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<meta name="HW.identifier" content="/ajnr/30/6/1203.atom" />
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<meta name="DC.Title" content="Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial" />
<meta name="DC.Identifier" content="10.3174/ajnr.A1519" />
<meta name="DC.Date" content="2009-06-01" />
<meta name="DC.Publisher" content="American Journal of Neuroradiology" />
<meta name="DC.Rights" content="Copyright © American Society of Neuroradiology." />
<meta name="DC.AccessRights" content="open-access" />
<meta name="DC.Description" content="BACKGROUND AND PURPOSE: Multiple case series of vertebroplasty outcomes have been published, though no large, placebo controlled trial has yet been performed. Our aim was to report baseline characteristics for the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), a randomized blinded controlled study of vertebroplasty.

MATERIALS AND METHODS: We compared baseline demographics, pain scores, and scores on the modified Roland-Morris Disability Scale (RMDS), a back pain−specific metric, between 2 groups. One group included subjects enrolled at the lead INVEST site ( n = 27 to date). The second group consisted of eligible patients seen concurrently at the lead INVEST site, who declined enrollment ( n = 70). Comparisons were made by using 2-sample t tests.

RESULTS: Mean ages were similar between groups, averaging approximately 74 years among study participants and 77 years among nonenrolled eligible patients ( P = .17). Approximately 75% of subjects were female in both groups. RMDS scores of enrolled patients at the lead site (18.0 ± 4.2) were not statistically different from those of eligible nonenrolled patients at the lead site (18.6 ± 3.6, P = .49). Pain scores in the enrolled subjects were measured as “average intensity over the prior 24 hours” with mean scores of 7.6 ± 2.1 among enrolled patients at the lead site. Pain scores in eligible nonenrolled patients were measured as “pain at rest,” with mean score of 3.4 ± 3.3, and “pain with activity,” with mean score of 8.5 ± 2.0.

CONCLUSIONS: Patient demographics among subjects enrolled in the INVEST are similar to those in a cohort of eligible nonenrolled patients. Back pain−specific disability was similar between subjects enrolled in the INVEST study and eligible nonenrolled patients at the lead site." />
<meta name="DC.Contributor" content="D.F. Kallmes" />
<meta name="DC.Contributor" content="B.A. Comstock" />
<meta name="DC.Contributor" content="L.A. Gray" />
<meta name="DC.Contributor" content="P.J. Heagerty" />
<meta name="DC.Contributor" content="W. Hollingworth" />
<meta name="DC.Contributor" content="J.A. Turner" />
<meta name="DC.Contributor" content="L. Stout" />
<meta name="DC.Contributor" content="J.G. Jarvik" />
<meta name="article:published_time" content="2009-06-01" />
<meta name="article:section" content="SPINE" />
<meta name="citation_title" content="Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial" />
<meta name="citation_abstract" lang="en" content="&lt;p&gt;&lt;b&gt;BACKGROUND AND PURPOSE:&lt;/b&gt; Multiple case series of vertebroplasty outcomes have been published, though no large, placebo controlled trial has yet been performed. Our aim was to report baseline characteristics for the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), a randomized blinded controlled study of vertebroplasty.&lt;/p&gt;&lt;p&gt;&lt;b&gt;MATERIALS AND METHODS:&lt;/b&gt; We compared baseline demographics, pain scores, and scores on the modified Roland-Morris Disability Scale (RMDS), a back pain−specific metric, between 2 groups. One group included subjects enrolled at the lead INVEST site (&lt;i&gt;n&lt;/i&gt; = 27 to date). The second group consisted of eligible patients seen concurrently at the lead INVEST site, who declined enrollment (&lt;i&gt;n&lt;/i&gt; = 70). Comparisons were made by using 2-sample &lt;i&gt;t&lt;/i&gt; tests.&lt;/p&gt;&lt;p&gt;&lt;b&gt;RESULTS:&lt;/b&gt; Mean ages were similar between groups, averaging approximately 74 years among study participants and 77 years among nonenrolled eligible patients (&lt;i&gt;P&lt;/i&gt; = .17). Approximately 75% of subjects were female in both groups. RMDS scores of enrolled patients at the lead site (18.0 ± 4.2) were not statistically different from those of eligible nonenrolled patients at the lead site (18.6 ± 3.6, &lt;i&gt;P&lt;/i&gt; = .49). Pain scores in the enrolled subjects were measured as “average intensity over the prior 24 hours” with mean scores of 7.6 ± 2.1 among enrolled patients at the lead site. Pain scores in eligible nonenrolled patients were measured as “pain at rest,” with mean score of 3.4 ± 3.3, and “pain with activity,” with mean score of 8.5 ± 2.0.&lt;/p&gt;&lt;p&gt;&lt;b&gt;CONCLUSIONS:&lt;/b&gt; Patient demographics among subjects enrolled in the INVEST are similar to those in a cohort of eligible nonenrolled patients. Back pain−specific disability was similar between subjects enrolled in the INVEST study and eligible nonenrolled patients at the lead site.&lt;/p&gt;" />
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<meta name="citation_issn" content="0195-6108" />
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<meta name="citation_reference" content="citation_title=American Journal of Neuroradiology;citation_journal_abbrev=Am. J. Neuroradiol.;citation_title=Vertebroplasty, First 1000 Levels of a Single Center: Evaluation of the Outcomes and Complications;citation_pages=683-689;citation_volume=28;citation_year=2007;citation_issue=4;citation_issn=0195-6108;citation_pmid=17416821" />
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<meta name="twitter:title" content="Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial" />
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<meta name="twitter:description" content="BACKGROUND AND PURPOSE: Multiple case series of vertebroplasty outcomes have been published, though no large, placebo controlled trial has yet been performed. Our aim was to report baseline characteristics for the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), a randomized blinded controlled study of vertebroplasty.

