title: Efficacy, Safety, and Predictors of Intradiscal Methylene Blue Injection for Discogenic Low Back Pain: Results of a Multicenter Prospective Clinical Series.
abstract: METHODS
  Prospective clinical study of intradiscal methylene blue injection for the treatment of lumbar discogenic pain.
  
  
  OBJECTIVE
  The objective of this study was to collect information about efficacy, safety, and acceptability of the intervention, gain and burden of outcome measures, and sample size assumptions for a potential following randomized controlled trial (RCT). If the pilot study demonstrates that this treatment is potentially effective and safe, and the methods and procedures used in this study are feasible, a RCT follows.
  
  
  BACKGROUND
  Low back pain (LBP) is a highly common problem with a lifetime prevalence of more than 70%. A substantial part of chronic LBP is attributable to degenerative changes in the intervertebral disc. A recently published RCT assessing the treatment intradiscal injection of methylene blue for chronic discogenic LBP, showed exceptionally good results.
  
  
  METHODS
  Patients were selected on clinical criteria, magnetic resonance imaging, and a positive provocative discogram. The primary outcome measure was mean pain reduction at 6 months.
  
  
  RESULTS
  Fifteen consecutive patients with chronic lumbar discogenic pain enrolled in a multicenter prospective case series in two interventional pain treatment centers in the Netherlands. Six months after the intervention, 40% of the patients claimed at least 30% pain relief. In patients who responded, physical function improved and medication use diminished. We observed no procedural complications or adverse events. Predictors for success were Pfirrmann grading of 2 or less and higher quality of life mental component scores.
  
  
  CONCLUSIONS
  Our findings of 40% positive respondents, and no complications, give reason to set up a randomized, double-blind, placebo-controlled, trial.
authors.affiliation: Department of Anaesthesiology and Pain Management, Rijnstate Hospital, Arnhem, the Netherlands.
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: Kallewaard
authors.affiliation: Department of Anaesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: José W
authors.initials: JW
authors.lastname: Geurts
authors.affiliation: Department of Clinical Epidemiology and Medical Technology, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Alphons
authors.initials: A
authors.lastname: Kessels
authors.affiliation: Department of Orthopaedic Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Paul
authors.initials: P
authors.lastname: Willems
authors.affiliation: Department of Neurosurgery, Maastricht University Medical Centre, Maastricht, the Netherlands.|Department of Neurosurgery, Atrium Medisch Centrum Heerlen, Heerlen, the Netherlands.
authors.forename: Henk
authors.initials: H
authors.lastname: van Santbrink
authors.affiliation: Department of Anaesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: van Kleef
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007403:Intervertebral Disc; D007405:Intervertebral Disc Displacement / Q000150:complications / Q000188:drug therapy*; D017116:Low Back Pain / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008751:Methylene Blue / Q000008:administration & dosage*; D008875:Middle Aged; D009426:Netherlands; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D008751:Methylene Blue
keywords: chronic pain; intervertebral disc; low back pain; methylene blue; refractory pain