title: A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV).
abstract: BACKGROUND
  The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.
  
  
  METHODS
  The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.
  
  
  CONCLUSIONS
  The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.
  
  
  BACKGROUND
  This study is registered at ClinicalTrials.gov., NCT01200277.
authors.affiliation: Department of Radiology, St, Elisabeth Ziekenhuis, Hilvarenbeekseweg 60, Tilburg, The Netherlands. crisfiranescu@hotmail.com
authors.forename: Cristina
authors.initials: C
authors.lastname: Firanescu
authors.forename: Paul Nm
authors.initials: PN
authors.lastname: Lohle
authors.forename: Jolanda
authors.initials: J
authors.lastname: de Vries
authors.forename: Caroline A
authors.initials: CA
authors.lastname: Klazen
authors.forename: Job R
authors.initials: JR
authors.lastname: Juttmann
authors.forename: William
authors.initials: W
authors.lastname: Clark
authors.forename: Willem Jan
authors.initials: WJ
authors.lastname: van Rooij
mesh_terms: D000208:Acute Disease; D000700:Analgesics / Q000627:therapeutic use; D001416:Back Pain / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D004185:Disability Evaluation; D050815:Fractures, Compression / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D009426:Netherlands; D010024:Osteoporosis / Q000150:complications* / Q000175:diagnosis; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D016103:Spinal Fractures / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D016896:Treatment Outcome; D054854:Vertebroplasty
chemical_list: D000700:Analgesics