Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study)

Bråten, Lars Christian Haugli; Grøvle, Lars; Espeland, Ansgar; Pripp, Are Hugo; Grotle, Margreth; Helllum, Christian; Haugen, Anne Julsrud; Froholdt, Anne; Rolfsen, Mads Peder; Nygaard, Øystein P.; Lutro, Olav; Kristoffersen, Per Martin; Anke, Audny; Schistad, Elina Iordanova; Skouen, Jan Sture; Brox, Jens Ivar; Zwart, John‐Anker; Storheim, Kjersti; Wilhelmsen, Maja; Fors, Terese; Kjos, Guro; Østhus, Ida Beate Øyen; Marchand, Gunn Hege; Lurud, Britt Elin; Granvigen, Fredrik; Andersen, Hege; Rao, Vidar; Kadar, Thomas; Claussen, Siv Krüger; Andersen, Erling D.; Vetti, Nils; Aßmus, Jörg; Randen, Sigrun; Presberg, Hilde; Wigemyr, Monica; Pedersen, Linda M.; Winsvold, Bendik Slagsvold; Gammelsrud, Karianne Wiger; Vigeland, Maria Dehli; Lie, Benedicte A.; Flåm, Siri Tennebø; Vigeland, Magnus Dehli; Thorsø, Marianne; Huneide, Knut Morten; Sørensen, Veronica; Holmgard, Thor Einar

doi:10.1186/s12891-020-03422-y

Cited by 9 publications

(6 citation statements)

References 25 publications

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“…The present results support the previous clinical results of the AIM study, which did not show clinically important effects of amoxicillin compared to placebo 19,36. Interestingly, our results do not suggest a biological effect of amoxicillin on MC edema in the small subgroup with the most abundant edema at baseline 20.…”

Section: Discussionsupporting

confidence: 91%

“…The present results support the previous clinical results of the AIM study, which did not show clinically important effects of amoxicillin compared to placebo. 19,36 Interestingly, our results do not suggest a biological effect of amoxicillin on MC edema in the small subgroup with the most abundant edema at baseline. 20 We cannot exclude the possibility that MC edema may require a longer time to decline in response to amoxicillin treatment in lowgrade infectious discitis.…”

Section: Interpretation and Implicationscontrasting

confidence: 71%

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

Kristoffersen

Vetti

Grøvle

et al. 2022

Spine

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Study Design. Exploratory subgroup analyses of a randomised trial [Antibiotics in Modic changes (AIM) study]. Objective. The aim was to assess the effect of amoxicillin versus placebo in reducing Modic change (MC) edema in patients with chronic low back pain. Summary of Background Data. The AIM study showed a small, clinically insignificant effect of amoxicillin on pain-related disability in patients with chronic low back pain and MC type 1 (edema type) on magnetic resonance imaging (MRI). Materials and Methods. A total of 180 patients were randomised to receive 100 days of amoxicillin or placebo. MC edema was assessed on MRI at baseline and one-year follow-up. Per-protocol analyses were conducted in subgroups with MC edema on short tau inversion recovery (STIR) or T1/T2-weighted MRI at baseline. MC edema reductions (yes/no) in STIR and T1/T2 series were analyzed separately. The effect of amoxicillin in reducing MC edema was analyzed using logistic regression adjusted for prior disk surgery. To assess the effect of amoxicillin versus placebo within the group with the most abundant MC edema on STIR at baseline (“STIR3” group), we added age, STIR3 (yes/no), and STIR3×treatment group (interaction term) as independent variables and compared the marginal means (probabilities of edema reduction). Results. Compared to placebo, amoxicillin did not reduce MC edema on STIR (volume/intensity) in the total sample with edema on STIR at baseline (odds ratio 1.0, 95% CI: 0.5, 2.0; n=141) or within the STIR3 group (probability of edema reduction 0.69, 95% CI: 0.47, 0.92 with amoxicillin and 0.61, 95% CI: 0.43, 0.80 with placebo; n=41). Compared with placebo, amoxicillin did not reduce MC edema in T1/T2 series (volume of the type 1 part of MCs) (odds ratio: 1.0, 95% CI: 0.5, 2.3, n=104). Edema declined in >50% of patients in both treatment groups. Conclusions. From baseline to one-year follow-up, amoxicillin did not reduce MC edema compared with placebo. Level of Evidence. 2.