MATERIALS AND METHODS: We compared baseline demographics, pain scores, and scores on the modified Roland-Morris Disability Scale (RMDS), a back pain−specific metric, between 2 groups. One group included subjects enrolled at the lead INVEST site ( n = 27 to date). The second group consisted of eligible patients seen concurrently at the lead INVEST site, who declined enrollment ( n = 70). Comparisons were made by using 2-sample t tests.

RESULTS: Mean ages were similar between groups, averaging approximately 74 years among study participants and 77 years among nonenrolled eligible patients ( P = .17). Approximately 75% of subjects were female in both groups. RMDS scores of enrolled patients at the lead site (18.0 ± 4.2) were not statistically different from those of eligible nonenrolled patients at the lead site (18.6 ± 3.6, P = .49). Pain scores in the enrolled subjects were measured as “average intensity over the prior 24 hours” with mean scores of 7.6 ± 2.1 among enrolled patients at the lead site. Pain scores in eligible nonenrolled patients were measured as “pain at rest,” with mean score of 3.4 ± 3.3, and “pain with activity,” with mean score of 8.5 ± 2.0.

CONCLUSIONS: Patient demographics among subjects enrolled in the INVEST are similar to those in a cohort of eligible nonenrolled patients. Back pain−specific disability was similar between subjects enrolled in the INVEST study and eligible nonenrolled patients at the lead site." />
<meta name="og-title" property="og:title" content="Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial" />
<meta name="og-url" property="og:url" content="http://ajnr-stage2.stage.highwire.org/content/30/6/1203" />
<meta name="og-site-name" property="og:site_name" content="American Journal of Neuroradiology" />
<meta name="og-description" property="og:description" content="BACKGROUND AND PURPOSE: Multiple case series of vertebroplasty outcomes have been published, though no large, placebo controlled trial has yet been performed. Our aim was to report baseline characteristics for the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), a randomized blinded controlled study of vertebroplasty.

MATERIALS AND METHODS: We compared baseline demographics, pain scores, and scores on the modified Roland-Morris Disability Scale (RMDS), a back pain−specific metric, between 2 groups. One group included subjects enrolled at the lead INVEST site ( n = 27 to date). The second group consisted of eligible patients seen concurrently at the lead INVEST site, who declined enrollment ( n = 70). Comparisons were made by using 2-sample t tests.

