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Confidential: for Review Only BMJ Confidential: For Review Only Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): a double- blind, randomised, placebo-controlled, multicentre trial Journal: BMJ Manuscript ID BMJ-2019-050262.R1 Article Type: Research BMJ Journal: BMJ Date Submitted by the 29-Jun-2019 Author: Complete List of Authors: Bråten, Lars Christian; Oslo University Hospital Ullevaal, FORMI; University of Oslo Faculty of Medicine Rolfsen, Mads Peder; Oslo University Hospital, Department of Orthopaedic surgery; University of Oslo Faculty of Medicine Espeland, Ansgar; Haukeland University Hospital, Department of Radiology; University of Bergen, Dep. of Clinical Medicine Wigemyr, Monica ; Oslo University Hospital Ullevaal, FORMI Assmus, Jörg; Haukeland University Hospital, Competence Center for Clinical Research Froholdt, Anne; Vestre Viken Hospital Trust, Dep. of Physical Medicine and Rehabilitation Haugen, Anne; Østfold Hospital Trust, Dep. of Rheumatology Marchand, Gunn Hege; Saint Olavs Hospital University Hospital in Trondheim, Dep. of Physical Health and Rehabilitation; Norwegian University of Science and Technology, Department of Neuromedicine and Movement Science Kristoffersen, Per Martin; Haukeland University Hospital, Department of Radiology; University of Bergen, Dep. of Clinical Medicine Lutro, Olav; Stavanger University Hospital Randen, Sigrun; Vestre Viken Hospital Trust, Dep. of Physical Medicine and Rehabilitation Wilhelmsen, Maja; University Hospital of North Norway, Dep. of rehabilitation; UiT Arctic University of Norway, Dep. of Clinical Medicine Winsvold, Bendik; Oslo University Hospital, Department of Research, Innovation and Education Kadar, Thomas; Haukeland University Hospital, Department of Physical Medicine and Rehabilitation Holmgard, Thor Einar; Norwegian Back Pain Association Vigeland, Maria; Oslo University Hospital Ullevaal, FORMI Vetti, Nils; Haukeland University Hospital, Department of Radiology; University of Bergen, Dep. of Clinical Medicine Nygaard, Øystein; Saint Olavs Hospital University Hospital in Trondheim, Department of Neuroscience; Norwegian University of Science and Technology, Department of Neuroscience Lie, Benedicte; Oslo University Hospital, Department of Immunology Hellum, Christian; Oslo University Hospital, Department of Orthopaedic https://mc.manuscriptcentral.com/bmj Page 1 of 101 BMJ 1 2 3 surgery 4 Anke, Audny; University Hospital of North Norway, Dep. of rehabilitation; 5 UiT Arctic University of Norway, Dep. of Clinical Medicine 6 Grotle, Margreth; Oslo Metropolitan University, Department of 7 physiotherapy; Oslo University Hospital Ullevaal, FORMI 8 Schistad, Elina; Oslo University Hospital, Department of Physical 9 Medicine and Rehabilitation Skouen, Jan; Haukeland University Hospital, Department of Physical 10 Confidential:Medicine and ForRehabilitation; Review University of Bergen, Only Department of Global 11 Public Health and Primary Care 12 Grøvle, Lars; Østfold Hospital Trust, Dep. of Rheumatology 13 Brox, Jens Ivar; Oslo University Hospital, Physical Medicine and 14 rehabilitation; University of Oslo Faculty of Medicine 15 Zwart, John-Anker; Oslo University Hospital, Department of Neurology 16 and FORMI; University of Oslo, Faculty of Medicine Storheim, Kjersti; FORMI, Clinic for Surgery and Neurology; Oslo 17 Metropolitan University, Department of physiotherapy 18 19 Keywords: back pain, Modic changes, antibiotic, randomised trial 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 2 of 101 1 2 3 1 Title page 4 5 6 2 7 8 9 3 Efficacy of antibiotic treatment in patients with chronic low back pain and Modic 10 4 changes (the AIM study): a double-blind, randomised, placebo-controlled, multicentre 11 5 trial 12 Confidential: For Review Only 6 13 7 Authors: 14 8 1. Lars Christian Haugli Bråten, MD (1.FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956, Nydalen, 0424, 15 9 Oslo, Norway. 2.University of Oslo, Faculty of Medicine, P.O. Box 1072 Blindern, 0316 Oslo, Norway). 16 10 [email protected] 11 2. Mads Peder Rolfsen, MD (1.Department of orthopaedic surgery, Oslo University Hospital, Postbox 4956, Nydalen, 0424, Oslo, 17 12 Norway. 2.University of Oslo, Faculty of Medicine, P.O. Box 1072 Blindern, 0316 Oslo, Norway). [email protected] 18 13 3. Ansgar Espeland, prof (1.Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021 Bergen, Norway. 2. 19 14 Department of Clinical Medicine, University of Bergen, P.O. Box 7804, 5020 Bergen, Norway). [email protected] 20 15 4. Monica Wigemyr, MSc (FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956, Nydalen, 0424, Oslo, 16 Norway). [email protected] 21 17 5. Jörg Aßmus, PhD (Centre for Clinical Research, Haukeland University Hospital, Jonas Liesvei 65, 5021 Bergen, Norway). 