No. 257 Modic Changes: Antibiotic Treatment in Chronic Low Back Pain Patients With a Suspected Low Grade Discitis

PM&R ◽  
2014 ◽  
Vol 6 (8) ◽  
pp. S143
Author(s):  
Claus Manniche ◽  
Lars Morsø ◽  
Lene Kiertzner
2021 ◽  
pp. FSO703
Author(s):  
Claus Manniche ◽  
Gerard M Hall

Chronic low back pain (CLBP) has consistently been associated with the longest number of years lived with a disability in global studies, while commonly used treatments for CLBP are largely ineffective. In 2013 a randomized, double-blind, controlled study demonstrated significant improvements in CLBP patients demonstrating Modic changes type 1 on their MRI scans and undergoing long-term oral antibiotic treatment (100 days). Much of the ensuing debate has focused on whether this was a true infection or contamination. Newer and more advanced technologies clearly point to an ongoing low-grade infection. We have reviewed all of the clinical trials published in the recent past and conclude that there is compelling evidence for the effect of long-term oral antibiotic treatment for this patient group.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035461 ◽  
Author(s):  
Margreth Grotle ◽  
Lars Christian Bråten ◽  
Jens Ivar Brox ◽  
Ansgar Espeland ◽  
Zinajda Zolic-Karlsson ◽  
...  

ObjectiveTo evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study.DesignA cost–utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.SettingHospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect.Participants180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91).InterventionsOral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.Main outcome measuresQuality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost–utility was expressed in incremental cost-effectiveness ratio (ICER).ResultsMean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; −3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%.ConclusionsAmoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.Trial registration numberClinicalTrials.gov NCT02323412.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Donna M. Urquhart ◽  
Jeffrey V. Rosenfeld ◽  
Maurits van Tulder ◽  
Anita E. Wluka ◽  
Karin Leder ◽  
...  

Abstract Background There has been immense interest and debate regarding the effectiveness of antibiotic treatment for chronic low back pain. Two randomised controlled trials have examined the efficacy of antibiotics for chronic low back pain with disc herniation and Modic changes, but have reported conflicting results. The aim of this double-blind, randomised, placebo-controlled trial is to determine the efficacy of antibiotic treatment in a broader patient subgroup of chronic low back pain with disc herniation and investigate whether the presence of Modic changes predicts response to antibiotic therapy. Methods One hundred and seventy individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics; advertising in national, community and social media; and posting of flyers in community locations. They will be randomly allocated to receive either amoxicillin-clavulanate (500 mg/125 mg) twice per day for 90 days or placebo. The primary outcome measure of pain intensity will be assessed using the Low Back Pain Rating scale and a 100-mm visual analogue scale at 12 months. Secondary measures of self-reported low back disability and work absence and hindrance will also be examined, and an economic analysis will be conducted. Intention-to-treat analyses will be performed. Discussion There is uncertainty about whether antibiotic treatment is effective for chronic low back pain and, if effective, which patient subgroup is most likely to respond. We will conduct a clinical trial to investigate the efficacy of antibiotics compared with placebo in individuals with chronic low back pain and a disc herniation. Our findings will provide high-quality evidence to assist in answering these questions. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12615000958583. Registered on 11 September 2015


2011 ◽  
Vol 11 (5) ◽  
pp. 402-411 ◽  
Author(s):  
Estanislao Arana ◽  
Francisco M. Kovacs ◽  
Ana Royuela ◽  
Ana Estremera ◽  
Beatriz Asenjo ◽  
...  

BMJ ◽  
2019 ◽  
pp. l5654 ◽  
Author(s):  
Lars Christian Haugli Bråten ◽  
Mads Peder Rolfsen ◽  
Ansgar Espeland ◽  
Monica Wigemyr ◽  
Jörg Aßmus ◽  
...  

Abstract 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 .


2016 ◽  
Vol 6 (1_suppl) ◽  
pp. s-0036-1582898-s-0036-1582898
Author(s):  
Claus Manniche ◽  
Lars Morsø ◽  
Lene Kiertzner

Sign in / Sign up

Export Citation Format

Share Document