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T. Kaufmann, A. Trout, D. Kallmes (2006)
The effects of cement volume on clinical outcomes of percutaneous vertebroplasty.AJNR. American journal of neuroradiology, 27 9
A. Trout, D. Kallmes, L. Gray, Barbara Goodnature, Sandra Everson, B. Comstock, J. Jarvik (2005)
Evaluation of vertebroplasty with a validated outcome measure: the Roland-Morris Disability Questionnaire.AJNR. American journal of neuroradiology, 26 10
D. Kallmes, B. Comstock, P. Heagerty, J. Turner, David Wilson, T. Diamond, R. Edwards, L. Gray, Lydia Stout, S. Owen, W. Hollingworth, Basavaraj Ghdoke, D. Annesley-Williams, S. Ralston, J. Jarvik (2009)
A randomized trial of vertebroplasty for osteoporotic spinal fractures.The New England journal of medicine, 361 6
J. Farrar, James Young, L. Lamoreaux, J. Werth, R. Poole (2001)
Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scalePAIN, 94
M. Buonocore, A. Aloisi, M. Barbieri, A. Gatti, C. Bonezzi (2009)
Vertebral body innervation: Implications for painJournal of Cellular Physiology, 222
D. Patrick, R. Deyo, S. Atlas, D. Singer, Alice Chapin, R. Keller (1995)
Assessing Health‐Related Quality of Life in Patients With SciaticaSpine, 20
M. Roland, J. Fairbank (2000)
The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire.Spine, 25 24
R. Buchbinder, R. Osborne, P. Ebeling, J. Wark, P. Mitchell, Chris Wriedt, S. Graves, M. Staples, Bridie Murphy (2009)
A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures.The New England journal of medicine, 361 6
L. Gray, J. Jarvik, P. Heagerty, W. Hollingworth, Lydia Stout, B. Comstock, J. Turner, D. Kallmes (2007)
INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplastyBMC Musculoskeletal Disorders, 8
A. Amar, D. Larsen, Nasrin Esnaashari, F. Albuquerque, S. Lavine, G. Teitelbaum (2001)
Percutaneous Transpedicular Polymethylmethacrylate Vertebroplasty for the Treatment of Spinal Compression FracturesNeurosurgery, 49
R. Orr (2010)
Vertebroplasty, cognitive dissonance, and evidence-based medicine: What do we do when the ‘evidence’ says we are wrong?Cleveland Clinic Journal of Medicine, 77
J. Barr, M. Barr, T. Lemley, R. McCann (2000)
Percutaneous Vertebroplasty for Pain Relief and Spinal StabilizationSpine, 25
R. Dworkin, D. Turk, KathleenW. Wyrwich, D. Beaton, C. Cleeland, J. Farrar, J. Haythornthwaite, M. Jensen, R. Kerns, D. Ader, N. Brandenburg, L. Burke, D. Cella, J. Chandler, P. Cowan, R. Dimitrova, R. Dionne, S. Hertz, A. Jadad, Nathaniel Katz, H. Kehlet, Lynn Kramer, D. Manning, Cynthia McCormick, M. Mcdermott, H. McQuay, S. Patel, L. Porter, S. Quessy, B. Rappaport, C. Rauschkolb, D. Revicki, M. Rothman, K. Schmader, B. Stacey, Joseph Stauffer, T. Stein, Richard White, J. Witter, S. Zavisic (2008)
Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.The journal of pain : official journal of the American Pain Society, 9 2
R. Ostelo, R. Deyo, P. Stratford, G. Waddell, P. Croft, M. Korff, L. Bouter, H. Vet (2008)
Interpreting Change Scores for Pain and Functional Status in Low Back Pain: Towards International Consensus Regarding Minimal Important ChangeSpine, 33
J. Hodler, D. Peck, L. Gilula (2003)
Midterm outcome after vertebroplasty: predictive value of technical and patient-related factors.Radiology, 227 3
M. Bolster (2010)
Consternation and questions about two vertebroplasty trialsCleveland Clinic Journal of Medicine, 77
BACKGROUND AND PURPOSE: INVEST is a recently published double-blind placebo controlled randomized trial that demonstrated similar improvements in pain between blinded vertebroplasty and sham-vertebroplasty groups. LABEL is a trial determining the efficacy of pain relief of an injection of lidocaine and bupivacaine at the site of painful osteoporotic vertebral compression fractures in unblinded patients. We compared outcomes from the unblinded LABEL trial with those of blinded control patients from the lead site of the INVEST, exploring the role of blinding on the benefit of local anesthesia infusion for painful vertebral compression fractures. MATERIALS AND METHODS: Nineteen patients with painful osteoporotic vertebral compression fractures underwent unblinded injection of lidocaine and bupivacaine at the site of painful osteoporotic vertebral compression fractures. Patients were given the option of undergoing vertebroplasty at any time following the procedure. Primary outcome measures were change in the RDQ and pain (at rest, with activity, and average 24-hour pain) at days 1 and 3 following the injection. Day 3 change in RDQ scores and change in average 24-hour pain were compared for LABEL and INVEST control patients from the lead site ( n = 16). RESULTS: Among patients in the LABEL trial, we detected no significant improvement in RDQ scores, pain at rest, and average 24-hour pain at days 1 and 3, whereas pain with activity improved significantly at both time points. INVEST control patients from the lead site experienced significantly greater improvement in average pain during 24 hours at days 1 ( P = .03) and 3 ( P = .04) and significantly greater improvements in RDQ scores at day 3 ( P = .006) than patients from LABEL. CONCLUSIONS: An unblinded injection of local anesthesia is ineffective in treating pain from osteoporotic compression fractures. This suggests that factors other than local anesthesia were responsible for the observed improvement in the control group in INVEST. Abbreviations INVEST Investigational Vertebroplasty Efficacy and Safety Trial LABEL Local Anesthesia with Bupivacaine and Lidocaine for Vertebral Fracture RCT randomized controlled trial RDG Roland-Morris Disability Questionnaire
American Journal of Neuroradiology – American Journal of Neuroradiology
Published: Oct 1, 2010
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