Amoxicillin did not Reduce Modic Change Oedema in Patients with Chronic Low Back pain - subgroup Analyses of a Randomised Trial (the AIM study)

Kristoffersen, Per Martin; Vetti, Nils; Grøvle, Lars; Brox, Jens Ivar; Bråten, Lars Christian Haugli; Grotle, Margreth; Haugen, Anne Julsrud; Rolfsen, Mads Peder; Froholdt, Anne; Skouen, Jan Sture; Lutro, Olav; Marchand, Gunn Hege; Anke, Audny; Zwart, John‐Anker; Storheim, Kjersti; Aßmus, Jörg; Espeland, Ansgar

doi:10.1097/brs.0000000000004513

Cited by 3 publications

(7 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The interrater agreement (mean kappa) among the 3 radiologists was very good for the presence of MC edema on STIR/MC1 (0.86/0.81) 21 and good for STIR change/MC1 change (0.71/0.74). 22 Two of the radiologists rated the highest disc degeneration (DD) Pfirrmann grade (Table 1) at an index level with good interrater agreement (linearly weighted kappa 0.66 in the current study sample, n = 162). Disagreements were solved in consensus and relevant analyses were adjusted for DD grade.…”

Section: The Current Studymentioning

confidence: 72%

“…STIR3 represented the most abundant edema and is defined in Table 1. The interrater agreement (mean kappa) among the 3 radiologists was very good for the presence of MC edema on STIR/MC1 (0.86/0.81) 21 and good for STIR change/MC1 change (0.71/0.74) 22 …”

Section: Methodsmentioning

confidence: 90%

“…This study focused on MRI findings at the index level(s), that is, level(s) with a prior disc herniation and MC1 or MC2 at baseline. All MC-related MRI variables were defined in the SAP (available at ClinicalTrials.gov) and have been described, 22,26 and are shown in Table 1. Three radiologists blinded to clinical outcome and treatment group independently rated all MRIs using clinical picture archiving and communication system workstations.…”

Section: The Current Studymentioning

confidence: 99%

“…Subsequent analysis also indicated an effect in a small subgroup with abundant baseline MC edema on STIR (“STIR3” group, defined further) 21 . However, amoxicillin did not reduce MC edema compared with placebo 22 . The purpose of the current study was to assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic LBP.…”

mentioning

confidence: 94%

“…21 However, amoxicillin did not reduce MC edema compared with placebo. 22 The purpose of the current study was to assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic LBP.…”

mentioning

confidence: 99%

See 4 more Smart Citations

Longitudinal Relationship between Reduced Modic change Edema and Disability and Pain in Patients with Chronic Low Back Pain

Espeland,

Kristoffersen,

Bråten

et al. 2023

Spine

Self Cite

View full text Add to dashboard Cite

Study Design. Secondary analyses of a randomized trial (Antibiotics In Modic changes (AIM) study). Objective. To assess whether or not reduced Modic change (MC) edema over time is related to reduced disability and pain in patients with chronic low back pain (LBP). Summary of Background Data. It is not clear whether or not reduced MC oedema implies improved clinical outcomes. Methods. Linear regression was conducted separately in two subgroups with MC oedema at baseline on short tau inversion recovery (STIR) or T1/T2-weigthed magnetic resonance imaging, respectively. Independent variable: reduced edema (yes/no) at 1 year on STIR or T1/T2-series, respectively. Dependent variable: 1-year score on the Roland Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), or 0–10 numeric rating scale for LBP intensity, adjusted for the baseline score, age, smoking, body mass index, physical workload, and baseline edema on STIR (STIR analysis only). Post-hoc, we additionally adjusted all analyses for baseline edema on STIR, treatment group (amoxicillin/placebo) and prior disc surgery – or for disc degeneration. Results. Among patients with MC edema on STIR at baseline (n=162), reduced edema on STIR was not significantly related to the RMDQ (B -1.0, 95% CI -2.8, 0.8; P=0.27), ODI (B -1.4, 95% CI -5.4, 2.6; P=0.50) or LBP intensity scores (B -0.05, 95% CI -0.8, 0.7; P=0.90) after 1 year. Among patients with MC edema on T1/T2-series at baseline (n=116), reduced edema on T1/T2 (i.e., reduced volume of the type 1 part of MCs) was not significantly related to RMDQ (B -1.7, 95% CI -3.8, 0.3; P=0.10) or ODI score (B -2.3, 95%CI -7.1, 2.5; P=0.34) but was significantly related to LBP intensity at 1 year (B -0.9, 95% CI -1.8, -0.04; P=0.04; correlation coefficient 0.24). The post-hoc analyses supported these results. Conclusion. Reduced MC edema over 1 year was not significantly associated with pain-related disability but was (on T1/T2-series) significantly but weakly related to reduced LBP intensity. Level of evidence. 3.

show abstract

Section: The Current Studymentioning

confidence: 72%

Section: Methodsmentioning

confidence: 90%

Section: The Current Studymentioning

confidence: 99%

mentioning

confidence: 94%

mentioning

confidence: 99%

See 3 more Smart Citations

Longitudinal Relationship between Reduced Modic change Edema and Disability and Pain in Patients with Chronic Low Back Pain

