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The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial (LIFEHAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT06169488

Recruitment Status : Recruiting

First Posted : December 13, 2023

Last Update Posted : May 1, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

University Hospital, Akershus

Haukeland University Hospital

Vestre Viken Hospital Trust

St. Olavs Hospital

Unicare

Information provided by (Responsible Party):

Kjersti Storheim, Oslo University Hospital

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	October 2030
Estimated Study Completion Date :	December 2030

Publications:

GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.

Montgomery MW, Yawetz S, Levy BD, Loscalzo J. Back to the History. N Engl J Med. 2017 May 4;376(18):1783-1788. doi: 10.1056/NEJMcps1607608. No abstract available.

Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

Bez M, Zhou Z, Sheyn D, Tawackoli W, Giaconi JC, Shapiro G, Ben David S, Gazit Z, Pelled G, Li D, Gazit D. Molecular pain markers correlate with pH-sensitive MRI signal in a pig model of disc degeneration. Sci Rep. 2018 Nov 26;8(1):17363. doi: 10.1038/s41598-018-34582-6.

Hancock MJ, Maher CG, Laslett M, Hay E, Koes B. Discussion paper: what happened to the 'bio' in the bio-psycho-social model of low back pain? Eur Spine J. 2011 Dec;20(12):2105-10. doi: 10.1007/s00586-011-1886-3. Epub 2011 Jun 25.

Albert HB, Kjaer P, Jensen TS, Sorensen JS, Bendix T, Manniche C. Modic changes, possible causes and relation to low back pain. Med Hypotheses. 2008;70(2):361-8. doi: 10.1016/j.mehy.2007.05.014. Epub 2007 Jul 10.

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.

Braten LCH, Rolfsen MP, Espeland A, Wigemyr M, Assmus J, Froholdt A, Haugen AJ, Marchand GH, Kristoffersen PM, Lutro O, Randen S, Wilhelmsen M, Winsvold BS, Kadar TI, Holmgard TE, Vigeland MD, Vetti N, Nygaard OP, Lie BA, Hellum C, Anke A, Grotle M, Schistad EI, Skouen JS, Grovle L, Brox JI, Zwart JA, Storheim K; AIM study group. Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial. BMJ. 2019 Oct 16;367:l5654. doi: 10.1136/bmj.l5654. Erratum In: BMJ. 2020 Feb 11;368:m546.

Gilbert HTJ, Hodson N, Baird P, Richardson SM, Hoyland JA. Acidic pH promotes intervertebral disc degeneration: Acid-sensing ion channel -3 as a potential therapeutic target. Sci Rep. 2016 Nov 17;6:37360. doi: 10.1038/srep37360.

Weber KT, Alipui DO, Sison CP, Bloom O, Quraishi S, Overby MC, Levine M, Chahine NO. Serum levels of the proinflammatory cytokine interleukin-6 vary based on diagnoses in individuals with lumbar intervertebral disc diseases. Arthritis Res Ther. 2016 Jan 7;18:3. doi: 10.1186/s13075-015-0887-8.

Deng X, Zhao F, Kang B, Zhang X. Elevated interleukin-6 expression levels are associated with intervertebral disc degeneration. Exp Ther Med. 2016 Apr;11(4):1425-1432. doi: 10.3892/etm.2016.3079. Epub 2016 Feb 16.

Hiyama A, Suyama K, Sakai D, Tanaka M, Watanabe M. Correlational analysis of chemokine and inflammatory cytokine expression in the intervertebral disc and blood in patients with lumbar disc disease. J Orthop Res. 2022 May;40(5):1213-1222. doi: 10.1002/jor.25136. Epub 2021 Jul 11.

Gornet MG, Peacock J, Claude J, Schranck FW, Copay AG, Eastlack RK, Benz R, Olshen A, Lotz JC. Magnetic resonance spectroscopy (MRS) can identify painful lumbar discs and may facilitate improved clinical outcomes of lumbar surgeries for discogenic pain. Eur Spine J. 2019 Apr;28(4):674-687. doi: 10.1007/s00586-018-05873-3. Epub 2019 Jan 4.

Brox JI, Nygaard OP, Holm I, Keller A, Ingebrigtsen T, Reikeras O. Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain. Ann Rheum Dis. 2010 Sep;69(9):1643-8. doi: 10.1136/ard.2009.108902. Epub 2009 Jul 26.

Brox JI, Reikeras O, Nygaard O, Sorensen R, Indahl A, Holm I, Keller A, Ingebrigtsen T, Grundnes O, Lange JE, Friis A. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study. Pain. 2006 May;122(1-2):145-55. doi: 10.1016/j.pain.2006.01.027. Epub 2006 Mar 20.

Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21. doi: 10.1097/01.BRS.0000083234.62751.7A.

Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.

Fairbank J, Frost H, Wilson-MacDonald J, Yu LM, Barker K, Collins R; Spine Stabilisation Trial Group. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ. 2005 May 28;330(7502):1233. doi: 10.1136/bmj.38441.620417.8F. Epub 2005 May 23. Erratum In: BMJ. 2005 Jun 25;330(7506):1485.