Advertisement

European Spine Journal

, Volume 28, Issue 11, pp 2478–2486 | Cite as

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

  • Ole K. Jensen
  • Morten H. Andersen
  • René D. Østgård
  • Niels T. Andersen
  • Nanna Rolving
Original Article

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.

Graphic abstract

Keywords

Modic changes Chronic low back pain Probiotics Lactic acid bacteria Inflammation Vertebral end-plate oedema 

Notes

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)

Compliance with ethical standards

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.

Supplementary material

586_2019_6046_MOESM1_ESM.pptx (150 kb)
Supplementary material 1 (PPTX 149 kb)

References

  1. 1.
    Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R (2014) The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 73(6):968–974CrossRefGoogle Scholar
  2. 2.
    Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED (2017) Nonpharmacologic therapies for low back pain: a systematic review for an American college of physicians clinical practice guideline. Ann Intern Med 166(7):493–505CrossRefGoogle Scholar
  3. 3.
    Chou R, Deyo R, Friedly J, Skelly A, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S (2017) Systemic pharmacologic therapies for low back pain: a systematic review for an American college of physicians clinical practice guideline. Ann Intern Med 166(7):480–492CrossRefGoogle Scholar
  4. 4.
    Waddell G (2004) The back pain revolution. Churchill Livingstone, EdinburghGoogle Scholar
  5. 5.
    Maatta JH, Wadge S, MacGregor A, Karppinen J, Williams FM (2015) ISSLS prize winner: vertebral endplate (Modic) change is an independent risk factor for episodes of severe and disabling low back pain. Spine (Phila Pa 1976) 40(15):1187–1193CrossRefGoogle Scholar
  6. 6.
    Brinjikji W, Diehn FE, Jarvik JG, Carr CM, Kallmes DF, Murad MH, Luetmer PH (2015) MRI findings of disc degeneration are more prevalent in adults with low back pain than in asymptomatic controls: a systematic review and meta-analysis. AJNR Am J Neuroradiol 36(12):2394–2399CrossRefGoogle Scholar
  7. 7.
    Rahme R, Moussa R (2008) The modic vertebral endplate and marrow changes: pathologic significance and relation to low back pain and segmental instability of the lumbar spine. AJNR Am J Neuroradiol 29(5):838–842CrossRefGoogle Scholar
  8. 8.
    Albert HB, Briggs AM, Kent P, Byrhagen A, Hansen C, Kjaergaard K (2011) The prevalence of MRI-defined spinal pathoanatomies and their association with modic changes in individuals seeking care for low back pain. Eur Spine J 20(8):1355–1362CrossRefGoogle Scholar
  9. 9.
    Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR (1988) Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology 166(1 Pt 1):193–199CrossRefGoogle Scholar
  10. 10.
    Ohtori S, Inoue G, Ito T, Koshi T, Ozawa T, Doya H, Saito T, Moriya H, Takahashi K (2006) Tumor necrosis factor-immunoreactive cells and PGP 9.5-immunoreactive nerve fibers in vertebral endplates of patients with discogenic low back Pain and Modic Type 1 or Type 2 changes on MRI. Spine (Phila Pa 1976) 31(9):1026–1031CrossRefGoogle Scholar
  11. 11.
    Dudli S, Fields AJ, Samartzis D, Karppinen J, Lotz JC (2016) Pathobiology of modic changes. Eur Spine J 25(11):3723–3734CrossRefGoogle Scholar
  12. 12.
    Albert HB, Sorensen JS, Christensen BS, Manniche C (2013) Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J 22(4):697–707CrossRefGoogle Scholar
  13. 13.
    Al-Falahi Mohanned A, Salal Mohammed H, Abdul-Wahab Dhiaa M (2014) Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (modic type i changes): a randomized clinical controlled trial of efficacy. Iraqui Postgrad Med J 13(3):390–397Google Scholar
