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Probiotics for chronic low back pain with type 1 Modic changes: a randomized double-blind, placebo-controlled trial with 1-year follow-up using Lactobacillus Rhamnosis GG

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Abstract

Purpose

To investigate whether treatment by lactic acid bacteria for 100 days is associated with change of disability and pain in chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up.

Methods

Eighty-nine patients with CLBP and type 1 MC or mixed MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100 days.

Results

Missing values at 1 year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups. At 1 year, back pain had on average decreased by 1.1 more on a 0–10 scale (95% confidence interval 0.20–1.97) in the group treated by lactic acid bacteria than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at 1 year. Nine per cent of the patients reported gastrointestinal side effects without difference between groups.

Conclusions

No differences were found regarding the predefined outcomes. Overall, there was little improvement during the 1-year observation period. A small, though hardly clinically relevant, effect on back pain was seen after treatment by Lactobacillus Rhamnosis GG, and the treatment was without side effects in comparison with the control group.

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Acknowledgements

We would like to thank associated professor, Ph.D., Christian Lodberg Hvas, specialist of Gastroenterology, for fruitful discussions in regard to design of this study, although his recommendations of faecal sampling could not be followed. Furthermore, we would like to thank physiotherapist Anders Boes (†) and Secretary Maiken Madsen for their enthusiastic and thorough work ensuring relevant guidance and advice for the patients participating in this study.

Funding

The study has been supported by The Danish Rheumatism Association and Peter and Helga Korningsfond. This study was funded by Gigtforeningen (Grant No. R139-A3924)

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Authors and Affiliations

  1. Spine Center, Research Unit, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark

    Ole K. Jensen

  2. University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark

    Morten H. Andersen & René D. Østgård

  3. Department of Biostatistics, University of Aarhus, Aarhus, Denmark

    Niels T. Andersen

  4. DEFACTUM, Central Denmark Region, Aarhus, Denmark

    Nanna Rolving

  5. Risskov, Denmark

    Ole K. Jensen

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  1. Ole K. Jensen
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Conflict of interest

Ole Kudsk Jensen, Morten Hovgaard Andersen, René Drage Østgård, Niels Trolle Andersen and Nanna Rolving declare that they have no conflict of interest.

Ethical approval

Ethics approval was obtained from the institutional review board before commencement of this study. No benefits in any form have been or will be received from any commercial party related directly or indirectly to the subject of this manuscript.

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Jensen, O.K., Andersen, M.H., Østgård, R.D. et al. Probiotics for chronic low back pain with type 1 Modic changes: a randomized double-blind, placebo-controlled trial with 1-year follow-up using Lactobacillus Rhamnosis GG. Eur Spine J 28, 2478–2486 (2019). https://doi.org/10.1007/s00586-019-06046-6

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  • DOI: https://doi.org/10.1007/s00586-019-06046-6

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