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Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging.

ABSTRACT: Modic changes (MC) are associated with low back pain (LBP), but effective treatments are lacking. The aim of this randomized, placebo-controlled, double-blinded trial was to evaluate the efficacy of zoledronic acid (ZA) for chronic LBP among patients with MC in magnetic resonance imaging (MRI).Inclusion criteria were LBP lasting ?3 months, with an intensity of ?6 on a 10-cm VAS or an Oswestry Disability Index (ODI) of ?30%, and MC in MRI. Patients were randomized into single intravenous infusion of ZA 5 mg (n = 20), or placebo (n = 20) groups. The primary outcome was LBP intensity, secondary outcomes leg pain intensity, ODI, health-related quality of life (RAND-36), lumbar flexibility, sick leaves and use of pain medication. The treatment differences at one month and one year were analysed using ANCOVA with adjustment for the baseline score.The mean difference (MD) between the groups in the primary outcome, intensity of LBP, was 1.4 (95% confidence intervals (CI) 0.01 to 2.9) in favour of ZA at one month. We observed no significant between-group difference in the intensity of LBP at one year (MD 0.7; 95% CI -1.0 to 2.4) or in secondary outcomes at any time point except that 20% of patients in the ZA group used non-steroidal anti-inflammatory drugs at one year compared to 60% in the placebo group (P = 0.022). Acute phase reactions (fever, flu-like symptoms, arthralgia) emerged in 95% of the patients in the ZA group, compared to 35% in the placebo group.ZA was effective in reducing the intensity of LBP in the short term and in reducing the use of NSAIDs within the time span of one year among patients with chronic LBP and MC confirmed in MRI. Although the results seem encouraging, larger studies are required to analyse the effectiveness and safety of ZA for patients with MC.ClinicalTrial.gov identifier NCT01330238.

SUBMITTER: Koivisto K

PROVIDER: S-EPMC3996022 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging.

Koivisto Katri K Kyllönen Eero E Haapea Marianne M Niinimäki Jaakko J Sundqvist Kaj K Pehkonen Timo T Seitsalo Seppo S Tervonen Osmo O Karppinen Jaro J

BMC musculoskeletal disorders 20140304

<h4>Background</h4>Modic changes (MC) are associated with low back pain (LBP), but effective treatments are lacking. The aim of this randomized, placebo-controlled, double-blinded trial was to evaluate the efficacy of zoledronic acid (ZA) for chronic LBP among patients with MC in magnetic resonance imaging (MRI).<h4>Methods</h4>Inclusion criteria were LBP lasting ≥3 months, with an intensity of ≥6 on a 10-cm VAS or an Oswestry Disability Index (ODI) of ≥30%, and MC in MRI. Patients were randomiz ...[more]

PMID: 24588905

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Project description:BackgroundModic changes (MC) are associated with low back pain (LBP). In this study, we compared changes in size and type of MC, after a single intravenous infusion of 5 mg zoledronic acid (ZA) or placebo, among chronic LBP patients with MC on magnetic resonance imaging (MRI), and evaluated whether the MRI changes correlate with symptoms.MethodsAll patients (N = 19 in ZA, 20 in placebo) had MRI at baseline (0.23-1.5 T) and at one year (1.5-3 T). We evaluated the level, type and volume of all the MC. The MC were classified into M1 (M1 (100%)), predominating M1 (M1/2 (65:35%)) or predominating M2 (M1/2 (35:65%)), and M2 (M2 (100%)). The first two were considered M1-dominant, and the latter two M2-dominant. Volumes of M1 and M2 were calculated separately for the primary MC, which was assumed to cause the symptoms, and the other MC. We analysed the one-year treatment differences in M1 and M2 volumes using analysis of covariance with adjustments for age, sex, body mass index, and smoking. The correlations between the MRI changes and the changes in LBP symptoms were analysed using Pearson correlations.ResultsIn the ZA group, 84.2% of patients had M1-dominant primary MC at baseline, compared to 50% in the placebo group (p = 0.041). The primary MC in the ZA group converted more likely to M2-dominant (42.1% ZA, 15% placebo; p = 0.0119). The other MC (15 ZA, 8 placebo) were on average 42% smaller and remained largely M2-dominant. The M1 volume of the primary MC decreased in the ZA group, but increased in the placebo group (-0.83 cm3 vs 0.91 cm3; p = 0.21). The adjusted treatment difference for M1 volume was -1.9 cm3 (95% CI -5.0 to 1.2; p = 0.22) and for M2 volume 0.23 cm3 (p = 0.86). In the MC that remained M1-dominant, volume change correlated positively with increased symptoms in the placebo group, whereas the correlations were negative and weak in the ZA group.ConclusionsZoledronic acid tended to speed up the conversion of M1-dominant into M2-dominant MC and decrease the volume of M1-dominant MC, although statistical significance was not demonstrated.Trial registrationThe registration number in ClinicalTrials.gov is NCT01330238 and the date of registration February 11, 2011.