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Section: Discussionsupporting

confidence: 91%

Section: Interpretation and Implicationscontrasting

confidence: 71%

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

Kristoffersen

Vetti

Grøvle

et al. 2022

Spine

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“…It has been shown that in a certain subset of patients, antibiotic treatment was effective to reduce pain as well as disability ( Albert et al, 2013a ; Gilligan et al, 2021 ). However, this result has failed to be replicated in subsequent studies ( Bråten et al, 2020 ).…”

Section: The Shift From Anabolism To Catabolismmentioning

confidence: 95%

Immuno-Modulatory Effects of Intervertebral Disc Cells

Bermudez-Lekerika

Crump

Tseranidou

et al. 2022

Front. Cell Dev. Biol.

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Low back pain is a highly prevalent, chronic, and costly medical condition predominantly triggered by intervertebral disc degeneration (IDD). IDD is often caused by structural and biochemical changes in intervertebral discs (IVD) that prompt a pathologic shift from an anabolic to catabolic state, affecting extracellular matrix (ECM) production, enzyme generation, cytokine and chemokine production, neurotrophic and angiogenic factor production. The IVD is an immune-privileged organ. However, during degeneration immune cells and inflammatory factors can infiltrate through defects in the cartilage endplate and annulus fibrosus fissures, further accelerating the catabolic environment. Remarkably, though, catabolic ECM disruption also occurs in the absence of immune cell infiltration, largely due to native disc cell production of catabolic enzymes and cytokines. An unbalanced metabolism could be induced by many different factors, including a harsh microenvironment, biomechanical cues, genetics, and infection. The complex, multifactorial nature of IDD brings the challenge of identifying key factors which initiate the degenerative cascade, eventually leading to back pain. These factors are often investigated through methods including animal models, 3D cell culture, bioreactors, and computational models. However, the crosstalk between the IVD, immune system, and shifted metabolism is frequently misconstrued, often with the assumption that the presence of cytokines and chemokines is synonymous to inflammation or an immune response, which is not true for the intact disc. Therefore, this review will tackle immunomodulatory and IVD cell roles in IDD, clarifying the differences between cellular involvements and implications for therapeutic development and assessing models used to explore inflammatory or catabolic IVD environments.

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“…Finally, they proved the effectiveness of the antibiotics for Modic type 1 clinically. On the other hand, recently, a double-blind parallel-group multicentre trial to confirm the effectiveness of antibiotics for Modic changes (27). They included 180 patients, and the patients were divided into antibiotics and placebo groups.…”

Section: Antibiotics To Modic Type 1 Changementioning

confidence: 99%

A new surgical strategy for the intractable chronic low back pain due to type 1 Modic change using transforaminal full-endoscopic disc cleaning (FEDC) surgery under the local anesthesia : A case report and literature review

et al. 2021

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It has been reported that Modic change of the lumbar spine endplate includes three types: i.e. . edema or inflammation for type 1, fatty marrow change for type 2 and sclerotic change for type 3. Basically, type 1 Modic change may be related to the chronic low back pain. There are two kinds of the treatment for the type 1 Modic change to heal the pain : the anti-inflammatory drugs, and intra-discal injection of steroid. When the inflammatory change would be intractable, surgical intervention is needed. The gold standard for the surgical intervention is the segmental fusion of the affected level. The fusion surgery may cause the adjacent degeneration ; thus, motion preservation surgery is better, if possible. Our department started the motion preservation full-endoscopic intradiscal debridement surgery for this pathology, since some of the type 1 Modic change may be chronic discitis by P. Acnes. In this paper, we describe the first patient of type 1 Modic change who was successfully treated by the full-endoscopic intra-discal debridement and drainage under the local anesthesia. We named this procedure as transforaminal full-endoscopic disc cleaning surgery (FEDC). Finally, pathology, conservative and surgical intervention of Modic change was discussed.

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Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study)

Cited by 9 publications

References 25 publications

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

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

Immuno-Modulatory Effects of Intervertebral Disc Cells

A new surgical strategy for the intractable chronic low back pain due to type 1 Modic change using transforaminal full-endoscopic disc cleaning (FEDC) surgery under the local anesthesia : A case report and literature review

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