Albert HB, Sorensen JS, Christensen BS, et al. 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

Research Department, Spine Centre of Southern Denmark, Institute of Regional Health Services Research, Lillebaelt Hospital, University of Southern Denmark, Middelfart, Denmark, .
European Spine Journal (Impact Factor: 2.07). 02/2013; 22(4). DOI: 10.1007/s00586-013-2675-y
Source: PubMed


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). 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. 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). 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. 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.

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    • "Even when asymptomatic , extrusions cause disc narrowing and can lead to instability, spondylolisthesis and facet joint degeneration . Moreover, recent evidence suggests that extrusions can act as gateways to bacterial infection of the nucleus, associated with chronic LBP [47] [48]. It is therefore reasonable to suppose that conservative managements , which facilitate healing of extrusions, could reduce progression to long-term, disabling LBP. "
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    ABSTRACT: BACKGROUND: Previous trials of yoga therapy for nonspecific low back pain (nsLBP) (without sciatica) showed beneficial effects. OBJECTIVE: To test effects of yoga therapy on pain and disability associated with lumbar disc extrusions and bulges. METHODS: Parallel-group, randomised, controlled trial. Sixty-one adults from rural population, aged 20-45, with nsLBP or sciatica, and disc extrusions or bulges. Randomised to yoga (n=30) and control (n=31). Yoga: 3-month yoga course of group classes and home practice, designed to ensure safety for disc extrusions. Control: normal medical care. OUTCOME MEASURES (3-4 months) Primary: Roland Morris Disability Questionnaire (RMDQ); worst pain in past two weeks. Secondary: Aberdeen Low Back Pain Scale; straight leg raise test; structural changes. RESULTS: Disc projections per case ranged from one bulge or one extrusion to three bulges plus two extrusions. Sixty-two percent had sciatica. Intention-to-treat analysis of the RMDQ data, adjusted for age, sex and baseline RMDQ scores, gave a Yoga Group score 3.29 points lower than Control Group (0.98, 5.61; p=0.006) at 3 months. No other significant differences in the endpoints occurred. No adverse effects of yoga were reported. CONCLUSIONS: Yoga therapy can be safe and beneficial for patients with nsLBP or sciatica, accompanied by disc extrusions and bulges.
    Full-text · Article · Sep 2014 · Journal of Back and Musculoskeletal Rehabilitation
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    • "We identified as suitable for inclusion in our systematic review 31 publications [4,10-39] reporting on 27 datasets from randomised placebo-controlled trials in chronic painful diseases or rheumatic diseases (Table 1). Typically such a dataset corresponds to data from one clinical trial. "
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    ABSTRACT: Background Chronic painful conditions have an important influence on the ability to work. Work-related outcomes, however, are not commonly reported in publications on trials investigating the treatment of chronic painful conditions. We aim to provide an overview of the reporting of work-related outcomes in such trials and investigate the relationship between work-related outcomes and pain outcomes. Methods We conducted a systematic literature search in PubMed with the aim of identifying randomised placebo-controlled clinical trials investigating treatments for chronic painful conditions or rheumatic diseases that also reported on work-related outcomes. Methodological study quality was assessed with the Oxford Quality Scale (OQS). Meta-analyses were conducted for the outcomes of interference with work and number of patients with at least 30% reduction in pain intensity (30% pain responders). The correlation between work-related and pain outcomes was investigated with regression analyses. Results We included 31 publications reporting on 27 datasets from randomised placebo-controlled trials (with a total of 11,434 study participants) conducted in chronic painful or rheumatic diseases and reporting on work-related outcomes. These 31 publications make up only about 0.2% of all publications on randomised placebo-controlled trials in such conditions. The methodological quality of the included studies was high; only nine studies scored less than four (out of a maximum five) points on the OQS. Sixteen different work-related outcomes were reported on in the studies. Of 25 studies testing for the statistical significance of changes in work-related outcomes over the course of the trials, 14 (56%) reported a significant improvement; the others reported non-significant changes. Eight studies reported data on both interference with work and 30% pain responders: meta-analyses demonstrated similar, statistically significant improvements in both these outcomes with active therapy compared to placebo and regression analysis showed that these outcomes were correlated. Conclusions Despite the importance of pain as a reason for decreased ability to work, work-related outcomes are reported in substantially less than 1% of publications on placebo-controlled trials in chronic painful and rheumatic diseases. Work-related outcomes and pain responder outcomes are closely related.
    Full-text · Article · Jul 2014 · Journal of Occupational Medicine and Toxicology
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    • "The presence of Modic changes had no negative influence on outcomes in two of these studies [22] [23] but were linked to a poor outcome in the third study [17]. To further complicate matters, after years of considering Modic changes as a distinct diagnosis from spinal infection, a randomized clinical trial has recently been published which showed that patients with Modic type I changes undergoing a long course of antibiotics (100 days) had highly significantly better outcomes compared to patients taking the placebo medication [24]. Most of the studies investigating the relationships between the presence of Modic changes and clinical symptoms or treatment outcomes focused on patients with so-called 'non-specific' low back pain. "
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    ABSTRACT: OBJECTIVE: To compare outcomes after imaging-guided transforaminal lumbar nerve root blocks in MRI confirmed symptomatic disc herniation patients with and without Modic changes (MC). METHODS: Consecutive adult patients with MRI confirmed symptomatic lumbar disc herniations and an imaging-guided lumbar nerve root block injection who returned an outcomes questionnaire are included. Numerical rating scale (NRS) pain data was collected prior to injection and 20-30 min after injection. NRS and overall improvement were assessed using the patient's global impression of change (PGIC) scale at 1 day, 1 week and 1 month post injection. The proportion of patients with and without MC on MRI as well as Modic I and Modic II was calculated. These groups were compared for clinically relevant 'improvement' using the Chi-squared test. Baseline and follow-up NRS scores were compared for the groups using the unpaired t-test. RESULTS: 346 patients are included with MC present in 57%. A higher percentage of patients without MC reported 'improvement' and a higher percentage of patients with MC reported 'worsening' but this did not reach statistical significance. The numerical scores on the PGIC and NRS scales showed that patients with MC had significantly higher pain and worse overall improvement scores at 1 month (p=0.048 and p=0.03) and a significantly lower 1 month NRS change score (p=0.04). CONCLUSIONS: Patients with MRI confirmed symptomatic lumbar disc herniations and MC report significantly lower levels of pain reduction after a lumbar nerve root block compared to patients without MC.
    Full-text · Article · Jun 2014 · European Journal of Radiology
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