  14. 14.
    Dudli S, Liebenberg E, Magnitsky S, Miller S, Demir-Deviren S, Lotz JC (2016) Propionibacterium acnes infected intervertebral discs cause vertebral bone marrow lesions consistent with Modic changes. J Orthop Res 34(8):1447–1455CrossRefGoogle Scholar
  15. 15.
    Dudli S, Liebenberg E, Magnitsky S, Lu B, Lauricella M, Lotz JC (2018) Modic type 1 change is an autoimmune response that requires a proinflammatory milieu provided by the ‘Modic disc’. Spine J 18(5):831–844CrossRefGoogle Scholar
  16. 16.
    Albert HB, Jensen AM, Dahl D, Rasmussen MN (2003) [Criteria validation of the Roland Morris questionnaire. A Danish translation of the international scale for the assessment of functional level in patients with low back pain and sciatica]. Ugeskr Laeger 165(18):1875–1880Google Scholar
  17. 17.
    Manniche C, Asmussen K, Lauritsen B, Vinterberg H, Kreiner S, Jordan A (1994) Low back pain rating scale: validation of a tool for assessment of low back pain. Pain 57(3):317–326CrossRefGoogle Scholar
  18. 18.
    Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC (2008) Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976) 33(1):90–94CrossRefGoogle Scholar
  19. 19.
    Stata Statistical Software (2005) Release 9. StataCorp LP, College StationGoogle Scholar
  20. 20.
    Jensen OK, Nielsen CV, Sorensen JS, Stengaard-Pedersen K (2014) Type 1 Modic changes was a significant risk factor for 1-year outcome in sick-listed low back pain patients: a nested cohort study using magnetic resonance imaging of the lumbar spine. Spine J 14(11):2568–2581CrossRefGoogle Scholar
  21. 21.
    Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Jensen TS, Manniche C (2012) Is the development of Modic changes associated with clinical symptoms? A 14-month cohort study with MRI. Eur Spine J 21(11):2271–2279CrossRefGoogle Scholar
  22. 22.
    Honda K, Littman DR (2016) The microbiota in adaptive immune homeostasis and disease. Nature 535(7610):75–84CrossRefGoogle Scholar
  23. 23.
    Jethwa H, Abraham S (2017) The evidence for microbiome manipulation in inflammatory arthritis. Rheumatology (Oxford) 56(9):1452–1460Google Scholar
  24. 24.
    Vaghef-Mehrabany E, Alipour B, Homayouni-Rad A, Sharif SK, Asghari-Jafarabadi M, Zavvari S (2014) Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis. Nutrition 30(4):430–435CrossRefGoogle Scholar
  25. 25.
    Cai G, Laslett LL, Aitken D, Halliday A, Pan F, Otahal P, Speden D, Winzenberg TM, Jones G (2018) Effect of zoledronic acid and denosumab in patients with low back pain and modic change: a proof-of-principle trial. J Bone Miner Res 33(5):773–782CrossRefGoogle Scholar
  26. 26.
    Jensen OK, Nielsen CV, Stengaard-Pedersen K (2010) One-year prognosis in sick-listed low back pain patients with and without radiculopathy. Prognostic factors influencing pain and disability. Spine J Aug;10(8):659–75CrossRefGoogle Scholar
  27. 27.
    Jensen OK, Stengaard-Pedersen K, Jensen C, Nielsen CV (2013) Prediction model for unsuccessful return to work after hospital-based intervention in low back pain patients. BMC Musculoskelet Disord 14(1):140CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Spine Center, Research Unit, University Research Clinic for Innovative Patient PathwaysSilkeborg Regional HospitalSilkeborgDenmark
  2. 2.University Research Clinic for Innovative Patient PathwaysSilkeborg Regional HospitalSilkeborgDenmark
  3. 3.Department of BiostatisticsUniversity of AarhusAarhusDenmark
  4. 4.DEFACTUMAarhusDenmark
  5. 5.RisskovDenmark

Personalised recommendations