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)
Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the prese...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Bråten, Lars Christian Haugli [verfasserIn] Grøvle, Lars [verfasserIn] Espeland, Ansgar [verfasserIn] Pripp, Are Hugo [verfasserIn] Grotle, Margreth [verfasserIn] Helllum, Christian [verfasserIn] Haugen, Anne Julsrud [verfasserIn] Froholdt, Anne [verfasserIn] Rolfsen, Mads Peder [verfasserIn] Nygaard, Øystein Petter [verfasserIn] Lutro, Olav [verfasserIn] Kristoffersen, Per Martin [verfasserIn] Anke, Audny [verfasserIn] Schistad, Elina Iordanova [verfasserIn] Skouen, Jan Sture [verfasserIn] Brox, Jens Ivar [verfasserIn] Zwart, John-Anker [verfasserIn] Storheim, Kjersti [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2020 |
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| Übergeordnetes Werk: |
Enthalten in: BMC musculoskeletal disorders - London : BioMed Central, 2000, 21(2020), 1 vom: 13. Juli |
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| Übergeordnetes Werk: |
volume:21 ; year:2020 ; number:1 ; day:13 ; month:07 |
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| DOI / URN: |
10.1186/s12891-020-03422-y |
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| Katalog-ID: |
SPR040325636 |
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| 245 | 1 | 0 | |a 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) |
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| 520 | |a Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. | ||
| 650 | 4 | |a Chronic low back pain |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Modic changes |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Antibiotic |7 (dpeaa)DE-He213 | |
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| 650 | 4 | |a Infection |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Grøvle, Lars |e verfasserin |4 aut | |
| 700 | 1 | |a Espeland, Ansgar |e verfasserin |4 aut | |
| 700 | 1 | |a Pripp, Are Hugo |e verfasserin |4 aut | |
| 700 | 1 | |a Grotle, Margreth |e verfasserin |4 aut | |
| 700 | 1 | |a Helllum, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Haugen, Anne Julsrud |e verfasserin |4 aut | |
| 700 | 1 | |a Froholdt, Anne |e verfasserin |4 aut | |
| 700 | 1 | |a Rolfsen, Mads Peder |e verfasserin |4 aut | |
| 700 | 1 | |a Nygaard, Øystein Petter |e verfasserin |4 aut | |
| 700 | 1 | |a Lutro, Olav |e verfasserin |4 aut | |
| 700 | 1 | |a Kristoffersen, Per Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Anke, Audny |e verfasserin |4 aut | |
| 700 | 1 | |a Schistad, Elina Iordanova |e verfasserin |4 aut | |
| 700 | 1 | |a Skouen, Jan Sture |e verfasserin |4 aut | |
| 700 | 1 | |a Brox, Jens Ivar |e verfasserin |4 aut | |
| 700 | 1 | |a Zwart, John-Anker |e verfasserin |4 aut | |
| 700 | 1 | |a Storheim, Kjersti |e verfasserin |4 aut | |
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10.1186/s12891-020-03422-y doi (DE-627)SPR040325636 (SPR)s12891-020-03422-y-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Bråten, Lars Christian Haugli verfasserin aut 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) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. Chronic low back pain (dpeaa)DE-He213 Modic changes (dpeaa)DE-He213 Antibiotic (dpeaa)DE-He213 Effect modifier (dpeaa)DE-He213 Subgroup (dpeaa)DE-He213 Randomised (dpeaa)DE-He213 Infection (dpeaa)DE-He213 Grøvle, Lars verfasserin aut Espeland, Ansgar verfasserin aut Pripp, Are Hugo verfasserin aut Grotle, Margreth verfasserin aut Helllum, Christian verfasserin aut Haugen, Anne Julsrud verfasserin aut Froholdt, Anne verfasserin aut Rolfsen, Mads Peder verfasserin aut Nygaard, Øystein Petter verfasserin aut Lutro, Olav verfasserin aut Kristoffersen, Per Martin verfasserin aut Anke, Audny verfasserin aut Schistad, Elina Iordanova verfasserin aut Skouen, Jan Sture verfasserin aut Brox, Jens Ivar verfasserin aut Zwart, John-Anker verfasserin aut Storheim, Kjersti verfasserin aut Enthalten in BMC musculoskeletal disorders London : BioMed Central, 2000 21(2020), 1 vom: 13. Juli (DE-627)326643745 (DE-600)2041355-5 1471-2474 nnns volume:21 year:2020 number:1 day:13 month:07 https://dx.doi.org/10.1186/s12891-020-03422-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 13 07 |