RESULTS: Mean ages were similar between groups, averaging approximately 74 years among study participants and 77 years among nonenrolled eligible patients ( P = .17). Approximately 75% of subjects were female in both groups. RMDS scores of enrolled patients at the lead site (18.0 ± 4.2) were not statistically different from those of eligible nonenrolled patients at the lead site (18.6 ± 3.6, P = .49). Pain scores in the enrolled subjects were measured as “average intensity over the prior 24 hours” with mean scores of 7.6 ± 2.1 among enrolled patients at the lead site. Pain scores in eligible nonenrolled patients were measured as “pain at rest,” with mean score of 3.4 ± 3.3, and “pain with activity,” with mean score of 8.5 ± 2.0.

CONCLUSIONS: Patient demographics among subjects enrolled in the INVEST are similar to those in a cohort of eligible nonenrolled patients. Back pain−specific disability was similar between subjects enrolled in the INVEST study and eligible nonenrolled patients at the lead site." />
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        	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-volume highwire-cite-metadata">Vol. 30</span>, <span  class="highwire-cite-metadata-issue highwire-cite-metadata">Issue 6 </span><div  class="highwire-cite-metadata-pubdate highwire-cite-metadata">June 2009 </div></div>
      
      
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      <div class="highwire-cite-title">Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial</div>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0"><span class="nlm-given-names">D.F.</span> <span class="nlm-surname">Kallmes</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">B.A.</span> <span class="nlm-surname">Comstock</span></span>, <span class="highwire-citation-author" data-delta="2"><span class="nlm-given-names">L.A.</span> <span class="nlm-surname">Gray</span></span>, <span class="highwire-citation-author" data-delta="3"><span class="nlm-given-names">P.J.</span> <span class="nlm-surname">Heagerty</span></span>, <span class="highwire-citation-author" data-delta="4"><span class="nlm-given-names">W.</span> <span class="nlm-surname">Hollingworth</span></span>, <span class="highwire-citation-author" data-delta="5"><span class="nlm-given-names">J.A.</span> <span class="nlm-surname">Turner</span></span>, <span class="highwire-citation-author" data-delta="6"><span class="nlm-given-names">L.</span> <span class="nlm-surname">Stout</span></span>, <span class="highwire-citation-author" data-delta="7"><span class="nlm-given-names">J.G.</span> <span class="nlm-surname">Jarvik</span></span></span></div>
  
    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-oa-ind highwire-cite-metadata"><i class="highwire-oa-indicator"></i> </span><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">Jun 2009, </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">30 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(6) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1203-1205; </span><span  class="highwire-cite-metadata-doi highwire-cite-metadata"><span class="label">DOI:</span> 10.3174/ajnr.A1519 </span></div>
  
  
  
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      <div class="highwire-cite-title">Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial</div>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0"><span class="nlm-given-names">D.F.</span> <span class="nlm-surname">Kallmes</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">B.A.</span> <span class="nlm-surname">Comstock</span></span>, <span class="highwire-citation-author" data-delta="2"><span class="nlm-given-names">L.A.</span> <span class="nlm-surname">Gray</span></span>, <span class="highwire-citation-author" data-delta="3"><span class="nlm-given-names">P.J.</span> <span class="nlm-surname">Heagerty</span></span>, <span class="highwire-citation-author" data-delta="4"><span class="nlm-given-names">W.</span> <span class="nlm-surname">Hollingworth</span></span>, <span class="highwire-citation-author" data-delta="5"><span class="nlm-given-names">J.A.</span> <span class="nlm-surname">Turner</span></span>, <span class="highwire-citation-author" data-delta="6"><span class="nlm-given-names">L.</span> <span class="nlm-surname">Stout</span></span>, <span class="highwire-citation-author" data-delta="7"><span class="nlm-given-names">J.G.</span> <span class="nlm-surname">Jarvik</span></span></span></div>
  
    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-oa-ind highwire-cite-metadata"><i class="highwire-oa-indicator"></i> </span><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">Jun 2009, </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">30 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(6) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1203-1205; </span><span  class="highwire-cite-metadata-doi highwire-cite-metadata"><span class="label">DOI:</span> 10.3174/ajnr.A1519 </span></div>
  
  
  
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