title: Efficacy and cost-effectiveness of intradiscal methylene blue injection for chronic discogenic low back pain: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Low back pain (LBP) is a common health problem and a substantial part of LBP is presumed to be attributable to degeneration of the intervertebral disc. For patients suffering from intractable discogenic LBP, there are few evidence-based effective interventional treatment options available. In 2010, the results of a randomized controlled trial (RCT) were published concerning "intradiscal methylene blue injection" (IMBI), in which this intervention appeared to be very successful in relieving discogenic pain. Therefore, we decided to repeat this study to investigate whether we could replicate the published results. The results of our preliminary feasibility study gave reason to set up an RCT. The aim of this RCT is to evaluate if IMBI is a more effective treatment of discogenic low back pain as an intradiscal placebo intervention, and furthermore, to assess the cost-effectiveness of this intervention.
  
  
  METHODS
  Consecutive discogenic low back pain patients referred to four specialized pain treatment facilities are being screened for eligibility. After a positive standardized provocation discography and informed consent, patients are randomized into two groups. The treatment group receives an intradiscal injection with methylene blue, lidocaine, and contrast, and the control group receives intradiscal isotonic saline with lidocaine and contrast. Main outcome measures are pain at the 6-month follow-up, patient's global impression of change, cost-effectiveness, quality of life, disability, and analgesic intake.
  
  
  CONCLUSIONS
  The importance of this study is emphasized by the fact that for intractable discogenic low back pain patients, evidence-based effective pain treatments are rare. If this study establishes clinical success and cost-effectiveness, IMBI could become the "pain treatment of choice" for a selected group of patients with chronic discogenic low back pain for whom noninvasive treatment options have failed.
  
  
  BACKGROUND
  National Trial register NTR2547 Registered at 29 September 2010 and 31 March 2014.
authors.affiliation: Department of Anaesthesiology, and Pain Medicine, Maastricht University Medical Centre, Mailbox 5800, 6202, AZ, Maastricht, The Netherlands. Jose.geurts@mumc.nl.
authors.forename: José W
authors.initials: JW
authors.lastname: Geurts
authors.affiliation: Rijnstate Hospital, Department of Anaesthesiology and Pain Management, Mailbox 9555, 6800, TA, Arnhem, The Netherlands. jkallewaard@rijnstate.nl.
authors.forename: Jan-Willem
authors.initials: JW
authors.lastname: Kallewaard
authors.affiliation: Department of Clinical Epidemiology and Medical Technology, Maastricht University Medical Centre, P. Debeijlaan 25, 6229, HX, Maastricht, The Netherlands. fons.kessels@maastrichtuniversity.nl.
authors.forename: Alfons
authors.initials: A
authors.lastname: Kessels
authors.affiliation: Department of Orthopaedic Surgery, Maastricht University Medical Centre, Mailbox 5800, 6202, AZ, Maastricht, The Netherlands. p.willems@mumc.nl.
authors.forename: Paul C
authors.initials: PC
authors.lastname: Willems
authors.affiliation: Department of Neurosurgery, Maastricht University Medical Centre, Mailbox 5800, 6202, AZ, Maastricht, The Netherlands. h.van.santbrink@mumc.nl.|'Department of Neurosurgery, Atrium Medisch Centrum Heerlen', Heerlen, The Netherlands. h.van.santbrink@mumc.nl.
authors.forename: Henk
authors.initials: H
authors.lastname: van Santbrink
authors.affiliation: Department of Clinical Epidemiology and Medical Technology, Maastricht University Medical Centre, P. Debeijlaan 25, 6229, HX, Maastricht, The Netherlands. c.dirksen@mumc.nl.
authors.forename: Carmen
authors.initials: C
authors.lastname: Dirksen
authors.affiliation: Department of Anaesthesiology, and Pain Medicine, Maastricht University Medical Centre, Mailbox 5800, 6202, AZ, Maastricht, The Netherlands. maarten.van.kleef@mumc.nl.
authors.forename: Maarten
authors.initials: M
authors.lastname: van Kleef
mesh_terms: D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics*; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000191:economics; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000503:physiopathology; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D004311:Double-Blind Method; D004338:Drug Combinations; D016527:Drug Costs; D006801:Humans; D015552:Injections, Intralesional; D007403:Intervertebral Disc / Q000187:drug effects* / Q000503:physiopathology; D055959:Intervertebral Disc Degeneration / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000503:physiopathology; D008012:Lidocaine / Q000008:administration & dosage / Q000191:economics; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000503:physiopathology; D008751:Methylene Blue / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics*; D009426:Netherlands; D010147:Pain Measurement; D017060:Patient Satisfaction; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000779:Anesthetics, Local; D004338:Drug Combinations; D008012:Lidocaine; D008751:Methylene Blue