Abstract
Purpose: The Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), a randomized blinded controlled study of Vertebroplasty, demonstrated similar improvements in pain between blinded Vertebroplasty and sham-Vertebroplasty groups. The result from the RCT study suggested that the observed efficacy of the Vertebroplasty procedure, instead of representing the cement-mediated reduction in pain, may relate to the vertebral bone drilling per se. The aim of this study was to demonstrate the effectiveness of pain relief of vertebral bone drilling at the site of painful osteoporotic vertebral compression fractures in the acute phase. Materials and Methods: Twenty-six patients with painful osteoporotic compression fractures underwent the vertebral bone drilling. We assessed primary outcome measures in the NRS pain score and RDQ score at day 0 and 3 following the drilling. Comparisons were made by using Wilcoxon signed rank test. Results: The mean baseline NRS and RDQ score, and the mean NRS and RDQ score at day 3 were 7.3 ± 1.2, 15.7 ± 4.2, 4.6 ± 1.4, 7.3 ± 2.2, respectively. Among the patients, we detected significant improvements in NRS pain score and RDQ score at day 3 following the drilling compared with day 0 (P al compression fractures alleviated the intractable pain due to osteoporotic vertebral compression fractures.
Highlights
Vertebroplasty was first described in 1987 [1]. It became a general treatment for symptomatic vertebral compression fractures
Two independent placebo-controlled Randomized Controlled Trials B.D (RCTs) studies [4,5] found Vertebroplasty to be equivalent to a sham intervention
Study Participants Consecutive patients presenting to the pain clinic for painful vertebral compression fractures were screened for enrollment between December 2009 and November 2010
Summary
Vertebroplasty was first described in 1987 [1]. It became a general treatment for symptomatic vertebral compression fractures. Vertos II [2] and FREE trial [3], which compared Vertebroplasty or Kyphoplasty to traditional conventional management, show the efficacy of Vertebroplasty for painful vertebral compression fractures. Two independent placebo-controlled RCT studies [4,5] found Vertebroplasty to be equivalent to a sham intervention. The sham procedure simulated the Vertebroplasty without injection of cement. The two groups were a similar reduction in pain, and improve-
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