You are here

  • Home
  • Archive
  • Volume 8, Issue 7
  • Does early intervention improve outcomes in the physiotherapy management of lumbar radicular syndrome? Results of the POLAR pilot randomised controlled trial

Article Text

Article menu

Download PDFPDF

XML
Rehabilitation medicine
Research
Does early intervention improve outcomes in the physiotherapy management of lumbar radicular syndrome? Results of the POLAR pilot randomised controlled trial
  1. Michael Reddington1,
  2. Stephen J Walters2,
  3. Judith Cohen3,
  4. Susan K Baxter4,
  5. Ashley Cole5
  1. 1 Therapy Services Outpatient Department, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital, Sheffield, UK
  2. 2 Medical Statistics Group, ScHARR, University of Sheffield, Sheffield, UK
  3. 3 Hull Health Trials Unit, Hull York Medical School, University of Hull, Hull, UK
  4. 4 Section of Public Health, ScHARR, University of Sheffield, Sheffield, UK
  5. 5 Orthopaedic Department, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital, Sheffield, UK
  1. Correspondence to Michael Reddington; mreddington1{at}sheffield.ac.uk

Abstract

Objective To investigate the feasibility of undertaking a definitive randomised controlled trial (RCT).

Setting This was a pilot, pragmatic superiority RCT with a qualitative element, recruiting from 14 general practitioner (GP) practices in England.

Participants Patients over 18 years of age presenting to their GP with unilateral lumbar radicular syndrome (LRS), defined as radicular pain and/or neurological symptoms originating from lumbar nerve roots, were eligible to participate in the study, those who did not have a clear understanding of the English language or had comorbidities preventing rehabilitation were ineligible.

Interventions Participants were randomised into early intervention physiotherapy or usual care with the former receiving their treatment within 2 weeks after randomisation and the latter 6 weeks postrandomisation. Both groups received a patient-centred, goal-orientated physiotherapy programme specific to their needs. Participants received up to six treatment sessions over an 8-week period.

Outcome measures Process outcomes to determine the feasibility of the study and an exploratory analysis of patient-reported outcomes, including self-rated disability, pain and general health, these were collected at baseline, 6, 12 and 26 weeks postrandomisation.

Results 80 participants were recruited in 10 GP practices over 34 weeks and randomised to (early intervention physiotherapy n=42, usual care n=38). Follow-up rates at 26 weeks were 32 (84%) in the usual care and 36 (86%) in the early intervention physiotherapy group. The mean area under the curve (larger values indicating more disability) for the Oswestry Disability Index over the 26 weeks was 16.6 (SD 11.4) in the usual care group and 16.0 (SD 14.0) in the intervention group. A difference of −0.6 (95% CI −0.68 to 5.6) in favour of the intervention group.

Conclusions The results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with LRS.

Trial registration number NCT02618278, ISRCTN25018352.

  • back pain
  • musculoskeletal disorders
  • spine

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2018-021631

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors MR instigated the idea for the study, developed the funding proposal and applied for funding. He developed the protocol, intervention handbook, gained ethical approval and acted as CI for the study. SJW is the primary supervisor for MRs' fellowship and contributed to the study conception, design and writing of the protocol and provided guidance with the statistical analysis. JC is an academic supervisor for MR and has provided specific guidance on protocol development, regulatory approvals and the design of the study. SKB provided input regarding the qualitative and mixed-method design and analysis aspects of the study. AC provided clinical supervision for MR. He has been involved in the conception of the study, its organisation, analysis and writing. All authors read and commented on drafts, and approved the final version of the manuscript.

    • Funding The lead author (MR) has received a personal Clinical Doctoral Research Fellowship (CDRF) award from Health Education England (HEE) and the National Institute of Health Research (NIHR). Award number: CDRF-2014-05-046.

    • Disclaimer This paper presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval Ethical approval was received from NHS Scotland, East of Scotland Research Ethics Service (EoSRES) in August 2015 (REC reference 15/ES/0130). The study was conducted in accordance with the declaration of Helsinki and local governance requirements.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement There are no additional data available for the study which has not been published. All data are available to anyone interested by contacting the corresponding author.