title: Intraarticular Facet Injections for Low Back Pain: Design Considerations, Consensus Methodology to Develop the Protocol for a Randomized Controlled Trial.
abstract: BACKGROUND
  Since the publication of guidelines by the UK National Institute for Health and Care Excellence (NICE) and the American Pain Society guidelines for low back pain in 2009 there have been deep divisions in the pain treatment community about the use of therapeutic intraarticular facet joint injections. While evidence for the effectiveness or not of intraarticular facet joint injections remains sparse, uncertainty will remain. The Warwick feasibility study, along with a concurrent study with a different design led by another group, aims to provide a stable platform from which the effectiveness and cost effectiveness of intraarticular facet joint injections added to normal care could be evaluated in randomized controlled trials (RCTs).
  
  
  OBJECTIVE
  To reach consensus on key design considerations for the Warwick facet feasibility study from which the study protocol and working manuals will be developed.
  
  
  METHODS
  A consensus conference involving expert professionals and lay members.
  
  
  METHODS
  Preliminary work identified 5 key design considerations for deliberation at our consensus conference. Three concerned patient assessment and treatment: diagnosis of possible facet joint pain, interaarticular facet joint injection technique, and best usual care. Two concerned trial analysis: a priori sub-groups and minimally important difference and are reported elsewhere. We did systematic evidence reviews of the design considerations and summarized the evidence. Our design questions and evidence summaries were distributed to all delegates. This formed the basis for discussions on the day. Clinical experts in all aspects of facet joint injection from across the UK along with lay people were invited via relevant organizations. Nominal group technique was used in 15 facilitated initial small group discussions. Further discussion and ranking was undertaken in plenary. All small group and plenary results were recorded and checked and verified post conference. Where necessary participants were contacted via email to resolve outstanding issues.
  
  
  RESULTS
  Fifty-two delegates attended the conference with lay people and all relevant professions represented. Consensus was reached on the details of how to assess patients for facet joint pain, undertake the injections, and deliver usual care. Where post conference checking of results revealed errors in calculating ranking results on the day, consensus was reached by email consultation. All but 3 delegates agreed to be associated with the outcome.
  
  
  CONCLUSIONS
  Allocating one day for discussing a wide range of topics imposed time pressure on discussion and calculation of the numerous rankings.
  
  
  CONCLUSIONS
  Through the use of an evidence-based, systematic, inclusive, and transparent process we have established consensus from expert health professionals in the UK, with lay input, on the clinical assessment of suspected facet joint pain, interaarticular injection for facet joint pain, and best usual care for use in a feasibility study for a proposed pragmatic clinical trial of interaarticular facet joint injections. This provides a strong basis for a clinical trial that will be acceptable to the pain treatment community.
authors.affiliation: Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK;
authors.forename: Tom
authors.initials: T
authors.lastname: Mars
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK;
authors.forename: David R
authors.initials: DR
authors.lastname: Ellard
authors.affiliation: Anaesthesia & Pain Medicine, South Warwickshire NHS Foundation Trust, Warwick Hospital, Lakin Road, Warwick, CV34 5BW, UK.
authors.forename: James H L
authors.initials: JH
authors.lastname: Antrobus
authors.affiliation: Department of Allied Health Professions and Midwifery, School of Health and Social Work.
authors.forename: Melinda
authors.initials: M
authors.lastname: Cairns
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK;
authors.forename: Martin
authors.initials: M
authors.lastname: Underwood
authors.affiliation: RCN Research Institute, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry CV4 7AL, UK.
authors.forename: Kirstie
authors.initials: K
authors.lastname: Haywood
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, UK;
authors.forename: Susie
authors.initials: S
authors.lastname: Keohane
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, CV4 7AL, 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;
authors.forename: Frances
authors.initials: F
authors.lastname: Griffiths
mesh_terms: D000779:Anesthetics, Local / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use; D002045:Bupivacaine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D002985:Clinical Protocols; D032921:Consensus; D003695:Delivery of Health Care / Q000379:methods; D019317:Evidence-Based Medicine; D005081:Exercise Therapy; D005240:Feasibility Studies; D006801:Humans; D007270:Injections, Intra-Articular; D000077554:Levobupivacaine; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000534:rehabilitation; D010147:Pain Measurement; D010353:Patient Education as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D014221:Triamcinolone / Q000008:administration & dosage / Q000627:therapeutic use; D021801:Zygapophyseal Joint
chemical_list: D000779:Anesthetics, Local; D000893:Anti-Inflammatory Agents; D014221:Triamcinolone; D000077554:Levobupivacaine; D002045:Bupivacaine