title: A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures.
abstract: BACKGROUND
  Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.
  
  
  METHODS
  We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (< 6 weeks or > or = 6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.
  
  
  RESULTS
  A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (+/-SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6+/-2.9 and 1.9+/-3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.
  
  
  CONCLUSIONS
  We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)
authors: Monash Department of Clinical Epidemiology, Cabrini Hospital, and Monash University, Malvern, VIC, Australia. rachelle.buchbinder@med.monash.edu.au
authors: Rachelle
authors: R
authors: Buchbinder
authors: Richard H
authors: RH
authors: Osborne
authors: Peter R
authors: PR
authors: Ebeling
authors: John D
authors: JD
authors: Wark
authors: Peter
authors: P
authors: Mitchell
authors: Chris
authors: C
authors: Wriedt
authors: Stephen
authors: S
authors: Graves
authors: Margaret P
authors: MP
authors: Staples
authors: Bridie
authors: B
authors: Murphy
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D001416:Back Pain / Q000209:etiology / Q000628:therapy; D001843:Bone Cements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007278:Injections, Spinal; D008297:Male; D010024:Osteoporosis / Q000150:complications*; D010147:Pain Measurement; D015990:Placebo Effect; D011109:Polymethacrylic Acids; D011788:Quality of Life; D016103:Spinal Fractures / Q000209:etiology / Q000628:therapy*; D017211:Treatment Failure; D054854:Vertebroplasty / Q000379:methods
chemical_list: D001843:Bone Cements; D011109:Polymethacrylic Acids; C030613:polymethacrylic acid