title: Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial.
abstract: BACKGROUND
  The role of injections of therapeutic substances into the back as treatment for low back pain is unclear. Facet joint injections are widely used despite the absence of evidence of sustained benefit. We hypothesise that facet joint injections might facilitate engagement with physiotherapist-led, best usual care (a combined physical and psychological programme) and is a clinically and cost-effective treatment for people with suspected low back pain of facet joint origin.
  
  
  METHODS
  We present here the protocol for a randomised controlled feasibility trial for a main trial to test the above hypotheses. Patients referred to secondary care with persistent non-specific low back pain will be screened and invited to take part in the study. Those who meet the eligibility criteria will be invited for a physiotherapy assessment to confirm trial eligibility and for baseline data collection. All participants (n = 150) will be offered the best usual care package with physical and psychological components. Those randomised into the intervention arm (n = 75) will, in addition, receive intra-articular facet joint injections with local anaesthetic and steroids. Primary outcome data will be collected using daily and then weekly text messaging service for a pain score on a 0-10 scale. Questionnaire follow-up will be at 3, 6, and 12 months. Evaluation of trial processes and health economic analyses, including a value of information analysis, will be undertaken. The process evaluation will be mixed methods and will include the views of all stakeholders.
  
  
  CONCLUSIONS
  Whilst this trial is a feasibility study it is currently one of the largest trials in this area. The outcomes will provide some evidence on the use of facet joint injections for patients with clinically diagnosed facet joint pain.
  
  
  BACKGROUND
  EudraCT identifier 2014-000682-50, (registered on 12 February 14). ISRCTN registry number: ISRCTN93184143 DOI 10.1186/ISRCTN93184143 (registered on 27 February 2014).
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. Harbinder.K.Sandhu@warwick.ac.uk.
authors.forename: Harbinder
authors.initials: H
authors.lastname: Sandhu
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. d.r.ellard@warwick.ac.uk.
authors.forename: David R
authors.initials: DR
authors.lastname: Ellard
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. F.Achana@warwick.ac.uk.
authors.forename: Felix
authors.initials: F
authors.lastname: Achana
authors.affiliation: Anaesthesia & Pain Medicine, South Warwickshire NHS Foundation Trust, Warwick Hospital, Lakin Road, Warwick, CV34 5BW, UK. Hugh.Antrobus@swft.nhs.uk.
authors.forename: James H L
authors.initials: JH
authors.lastname: Antrobus
authors.affiliation: Anaesthesia & Pain Services, University Hospital Coventry and Warwickshire, Clifford Bridge Road, Coventry, CV2 2DX, UK. shyam.balasubramanian2@uhcw.nhs.uk.
authors.forename: Shyam
authors.initials: S
authors.lastname: Balasubramanian
authors.affiliation: UNTRAP, The University of Warwick, Coventry, CV4 7AL, UK. sallybee52@talktalk.net.
authors.forename: Sally
authors.initials: S
authors.lastname: Brown
authors.affiliation: Department of Allied Health Professions and Midwifery, School of Health and Social Work, University of Hertfordshire, Hatfield, Hertfordshire, AL10 9AB, UK. m.cairns@herts.ac.uk.
authors.forename: Melinda
authors.initials: M
authors.lastname: Cairns
authors.affiliation: Social Science and Systems in Health, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. F.E.Griffiths@warwick.ac.uk.
authors.forename: Frances
authors.initials: F
authors.lastname: Griffiths
authors.affiliation: RCN Research Institute, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. K.L.Haywood@warwick.ac.uk.
authors.forename: Kirstie
authors.initials: K
authors.lastname: Haywood
authors.affiliation: Population Evidence and Technologies Room, Warwick Medical School, The University of Warwick, University Hospitals of Coventry and Warwickshire, Clifford Bridge Road, Coventry, CV2 2DX, UK. C.E.Hutchinson@warwick.ac.
authors.forename: Charles
authors.initials: C
authors.lastname: Hutchinson
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. R.Lall@warwick.ac.uk.
authors.forename: Ranjit
authors.initials: R
authors.lastname: Lall
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. S.Petrou@warwick.ac.uk.
authors.forename: Stavros
authors.initials: S
authors.lastname: Petrou
authors.affiliation: Statistics and Epidemiology, Division of Health Sciences, The University of Warwick, Coventry, CV4 7AL, UK. N.Stallard@warwick.ac.uk.
authors.forename: Nigel
authors.initials: N
authors.lastname: Stallard
authors.affiliation: UNTRAP, The University of Warwick, Coventry, CV4 7AL, UK. colintysall@hotmail.com.
authors.forename: Colin
authors.initials: C
authors.lastname: Tysall
authors.affiliation: Arthritis Research UK Pain Centre, Academic Rheumatology, University of Nottingham, NG51PB, Nottingham, UK. david.walsh@nottingham.ac.uk.
authors.forename: David A
authors.initials: DA
authors.lastname: Walsh
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK. M.Underwood@warwick.ac.uk.
authors.forename: Martin
authors.initials: M
authors.lastname: Underwood
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D005240:Feasibility Studies; D006801:Humans; D007270:Injections, Intra-Articular; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D021801:Zygapophyseal Joint / Q000187:drug effects* / Q000503:physiopathology
chemical_list: D000305:Adrenal Cortex Hormones; D000700:Analgesics; D000779:Anesthetics, Local