Project description:Study designRetrospective cohort study.ObjectiveTo determine the effect of early (receipt ?30 d postonset) magnetic resonance imaging (MRI) on disability and medical cost outcomes in patients with acute, disabling, work-related low back pain (LBP) with and without radiculopathy.Summary of background dataEvidence-based guidelines suggest that, except for "red flags," MRI is indicated to evaluate patients with persistent radicular pain, after 1 month of conservative management, who are candidates for surgery or epidural steroid injections. Prior research has suggested an independent iatrogenic effect of nonindicated early MRI, but it had limited clinical information and/or patient populations.MethodsA nationally representative sample of workers with acute, disabling, occupational LBP was randomly selected, oversampling those with radiculopathy diagnoses (N = 1000). Clinical information from medical reports was used to exclude cases for which early MRI might have been indicated, or MRI occurred more than 30 days postonset (final cohort = 555). Clinical information was also used to categorize cases into "nonspecific LBP" and "radiculopathy" groups and further divided into "early-MRI" and "no-MRI" subgroups. The Cox proportional hazards model examined the association of early MRI with duration of the first episode of disability. Multivariate linear regression models examined the association with medical costs. All models adjusted for demographic and medical severity measures.ResultsIn our sample, 37% of the nonspecific LBP and 79.9% of the radiculopathy cases received early MRI. The early-MRI groups had similar outcomes regardless of radiculopathy status: much lower rates of going off disability and, on average, $12,948 to $13,816 higher medical costs than the no-MRI groups. Even in a subgroup with relatively minimal disability impact (?30 d of total lost time post-MRI), medical costs were, on average, $7643 to $8584 higher in the early-MRI groups.ConclusionEarly MRI without indication has a strong iatrogenic effect in acute LBP, regardless of radiculopathy status. Providers and patients should be made aware that when early MRI is not indicated, it provides no benefits, and worse outcomes are likely.Level of evidence3.

Project description:PurposeTo conduct a 10-year longitudinal analysis of the relationship between magnetic resonance imaging (MRI) findings and low back pain (LBP).Materials and methodsNinety-one volunteers with a history of LBP, but without current LBP were recruited between 2005 and 2006. Participants' baseline demographics and MRI findings were recorded. All volunteers were invited for a follow-up MRI in 2016; of these, 49 volunteers (53.8%) participated in the follow-up. We enquired whether they had LBP history during the 10 years between the baseline and follow-up examinations. Sagittal T1 and T2-weighted MRI were used to assess the intervertebral space from T12/L1 to L5/S1. We evaluated the presence of disc degeneration by Pfirrmann's grading system, disc bulging, high intensity zone (HIZ), spondylolisthesis, and any type of Modic changes in the follow-up MRIs. We compared the follow-up MRI findings with the baseline findings; the progress of each finding over the 10 years were also compared between the groups with (n = 36) and without (n = 13) LBP.ResultsAverage age of the study participants at follow-up was 44.8 years; 25 were female and 24 were male. Average age, sex, body mass index, and smoking habits of those who did and did not participate in the follow-up study, as well as the demographic characteristics of those who did and did not have LBP history during the 10 years, were not significantly different. Compared with the group without LBP history, the group that had LBP history during the 10 years did not have a significantly increased prevalence of disc degeneration, disc bulging, and HIZ in the follow-up and baseline MRIs. Spondylolisthesis and any type of Modic changes were also not associated with LBP history during the 10 years.ConclusionsFollow-up MRI findings consistent with Pfirrmann grading ≥4, disc bulging, HIZ, spondylolisthesis, and any type of Modic changes were not associated with LBP history during the 10 years between the baseline and follow-up study. The progresses of these findings were also not associated with the LBP history. In addition, baseline MRI findings were not associated with LBP history during the 10 years; therefore, our data suggest that baseline MRI findings cannot predict future LBP.

