Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy.
ABSTRACT PURPOSE: Modic type 1 changes/bone edema in the vertebrae are present in 6 % of the general population and 35-40 % of the low back pain population. It is strongly associated with low back pain. The aim was to test the efficacy of antibiotic treatment in patients with chronic low back pain (>6 months) and Modic type 1 changes (bone edema). METHODS: The study was a double-blind RCT with 162 patients whose only known illness was chronic LBP of greater than 6 months duration occurring after a previous disc herniation and who also had bone edema demonstrated as Modic type 1 changes in the vertebrae adjacent to the previous herniation. Patients were randomized to either 100 days of antibiotic treatment (Bioclavid) or placebo and were blindly evaluated at baseline, end of treatment and at 1-year follow-up. OUTCOME MEASURES: Primary outcome, disease-specific disability, lumbar pain. Secondary outcome leg pain, number of hours with pain last 4 weeks, global perceived health, EQ-5D thermometer, days with sick leave, bothersomeness, constant pain, magnetic resonance image (MRI). RESULTS: 144 of the 162 original patients were evaluated at 1-year follow-up. The two groups were similar at baseline. The antibiotic group improved highly statistically significantly on all outcome measures and improvement continued from 100 days follow-up until 1-year follow-up. At baseline, 100 days follow-up, 1-year follow-up the disease-specific disability-RMDQ changed: antibiotic 15, 11, 5.7; placebo 15, 14, 14. Leg pain: antibiotics 5.3, 3.0, 1.4; placebo 4.0, 4.3, 4.3. Lumbar pain: antibiotics 6.7, 5.0, 3.7; placebo 6.3, 6.3, 6.3. For the outcome measures, where a clinically important effect size was defined, improvements exceeded the thresholds, and a trend towards a dose-response relationship with double dose antibiotics being more efficacious. CONCLUSIONS: The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.
- SourceAvailable from: rsna.orgRadiology 08/1988; 168(1):177-86. · 6.34 Impact Factor
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ABSTRACT: The authors reviewed magnetic resonance (MR) images of 474 consecutive patients referred for lumbar spine MR imaging. Type 1 changes (decreased signal intensity on T1-weighted spin-echo images and increased signal intensity on T2-weighted images) were identified in 20 patients (4%) and type 2 (increased signal intensity on T1-weighted images and isointense or slightly increased signal intensity on T2-weighted images) in 77 patients (16%). In all cases there was evidence of associated degenerative disk disease at the level of involvement. Histopathologic sections in three cases of type 1 change demonstrated disruption and fissuring of the end plates and vascularized fibrous tissue, while in three cases of type 2 change they demonstrated yellow marrow replacement. In addition, 16 patients with end-plate changes documented with MR were studied longitudinally. Type 1 changes in five of six patients converted to a type 2 pattern in 14 months to 3 years. Type 2 changes in ten patients remained stable over a 2-3-year period. These signal intensity changes appear to reflect a spectrum of vertebral body marrow changes associated with degenerative disk disease.Radiology 02/1988; 166(1 Pt 1):193-9. · 6.34 Impact Factor
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ABSTRACT: A measurement reliability study. To develop quantitative measures for Modic changes (MCs) on magnetic resonance (MR) images and evaluate measurement reliability. MCs have been studied for more than 20 years but the clinical significance remains controversial. Little effort has been made to improve the measurement of MCs. The study was approved by the responsible institutional review board. On the basis of Modic classification, a series of quantitative dimension and signal intensity measures were developed for assessing MCs. Midsagittal T1- and T2-weighted MR images from 83 lumbar spines were then qualitatively and quantitatively assessed by two observers independently. Kappa and intraclass correlation coefficient (ICC) were used to examine intra- and inter-rater reliability. Pearson correlation coefficient was used to assess the relationships between the quantitative measurements of MCs. Mean absolute deviation (MAD) and Bland-Altman plots also were used to evaluate measurement errors and limits of agreement for selected measures. For Modic classification, intrarater agreement was excellent (κ = 0.88) and inter-rater agreement was substantial (κ = 0.79). Intrarater agreement also was excellent when obtaining dimension measurements (ICC = 0.82-0.96) from T1- or T2-weighted images and inter-rater agreement was slightly greater using T1-weighted images (ICC = 0.73-0.88) than T2-weighted images (ICC = 0.66-0.82). Signal intensity measurements on T2-weighted images were found to have almost perfect intra- and inter-rater reliability (ICC = 0.92-0.99). The correlation analysis demonstrated that the quantitative measures represent different constructs. The MAD and Bland-Altman Plots further confirmed the high reliability of the area ratio, MCs mean signal intensity and MCs total signal intensity measurements. Three quantitative measures are suggested to assess the severity of MCs, which provide reliable, precise measurements for research on the etiology, pathogenesis, and clinical relevance of MCs.Spine 01/2011; 36(15):1236-43. · 2.16 Impact Factor