22 18 [email protected] 23 19 6. Anne Froholdt, PhD (Department of Physical Medicine and Rehabilitation, Drammen Hospital, Vestre Viken Hospital Trust 20 Drammen, P.O. Box 800, 3004 Drammen, Norway). [email protected] 24 21 7. Anne Julsrud Haugen, PhD (Department of Rheumatology, Østfold Hospital Trust, Grålum, Norway. Postal address: P.O. Box 25 22 300, 1714 Grålum, Norway). [email protected] 26 23 8. Gunn Hege Marchand, PhD (1.Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University 24 Hospital, P.O. Box 3250 Torgarden, NO-7006 Trondheim, Norway. 2. Department of Neuromedicine and Movement Science, 27 25 Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Norway). 28 26 [email protected] 29 27 9. Per Martin Kristoffersen, MD (1.Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021 Bergen, 28 Norway. 2. Department of Clinical Medicine, University of Bergen, P.O. Box 7804, 5020 Bergen, Norway). 30 29 [email protected] 31 30 10. Olav Lutro, MD (Stavanger University Hospital, Helse Stavanger HF, Postboks 8100, 4068 Stavanger, Norway). 32 31 [email protected] 33 32 11. Sigrun Randen, MD (Department of Physical Medicine and Rehabilitation, Drammen Hospital, Vestre Viken Hospital Trust 33 Drammen, P.O. Box 800, 3004 Drammen, Norway). [email protected] 34 34 12. Maja Wilhelmsen, PhD (1.Department of Rehabilitation, University Hospital of North Norway, P.O. Box 100, 9038 Tromsø, 35 35 Norway. 2.Faculty of Health Sciences, Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, 36 36 Norway). [email protected] 37 13. Bendik Slagsvold Winsvold, PhD (Department of Research, Innovation and Education, Division of Clinical Neuroscience, Oslo 37 38 University Hospital, P.O. Box 4956, Nydalen, 0424, Oslo, Norway). [email protected] 38 39 14. Thomas Istvan Kadar, PhD (Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen 39 40 HF, P.O. Box 1, 5021 Bergen, Norway). [email protected] 41 15. Thor Einar Holmgard, patient representative (Norwegian Back Pain Association, P.O. Box 9612 Fjellhagen, 3065 Drammen, 40 42 Norway). [email protected] 41 43 16. Maria Dehli Vigeland, MSc (1.FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956, Nydalen, 0424, Oslo, 42 44 Norway. 2.University of Oslo, Faculty of Medicine, P.O. Box 1072 Blindern, 0316 Oslo, Norway). [email protected] 43 45 17. Nils Vetti, PhD (1.Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021 Bergen, Norway. 2. 46 Department of Clinical Medicine, University of Bergen, P.O. Box 7804, 5020 Bergen, Norway). [email protected] 44 47 18. Øystein Petter Nygaard, PhD (1.Department of neurosurgery, St. Olavs University Hospital, P.O. Box 3250 Torgarden, NO-7006 45 48 Trondheim, Norway 2. Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, 46 49 Norway 3. National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim, Norway). [email protected] 50 19. Benedicte Alexandra Lie, prof (Department of Medical Genetics, University of Oslo and Oslo University Hospital, P.O. Box 47 51 4956, Nydalen, 0424, Oslo, Norway). [email protected] 48 52 20. Christian Hellum, PhD (Department of orthopaedic surgery, Oslo University Hospital, P.O. Box 4956, Nydalen, 0424, Oslo, 49 53 Norway). [email protected] 54 21. Audny Anke, prof (1.Department of Rehabilitation, University Hospital of North Norway, P.O. Box 100, 9038 Tromsø, Norway 50 55 2. Faculty of Health Sciences, Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway). 51 56 [email protected] 52 57 22. Margreth Grotle, prof (1.Oslo Metropolitan University, Department of physiotherapy, P.O. Box 4 St. Olavs plass, NO-0130 Oslo, 58 Norway 2. FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956, Nydalen, 0424, Oslo, Norway 3. Keele 53 59 University, Visiting Professor). [email protected] 54 60 23. Elina Iordanova Schistad, PhD (Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ulleval, P.O. 55 61 Box 4956, Nydalen, 0424, Oslo, Norway). [email protected] 56 62 24. Jan Sture Skouen, prof (1.Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, 63 Box 1, 5021 Bergen, Norway 2.University of Bergen, Department of Global Public Health and Primary Care, Kalfarveien 31, 57 64 5018 Bergen, Norway). [email protected] 58 65 25. Lars Grøvle, PhD (Department of Rheumatology, Østfold Hospital Trust, Grålum, Norway. Postal adress: P.O. Box 300, 1714 59 66 Grålum, Norway). [email protected] 60 1 https://mc.manuscriptcentral.com/bmj Page 3 of 101 BMJ 1 2 3 67 26. Jens Ivar Brox, prof (1.Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ulleval, P.O. Box 4 68 4956, Nydalen, 0424, Oslo, Norway 2.University of Oslo, Faculty of Medicine, P.O. Box 1072 Blindern, 0316 Oslo, Norway). 69 [email protected] 5 70 27. John-Anker Zwart, prof (1.FORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, P.O.
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