title: Cost-effectiveness of minimal interventional procedures for chronic mechanical low back pain: design of four randomised controlled trials with an economic evaluation.
abstract: BACKGROUND
  Minimal interventional procedures are frequently applied in patients with mechanical low back pain which is defined as pain presumably resulting from single sources: facet, disc, sacroiliac joint or a combination of these. Usually, these minimal interventional procedures are an integral part of a multidisciplinary pain programme. A recent systematic review issued by the Dutch Health Insurance Council showed that the effectiveness of these procedures for the total group of patients with chronic low back pain is yet unclear and cost-effectiveness unknown. The aim of the study is to evaluate whether a multidisciplinary pain programme with minimal interventional procedures is cost-effective compared to the multidisciplinary pain programme alone for patients with chronic mechanical low back pain who did not respond to conservative primary care and were referred to a pain clinic.
  
  
  METHODS
  All patients with chronic low back pain who are referred to one of the 13 participating pain clinics will be asked to participate in an observational study. Patients with a suspected diagnosis of facet, disc or sacroiliac joint problems will receive a diagnostic block to confirm this diagnosis. If confirmed, they will be asked to participate in a randomized controlled trial (RCT). For each single source a separate RCT will be conducted. Patients with a combination of facet, disc or sacroiliac joint problems will be invited for participation in a RCT as well. An economic evaluation from a societal perspective will be performed alongside these four RCTs. Patients will complete questionnaires at baseline, 3 and 6 weeks, 3, 6, 9 and 12 months after start of the treatment. Costs will be collected using self-completed cost questionnaires.
  
  
  CONCLUSIONS
  No trials are yet available which have evaluated the cost-effectiveness of minimal interventional procedures in patients with chronic mechanical low back pain, which emphasizes the importance of this study.
  
  
  BACKGROUND
  National Trial Register: NTR3531.
authors.affiliation: Department of Health Sciences and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands. esther.maas@vu.nl
authors.forename: Esther T
authors.initials: ET
authors.lastname: Maas
authors.forename: Johan N S
authors.initials: JN
authors.lastname: Juch
authors.forename: J George
authors.initials: JG
authors.lastname: Groeneweg
authors.forename: Raymond W J G
authors.initials: RW
authors.lastname: Ostelo
authors.forename: Bart W
authors.initials: BW
authors.lastname: Koes
authors.forename: Arianne P
authors.initials: AP
authors.lastname: Verhagen
authors.forename: Merel
authors.initials: M
authors.lastname: van Raamt
authors.forename: Frank
authors.initials: F
authors.lastname: Wille
authors.forename: Frank J P M
authors.initials: FJ
authors.lastname: Huygen
authors.forename: Maurits W
authors.initials: MW
authors.lastname: van Tulder
mesh_terms: D059350:Chronic Pain / Q000175:diagnosis / Q000191:economics* / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000191:economics* / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D019060:Minimally Invasive Surgical Procedures / Q000191:economics*; D018803:Models, Economic; D009426:Netherlands; D010147:Pain Measurement; D017060:Patient Satisfaction; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome