself with time. Patients will be asked to take part in the study and randomised into early physiotherapy or usual timing physiotherapy. They will also be interviewed to obtain their insights into how sciatica affects them and their experiences of physiotherapy for sciatica. The study results will determine whether it is feasible to carry out a full-scale study in the near future.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL;NEUROLOGICAL