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10.1186/s12891-020-03422-y doi (DE-627)SPR040325636 (SPR)s12891-020-03422-y-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Bråten, Lars Christian Haugli verfasserin aut 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) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. Chronic low back pain (dpeaa)DE-He213 Modic changes (dpeaa)DE-He213 Antibiotic (dpeaa)DE-He213 Effect modifier (dpeaa)DE-He213 Subgroup (dpeaa)DE-He213 Randomised (dpeaa)DE-He213 Infection (dpeaa)DE-He213 Grøvle, Lars verfasserin aut Espeland, Ansgar verfasserin aut Pripp, Are Hugo verfasserin aut Grotle, Margreth verfasserin aut Helllum, Christian verfasserin aut Haugen, Anne Julsrud verfasserin aut Froholdt, Anne verfasserin aut Rolfsen, Mads Peder verfasserin aut Nygaard, Øystein Petter verfasserin aut Lutro, Olav verfasserin aut Kristoffersen, Per Martin verfasserin aut Anke, Audny verfasserin aut Schistad, Elina Iordanova verfasserin aut Skouen, Jan Sture verfasserin aut Brox, Jens Ivar verfasserin aut Zwart, John-Anker verfasserin aut Storheim, Kjersti verfasserin aut Enthalten in BMC musculoskeletal disorders London : BioMed Central, 2000 21(2020), 1 vom: 13. Juli (DE-627)326643745 (DE-600)2041355-5 1471-2474 nnns volume:21 year:2020 number:1 day:13 month:07 https://dx.doi.org/10.1186/s12891-020-03422-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 13 07 |
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10.1186/s12891-020-03422-y doi (DE-627)SPR040325636 (SPR)s12891-020-03422-y-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Bråten, Lars Christian Haugli verfasserin aut 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) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. Chronic low back pain (dpeaa)DE-He213 Modic changes (dpeaa)DE-He213 Antibiotic (dpeaa)DE-He213 Effect modifier (dpeaa)DE-He213 Subgroup (dpeaa)DE-He213 Randomised (dpeaa)DE-He213 Infection (dpeaa)DE-He213 Grøvle, Lars verfasserin aut Espeland, Ansgar verfasserin aut Pripp, Are Hugo verfasserin aut Grotle, Margreth verfasserin aut Helllum, Christian verfasserin aut Haugen, Anne Julsrud verfasserin aut Froholdt, Anne verfasserin aut Rolfsen, Mads Peder verfasserin aut Nygaard, Øystein Petter verfasserin aut Lutro, Olav verfasserin aut Kristoffersen, Per Martin verfasserin aut Anke, Audny verfasserin aut Schistad, Elina Iordanova verfasserin aut Skouen, Jan Sture verfasserin aut Brox, Jens Ivar verfasserin aut Zwart, John-Anker verfasserin aut Storheim, Kjersti verfasserin aut Enthalten in BMC musculoskeletal disorders London : BioMed Central, 2000 21(2020), 1 vom: 13. Juli (DE-627)326643745 (DE-600)2041355-5 1471-2474 nnns volume:21 year:2020 number:1 day:13 month:07 https://dx.doi.org/10.1186/s12891-020-03422-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 13 07 |
| allfieldsGer |
10.1186/s12891-020-03422-y doi (DE-627)SPR040325636 (SPR)s12891-020-03422-y-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Bråten, Lars Christian Haugli verfasserin aut 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) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. Chronic low back pain (dpeaa)DE-He213 Modic changes (dpeaa)DE-He213 Antibiotic (dpeaa)DE-He213 Effect modifier (dpeaa)DE-He213 Subgroup (dpeaa)DE-He213 Randomised (dpeaa)DE-He213 Infection (dpeaa)DE-He213 Grøvle, Lars verfasserin aut Espeland, Ansgar verfasserin aut Pripp, Are Hugo verfasserin aut Grotle, Margreth verfasserin aut Helllum, Christian verfasserin aut Haugen, Anne Julsrud verfasserin aut Froholdt, Anne verfasserin aut Rolfsen, Mads Peder verfasserin aut Nygaard, Øystein Petter verfasserin aut Lutro, Olav verfasserin aut Kristoffersen, Per Martin verfasserin aut Anke, Audny verfasserin aut Schistad, Elina Iordanova verfasserin aut Skouen, Jan Sture verfasserin aut Brox, Jens Ivar verfasserin aut Zwart, John-Anker verfasserin aut Storheim, Kjersti verfasserin aut Enthalten in BMC musculoskeletal disorders London : BioMed Central, 2000 21(2020), 1 vom: 13. Juli (DE-627)326643745 (DE-600)2041355-5 1471-2474 nnns volume:21 year:2020 number:1 day:13 month:07 https://dx.doi.org/10.1186/s12891-020-03422-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 13 07 |
| allfieldsSound |
10.1186/s12891-020-03422-y doi (DE-627)SPR040325636 (SPR)s12891-020-03422-y-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Bråten, Lars Christian Haugli verfasserin aut 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) 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. Chronic low back pain (dpeaa)DE-He213 Modic changes (dpeaa)DE-He213 Antibiotic (dpeaa)DE-He213 Effect modifier (dpeaa)DE-He213 Subgroup (dpeaa)DE-He213 Randomised (dpeaa)DE-He213 Infection (dpeaa)DE-He213 Grøvle, Lars verfasserin aut Espeland, Ansgar verfasserin aut Pripp, Are Hugo verfasserin aut Grotle, Margreth verfasserin aut Helllum, Christian verfasserin aut Haugen, Anne Julsrud verfasserin aut Froholdt, Anne verfasserin aut Rolfsen, Mads Peder verfasserin aut Nygaard, Øystein Petter verfasserin aut Lutro, Olav verfasserin aut Kristoffersen, Per Martin verfasserin aut Anke, Audny verfasserin aut Schistad, Elina Iordanova verfasserin aut Skouen, Jan Sture verfasserin aut Brox, Jens Ivar verfasserin aut Zwart, John-Anker verfasserin aut Storheim, Kjersti verfasserin aut Enthalten in BMC musculoskeletal disorders London : BioMed Central, 2000 21(2020), 1 vom: 13. Juli (DE-627)326643745 (DE-600)2041355-5 1471-2474 nnns volume:21 year:2020 number:1 day:13 month:07 https://dx.doi.org/10.1186/s12891-020-03422-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 13 07 |
