scholarly journals Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035461 ◽  
Author(s):  
Margreth Grotle ◽  
Lars Christian Bråten ◽  
Jens Ivar Brox ◽  
Ansgar Espeland ◽  
Zinajda Zolic-Karlsson ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Antibiotic Treatment ◽  
Chronic Low Back Pain ◽  
Cost Effective ◽  
Cost Utility ◽  
Modic Changes ◽  
Type I ◽  
Low Back ◽  
Utility Analysis

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.

scholarly journals Correlation between gene expression and MRI STIR signals in patients with chronic low back pain and Modic changes indicates immune involvement

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Maria Dehli Vigeland ◽  
Siri Tennebø Flåm ◽  
Magnus Dehli Vigeland ◽  
Ansgar Espeland ◽  
Per Martin Kristoffersen ◽  
...  
Keyword(s):  
Gene Expression ◽  
Low Back Pain ◽  
Back Pain ◽  
Chronic Low Back Pain ◽  
Modic Changes ◽  
Type I ◽  
Low Back ◽  
Gene Sets ◽  
Vertebral Bone Marrow ◽  
Upregulated Genes

AbstractDisability and distress caused by chronic low back pain (LBP) lacking clear pathoanatomical explanations cause huge problems both for patients and society. A subgroup of patients has Modic changes (MC), identifiable by MRI as vertebral bone marrow lesions. The cause of such changes and their relationship to pain are not yet understood. We explored the pathobiology of these lesions using profiling of gene expression in blood, coupled with an edema-sensitive MRI technique known as short tau inversion recovery (STIR) imaging. STIR images and total RNA from blood were collected from 96 patients with chronic LBP and MC type I, the most inflammatory MC state. We found the expression of 37 genes significantly associated with STIR signal volume, ten genes with edema abundancy (a constructed combination of STIR signal volume, height, and intensity), and one gene with expression levels significantly associated with maximum STIR signal intensity. Gene sets related to interferon signaling, mitochondrial metabolism and defense response to virus were identified as significantly enriched among the upregulated genes in all three analyses. Our results point to inflammation and immunological defense as important players in MC biology in patients with chronic LBP.

scholarly journals Chronic low back pain, Modic changes and low-grade virulent infection: efficacy of antibiotic treatment

2021 ◽  
pp. FSO703
Author(s):  
Claus Manniche ◽  
Gerard M Hall
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Antibiotic Treatment ◽  
Chronic Low Back Pain ◽  
Modic Changes ◽  
Controlled Study ◽  
Low Grade ◽  
Oral Antibiotic ◽  
Low Back

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.

scholarly journals Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Donna M. Urquhart ◽  
Jeffrey V. Rosenfeld ◽  
Maurits van Tulder ◽  
Anita E. Wluka ◽  
Karin Leder ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Antibiotic Treatment ◽  
Disc Herniation ◽  
Chronic Low Back Pain ◽  
Controlled Trial ◽  
Modic Changes ◽  
Low Back ◽  
Patient Subgroup ◽  
Randomised Controlled

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

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