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      Are the presence of MODIC changes on MRI scans related to “improvement” in low back pain patients treated with lumbar facet joint injections?

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          Abstract

          Background

          Modic changes (MC) have been linked with low back pain (LBP) and worse outcomes from some treatments. No studies have investigated the impact that MCs may have on patient outcomes from lumbar facet injections. Therefore, the purpose of this study is to investigate whether the presence of Modic changes is related to ‘improvement’ in patients undergoing imaging-guided lumbar facet injection therapy.

          Methods

          Outcomes from 226 patients with MRI scans within 3 months of their imaging-guided lumbar facet injections were investigated to determine whether MCs are related to ‘improvement’ post injection. At 1 day, 1 week and 1 month post injection the Patients Global Impression of Change scale answers were collected by postal questionnaire. This was the primary outcome measure. The numerical rating scale for pain data was collected prior to treatment and at the same post injection time points. The MRI scans were independently evaluated by two examiners for the presence/absence of Modic changes and the type of Modic change if present. Kappa statistics were used for reliability of diagnosis analysis. Chi-squared test and logistic regression analysis tested MCs with ‘improvement’.

          Results

          Intra- and inter-examiner reliability for the diagnosis of MCs was Kappa = 0.77 and 0.74. Intra- and inter-examiner reliability for categorizing MCs was K = 0.77 and K = 0.78.

          At 1 month post injection 45.2 % of patients without MCs reported clinically relevant ‘improvement’ compared to 34.2 % of patients with MC I and 32.1 % of patients with MC II. However, this did not reach statistical significance. Logistic regression found that Modic changes were not predictive of ‘improvement’.

          Conclusions

          There was a tendency for patients without MCs to have better outcomes but this did not reach statistical significance. The reliability of diagnosing MCs was substantial.

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          Most cited references 27

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          The measurement of observer agreement for categorical data.

           G Koch,  J R Landis (1977)
          This paper presents a general statistical methodology for the analysis of multivariate categorical data arising from observer reliability studies. The procedure essentially involves the construction of functions of the observed proportions which are directed at the extent to which the observers agree among themselves and the construction of test statistics for hypotheses involving these functions. Tests for interobserver bias are presented in terms of first-order marginal homogeneity and measures of interobserver agreement are developed as generalized kappa-type statistics. These procedures are illustrated with a clinical diagnosis example from the epidemiological literature.
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            A Coefficient of Agreement for Nominal Scales

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              Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.

              Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.
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                Author and article information

                Contributors
                matilde.bianchi@chirosuisse.ch
                41 (0)44 386 5712 , cynthia.peterson@balgrist.ch
                christian.pfirrmann@balgrist.ch
                juerg.hodler@usz.ch
                jbolton@aecc.ac.uk
                Journal
                BMC Musculoskelet Disord
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central (London )
                1471-2474
                4 September 2015
                4 September 2015
                2015
                : 16
                Affiliations
                [ ]Private Practice & Chiropractic Medicine Department, Orthopaedic University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008 Zürich, Switzerland
                [ ]Departments of Radiology and Chiropractic Medicine, Orthopaedic University Hospital Balgrist, University of Zürich, Forchstrasse 340, 8008 Zürich, Switzerland
                [ ]Department of Radiology, Orthopaedic University Hospital of Balgrist, University of Zürich, Forchstrasse 340, 8008 Zürich, Switzerland
                [ ]Department of Radiology, University Hospital, University of Zürich, Rämistrasse 100, 8091 Zürich, Switzerland
                [ ]Research and Continuing Professional Development, Anglo-European College of Chiropractic, 13-15 Parkwood Road, Bournemouth, BH5 2DF UK
                688
                10.1186/s12891-015-0688-x
                4558765
                © Bianchi et al. 2015

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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                Orthopedics

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