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Enthalten in BMC musculoskeletal disorders 21(2020), 1 vom: 13. Juli volume:21 year:2020 number:1 day:13 month:07 |
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Chronic low back pain Modic changes Antibiotic Effect modifier Subgroup Randomised Infection |
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Bråten, Lars Christian Haugli @@aut@@ Grøvle, Lars @@aut@@ Espeland, Ansgar @@aut@@ Pripp, Are Hugo @@aut@@ Grotle, Margreth @@aut@@ Helllum, Christian @@aut@@ Haugen, Anne Julsrud @@aut@@ Froholdt, Anne @@aut@@ Rolfsen, Mads Peder @@aut@@ Nygaard, Øystein Petter @@aut@@ Lutro, Olav @@aut@@ Kristoffersen, Per Martin @@aut@@ Anke, Audny @@aut@@ Schistad, Elina Iordanova @@aut@@ Skouen, Jan Sture @@aut@@ Brox, Jens Ivar @@aut@@ Zwart, John-Anker @@aut@@ Storheim, Kjersti @@aut@@ |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR040325636</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519160442.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2020 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s12891-020-03422-y</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR040325636</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s12891-020-03422-y-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">ASE</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.00</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Bråten, Lars Christian Haugli</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. 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Bråten, Lars Christian Haugli |
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Bråten, Lars Christian Haugli ddc 610 bkl 44.00 misc Chronic low back pain misc Modic changes misc Antibiotic misc Effect modifier misc Subgroup misc Randomised misc Infection 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) |
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610 ASE 44.00 bkl 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) Chronic low back pain (dpeaa)DE-He213 Modic changes (dpeaa)DE-He213 Antibiotic (dpeaa)DE-He213 Effect modifier (dpeaa)DE-He213 Subgroup (dpeaa)DE-He213 Randomised (dpeaa)DE-He213 Infection (dpeaa)DE-He213 |
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ddc 610 bkl 44.00 misc Chronic low back pain misc Modic changes misc Antibiotic misc Effect modifier misc Subgroup misc Randomised misc Infection |
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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) |
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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 Petter Lutro, Olav Kristoffersen, Per Martin Anke, Audny Schistad, Elina Iordanova Skouen, Jan Sture Brox, Jens Ivar Zwart, John-Anker Storheim, Kjersti |
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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) |
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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) |
| abstract |
Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. |
| abstractGer |
Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. |
| abstract_unstemmed |
Background Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. Trial registration ClinicalTrials.gov NCT02323412, First registered 23 December 2014. |
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Grøvle, Lars Espeland, Ansgar Pripp, Are Hugo Grotle, Margreth Helllum, Christian Haugen, Anne Julsrud Froholdt, Anne Rolfsen, Mads Peder Nygaard, Øystein Petter Lutro, Olav Kristoffersen, Per Martin Anke, Audny Schistad, Elina Iordanova Skouen, Jan Sture Brox, Jens Ivar Zwart, John-Anker Storheim, Kjersti |
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Grøvle, Lars Espeland, Ansgar Pripp, Are Hugo Grotle, Margreth Helllum, Christian Haugen, Anne Julsrud Froholdt, Anne Rolfsen, Mads Peder Nygaard, Øystein Petter Lutro, Olav Kristoffersen, Per Martin Anke, Audny Schistad, Elina Iordanova Skouen, Jan Sture Brox, Jens Ivar Zwart, John-Anker Storheim, Kjersti |
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10.1186/s12891-020-03422-y |
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2024-07-03T15:15:22.090Z |
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A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. 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