Project description:BackgroundPrevious systematic reviews have reported positive associations between Modic changes (MCs) and low back pain (LBP), but due to their narrow scope and new primary studies, there is a need for a comprehensive systematic review. Our objectives were to investigate if MCs are associated with non-specific LBP and/or activity limitation and if such associations are modified by other factors.MethodsA protocol for this review was registered at PROSPERO prior to commencing the work (PROSPERO record: CRD42015017350). The MEDLINE, CINAHL and EMBASE databases were searched for relevant studies from first record to June 15th 2016. Prospective or retrospective cross-sectional cohort studies and case-control studies including people of all ages from general, working and clinical study populations were eligible for inclusion. Risk of bias assessment and data extraction for associations and potential modifiers were completed independently by pairs of reviewers. Meta-analysis was performed for homogeneous studies and presented as odds ratios (OR) with 95% CI.ResultsIn all, 5210 citations were identified and 31 studies were included. One study had low risk of bias. Fifteen studies (48%) reported statistically significant positive associations between MCs and LBP and one study found a statistically significant negative association. Meta-analysis performed for studies using concordant pain with provocative discography as the clinical outcome resulted in an OR of 4.01 (1.52-10.61). One of seven studies reported a statistically significant positive association between MCs and activity limitation. Lumbar disc level and disc degeneration were found to modify the association between MCs and LBP.ConclusionsThe results from this comprehensive systematic review indicate that the associations between MCs and LBP-related outcomes are inconsistent. The high risk of bias and the heterogeneity in terms of study samples, clinical outcomes and prevalence estimates of MCs and LBP may explain these findings. It is likely that new studies with low risk of bias will affect the direction and strength of these associations.

Project description:ObjectiveThe purposes of this study were to use functional magnetic resonance imaging to investigate the immediate changes in functional connectivity (FC) between brain regions that process and modulate the pain experience after 3 different types of manual therapies (MT) and to identify reductions in experimentally induced myalgia and changes in local and remote pressure pain sensitivity.MethodsTwenty-four participants (17 men; mean age ± SD, 21.6 ± 4.2 years) who completed an exercise-injury protocol to induce low back pain were randomized into 3 groups: chiropractic spinal manipulation (n = 6), spinal mobilization (n = 8), or therapeutic touch (n = 10). The primary outcome was the immediate change in FC as measured on functional magnetic resonance imaging between the following brain regions: somatosensory cortex, secondary somatosensory cortex, thalamus, anterior and posterior cingulate cortices, anterior and poster insula, and periaqueductal gray. Secondary outcomes were immediate changes in pain intensity, measured with a 101-point numeric rating scale, and pain sensitivity, measured with a handheld dynamometer. Repeated-measures analysis of variance models and correlation analyses were conducted to examine treatment effects and the relationship between within-person changes across outcome measures.ResultsChanges in FC were found between several brain regions that were common to all 3 MT interventions. Treatment-dependent changes in FC were also observed between several brain regions. Improvement was seen in pain intensity after all interventions (P < .05) with no difference between groups (P > .05). There were no observed changes in pain sensitivity, or an association between primary and secondary outcome measures.ConclusionThese results suggest that MTs (chiropractic spinal manipulation, spinal mobilization, and therapeutic touch) have an immediate effect on the FC between brain regions involved in processing and modulating the pain experience. This suggests that neurophysiologic changes after MT may be an underlying mechanism of pain relief.

Project description:OBJECTIVE:To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). DESIGN:Double blind, parallel group, placebo controlled, multicentre trial. SETTING:Hospital outpatient clinics at six hospitals in Norway. PARTICIPANTS:180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. INTERVENTIONS:Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. MAIN OUTCOME MEASURES:The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. RESULTS:In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was -1.6 (95% confidence interval -3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was -2.3 (-4.2 to-0.4, P=0.02) for patients with type 1 Modic changes and -0.1 (-2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. CONCLUSIONS:In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes. TRIAL REGISTRATION:ClinicalTrials.gov NCT02323412.

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Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging.

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Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging.

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