Clinical trial NCT03100266 - References

Low Back Pain — Probiotics for Modic Changes in Low Back Pain Patients

Citation(s)

•   Albert HB, Briggs AM, Kent P, Byrhagen A, Hansen C, Kjaergaard K
  The prevalence of MRI-defined spinal pathoanatomies and their association with modic changes in individuals seeking care for low back pain. Eur Spine J. 2011 Aug;20(8):1355-62. doi: 10.1007/s00586-011-1794-6. Epub 2011 May 5.
•   Albert HB, Jensen AM, Dahl D, Rasmussen MN
  [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. 2003 Apr 28;165(18):1875-80. Danish.
•   Albert HB, Lambert P, Rollason J, Sorensen JS, Worthington T, Pedersen MB, Nørgaard HS, Vernallis A, Busch F, Manniche C, Elliott T
  Does nuclear tissue infected with bacteria following disc herniations lead to Modic changes in the adjacent vertebrae? Eur Spine J. 2013 Apr;22(4):690-6. doi: 10.1007/s00586-013-2674-z. Epub 2013 Feb 10.
•   Albert HB, Manniche C, Sorensen JS, Deleuran BW
  Antibiotic treatment in patients with low-back pain associated with Modic changes Type 1 (bone oedema): a pilot study. Br J Sports Med. 2008 Dec;42(12):969-73. doi: 10.1136/bjsm.2008.050369. Epub 2008 Aug 21.
•   Albert HB, Manniche C
  Modic changes following lumbar disc herniation. Eur Spine J. 2007 Jul;16(7):977-82. Epub 2007 Mar 3.
•   Albert HB, Sorensen JS, Christensen BS, Manniche C
  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. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13.
•   Bailly F, Maigne JY, Genevay S, Marty M, Gandjbakhch F, Rozenberg S, Foltz V
  Inflammatory pain pattern and pain with lumbar extension associated with Modic 1 changes on MRI: a prospective case-control study of 120 patients. Eur Spine J. 2014 Mar;23(3):493-7. doi: 10.1007/s00586-013-3036-6. Epub 2013 Sep 25.
•   Blondel B, Tropiano P, Gaudart J, Huang RC, Marnay T
  Clinical results of lumbar total disc arthroplasty in accordance with Modic signs, with a 2-year-minimum follow-up. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2309-15. doi: 10.1097/BRS.0b013e31820f7372.
•   Donato KA, Gareau MG, Wang YJ, Sherman PM
  Lactobacillus rhamnosus GG attenuates interferon-{gamma} and tumour necrosis factor-alpha-induced barrier dysfunction and pro-inflammatory signalling. Microbiology. 2010 Nov;156(Pt 11):3288-97. doi: 10.1099/mic.0.040139-0. Epub 2010 Jul 23.
•   Esposito P, Pinheiro-Franco JL, Froelich S, Maitrot D
  Predictive value of MRI vertebral end-plate signal changes (Modic) on outcome of surgically treated degenerative disc disease. Results of a cohort study including 60 patients. Neurochirurgie. 2006 Sep;52(4):315-22.
•   Hamamoto H, Miyamoto H, Doita M, Takada T, Nishida K, Kurosaka M
  Capability of nondegenerated and degenerated discs in producing inflammatory agents with or without macrophage interaction. Spine (Phila Pa 1976). 2012 Feb 1;37(3):161-7. doi: 10.1097/BRS.0b013e31821a874b.
•   Heffner KL, France CR, Trost Z, Ng HM, Pigeon WR
  Chronic low back pain, sleep disturbance, and interleukin-6. Clin J Pain. 2011 Jan;27(1):35-41.
•   Hjollund NH, Larsen FB, Andersen JH
  Register-based follow-up of social benefits and other transfer payments: accuracy and degree of completeness in a Danish interdepartmental administrative database compared with a population-based survey. Scand J Public Health. 2007;35(5):497-502.
•   Jensen OK, Nielsen CV, Sørensen JS, Stengaard-Pedersen K
  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. 2014 Nov 1;14(11):2568-81. doi: 10.1016/j.spinee.2014.02.018. Epub 2014 Feb 14.
•   Jensen OK, Nielsen CV, Stengaard-Pedersen K
  One-year prognosis in sick-listed low back pain patients with and without radiculopathy. Prognostic factors influencing pain and disability. Spine J. 2010 Aug;10(8):659-75. doi: 10.1016/j.spinee.2010.03.026. Epub 2010 May 5.
•   Jensen OK, Stengaard-Pedersen K, Jensen C, Nielsen CV
  Prediction model for unsuccessful return to work after hospital-based intervention in low back pain patients. BMC Musculoskelet Disord. 2013 Apr 19;14:140. doi: 10.1186/1471-2474-14-140.
•   Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Jensen TS, Manniche C
  Is the development of Modic changes associated with clinical symptoms? A 14-month cohort study with MRI. Eur Spine J. 2012 Nov;21(11):2271-9. doi: 10.1007/s00586-012-2309-9. Epub 2012 Apr 24.
•   Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Manniche C
  Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial. BMC Med. 2012 Feb 29;10:22. doi: 10.1186/1741-7015-10-22.
•   Jensen TS, Karppinen J, Sorensen JS, Niinimäki J, Leboeuf-Yde C
  Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J. 2008 Nov;17(11):1407-22. doi: 10.1007/s00586-008-0770-2. Epub 2008 Sep 12. Review.
•   Keller A, Boyle E, Skog TA, Cassidy JD, Bautz-Holter E
  Are Modic changes prognostic for recovery in a cohort of patients with non-specific low back pain? Eur Spine J. 2012 Mar;21(3):418-24. doi: 10.1007/s00586-011-1964-6. Epub 2011 Aug 12.
•   Kerttula L, Luoma K, Vehmas T, Grönblad M, Kääpä E
  Modic type I change may predict rapid progressive, deforming disc degeneration: a prospective 1-year follow-up study. Eur Spine J. 2012 Jun;21(6):1135-42. doi: 10.1007/s00586-012-2147-9. Epub 2012 Jan 17.
•   Kjaer P, Korsholm L, Bendix T, Sorensen JS, Leboeuf-Yde C
  Modic changes and their associations with clinical findings. Eur Spine J. 2006 Sep;15(9):1312-9. Epub 2006 Aug 9.
•   Kjaer P, Leboeuf-Yde C, Korsholm L, Sorensen JS, Bendix T
  Magnetic resonance imaging and low back pain in adults: a diagnostic imaging study of 40-year-old men and women. Spine (Phila Pa 1976). 2005 May 15;30(10):1173-80.
•   Kochan P, Chmielarczyk A, Szymaniak L, Brykczynski M, Galant K, Zych A, Pakosz K, Giedrys-Kalemba S, Lenouvel E, Heczko PB
  Lactobacillus rhamnosus administration causes sepsis in a cardiosurgical patient--is the time right to revise probiotic safety guidelines? Clin Microbiol Infect. 2011 Oct;17(10):1589-92. doi: 10.1111/j.1469-0691.2011.03614.x. Epub 2011 Aug 16.
•   Lopez M, Li N, Kataria J, Russell M, Neu J
  Live and ultraviolet-inactivated Lactobacillus rhamnosus GG decrease flagellin-induced interleukin-8 production in Caco-2 cells. J Nutr. 2008 Nov;138(11):2264-8. doi: 10.3945/jn.108.093658.
•   Manniche C, Asmussen K, Lauritsen B, Vinterberg H, Kreiner S, Jordan A
  Low Back Pain Rating scale: validation of a tool for assessment of low back pain. Pain. 1994 Jun;57(3):317-26.
•   Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR
  Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988 Jan;166(1 Pt 1):193-9.
•   Muñoz-Cánoves P, Scheele C, Pedersen BK, Serrano AL
  Interleukin-6 myokine signaling in skeletal muscle: a double-edged sword? FEBS J. 2013 Sep;280(17):4131-48. doi: 10.1111/febs.12338. Epub 2013 Jun 18. Review.
•   Pessi T, Sütas Y, Hurme M, Isolauri E
  Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8.
•   Rahme R, Moussa R
  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. 2008 May;29(5):838-42. doi: 10.3174/ajnr.A0925. Epub 2008 Feb 13. Review.
•   Schultz M, Linde HJ, Lehn N, Zimmermann K, Grossmann J, Falk W, Schölmerich J
  Immunomodulatory consequences of oral administration of Lactobacillus rhamnosus strain GG in healthy volunteers. J Dairy Res. 2003 May;70(2):165-73.
•   Solgaard Sorensen J, Kjaer P, Jensen ST, Andersen P
  Low-field magnetic resonance imaging of the lumbar spine: reliability of qualitative evaluation of disc and muscle parameters. Acta Radiol. 2006 Nov;47(9):947-53.
•   Steffens D, Hancock MJ, Maher CG, Williams C, Jensen TS, Latimer J
  Does magnetic resonance imaging predict future low back pain? A systematic review. Eur J Pain. 2014 Jul;18(6):755-65. doi: 10.1002/j.1532-2149.2013.00427.x. Epub 2013 Nov 26. Review.
•   Studer RK, Vo N, Sowa G, Ondeck C, Kang J
  Human nucleus pulposus cells react to IL-6: independent actions and amplification of response to IL-1 and TNF-a. Spine (Phila Pa 1976). 2011 Apr 15;36(8):593-9. doi: 10.1097/BRS.0b013e3181da38d5.
•   Wedderkopp N, Thomsen K, Manniche C, Kolmos HJ, Secher Jensen T, Leboeuf Yde C
  No evidence for presence of bacteria in modic type I changes. Acta Radiol. 2009 Jan;50(1):65-70. doi: 10.1080/02841850802524485.
•   Zein EF, Karaa S, Chemaly A, Saidi I, Daou-Chahine W, Rohban R
  [Lactobacillus rhamnosus septicemia in a diabetic patient associated with probiotic use: a case report]. Ann Biol Clin (Paris). 2008 Mar-Apr;66(2):195-8. doi: 10.1684/abc.2008.0210. French.
•   Zhang L, Li N, Caicedo R, Neu J
  Alive and dead Lactobacillus rhamnosus GG decrease tumor necrosis factor-alpha-induced interleukin-8 production in Caco-2 cells. J Nutr. 2005 Jul;135(7):1752-6.

Probiotics for Modic Changes: a Randomised Controlled Study to Elucidate the Effect of Probiotics on Vertebral Inflammatory End-plate Changes, So-called Type 1 Modic Changes

Details for clinical trial NCT03100266