Espeland,

Kristoffersen,

Bråten

et al. 2023

Spine

Self Cite

View full text Add to dashboard Cite

show abstract

The efficacy and safety of oral antibiotic treatment in patients with chronic low back pain and Modic changes: A systematic review and meta‐analysis

Wong,

Mallow,

Pinto

et al. 2023

JOR Spine

View full text Add to dashboard Cite

BackgroundThis systematic review and meta‐analysis aimed to summarize evidence regarding the effectiveness and safety of oral antibiotic intervention for chronic low back pain (CLBP) patients with/without type‐1 Modic changes (MC1).MethodsAMED, CINAHL, Cochrane Library, Embase, and Medline were searched from inception to March 3, 2023. Randomized controlled trials (RCTs) or non‐RCTs that investigated the effectiveness or safety of oral antibiotics in treating CLBP patients were eligible for inclusion. Two independent reviewers screened abstracts, full‐text articles, and extracted data. The methodological quality of each included article were evaluated by RoB2 and NIH quality assessment tools. The quality of evidence was appraised by GRADE. Meta‐analyses were performed, where applicable. A subgroup analysis was conducted to evaluate the RCTs and case series separately, and to evaluate the effect of removing a low‐quality RCT.ResultsThree RCTs and four case series were included. All Amoxicillin‐clavulanate/Amoxicillin treatments lasted for approximately 3 months. Moderate‐ and low‐quality evidence suggested that antibiotic was significantly better than placebo in improving disability and quality of life in CLBP patients with MC1 at 12‐month follow‐up, respectively. Low‐quality evidence from meta‐analyses of RCTs showed that oral antibiotic was significantly better than placebo in improving pain and disability in CLBP patients with MC1 immediately post‐treatment. Very low‐quality evidence from the case series suggested that oral Amoxicillin‐clavulanate significantly improved LBP/leg pain, and LBP‐related disability. Conversely, low‐quality evidence found that oral Amoxicillin alone was not significantly better than placebo in improving global perceived health in patients with CLBP at the 12‐month follow‐up. Additionally, oral antibiotic users had significantly more adverse effects than placebo users.ConclusionsAlthough oral antibiotics were statistically superior to placebo in reducing LBP‐related disability in patients with CLBP and concomitant MC1, its clinical significance remains uncertain. Future large‐scale high‐quality RCTs are warranted to validate the effectiveness of antibiotics in individuals with CLBP.

show abstract

Intradiscal pharmacokinetics of oral antibiotics to treat Chronic Lower Back Pain

Czaplewski¹,

Zeitlinger

Standing

2023

npj Antimicrob Resist

View full text Add to dashboard Cite

Oral coamoxiclav and amoxicillin, for extended dose regimens of up to 100 days, have shown benefit in the treatment of Chronic Lower Back Pain (CLBP) associated with vertebral bone oedema, known as Modic type 1 changes, which may be caused by a bacterial infection, but the magnitude of clinical improvement has been variable. The objectives of this review were to use sparse data from the literature to estimate the exposure of amoxicillin in the intervertebral disc, and to determine whether adequate antimicrobial exposure may have been achieved. Exposure to amoxicillin in herniated disc tissue was approximately 6.5% of the serum concentration. Dosing of oral amoxicillin, Q12h, at doses of up to 1,000 mg is unlikely to lead to effective exposure in disc tissue. Mean exposure to 500 mg or 750 mg of oral Q8h amoxicillin may reach the efficacy target for ~50% of Cutibacterium acnes strains, but not for 90% of C. acnes strains. Mean exposure to 1,000 mg of oral amoxicillin Q8h may reach the target exposure for 90% of strains. Oral amoxicillin CLBP studies may all be underdosed. More than 1400 patients with CLBP and Modic type 1 changes have been exposed to oral amoxicillin for up to 100 days, with no apparent evaluation of systemic or intradiscal pharmacokinetics. Additional clinical evaluations of amoxicillin and alternative antibiotics, their dose regimens, and intradiscal pharmacokinetics are warranted to optimize treatment for this indication. Expertise in antibacterial pharmacokinetics and pharmacodynamics should be included in the design and execution of future studies.

show abstract

Amoxicillin did not Reduce Modic Change Oedema in Patients with Chronic Low Back pain - subgroup Analyses of a Randomised Trial (the AIM study)

Cited by 3 publications

References 38 publications

Longitudinal Relationship between Reduced Modic change Edema and Disability and Pain in Patients with Chronic Low Back Pain

Longitudinal Relationship between Reduced Modic change Edema and Disability and Pain in Patients with Chronic Low Back Pain

The efficacy and safety of oral antibiotic treatment in patients with chronic low back pain and Modic changes: A systematic review and meta‐analysis

Intradiscal pharmacokinetics of oral antibiotics to treat Chronic Lower Back Pain

Contact Info

Product

Resources

About