Project - Global Alliance for Musculoskeletal Health



|Main project |The Low Back Pain Study |

|Sub project | |

|Project leader | |

| |John Anker Zwart |

|Project group | |

| |The Bone and Joint Research Group, Treliske |

|Project type |( iProject – internal |( aProject – associated |( cProject – collaborative |

|Collaborating partners |1. (Coordinator) |

| |Prof. John-Anker Zwart Institute of Clinical Medicine, University of Oslo |

| |2. Prof. Jan Hartvigsen, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark |

| |3. Ass.prof Eva Kosek Department of Clinical Neuroscience, Karolinska Institute, Stockholm |

| |4. Prof. Aarno Palotie Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Helsinki, Finland |

| |and the Broad Institute of MIT and Harvard, Boston, USA |

| |5. Prof. Ansgar Espeland Department of Radiology, Haukeland University Hospital and Department of Clinical |

| |Medicine, University of Bergen |

| |6. Prof. George Peat Research Institute for Primary Care & Health Sciences, Keele University |

| |7. Prof. Thomas Tolle Department of Neurology, Technische Universitaet Muenchen |

| |8. Prof. Anthony Woolf The Global Alliance for Musculoskeletal Health and European Musculoskeletal Information and|

| |Surveillance Network |

| |9. Prof. Benedicte Lie Department of Medical Genetics, Oslo University Hospital |

|Timeline |Expected start (2015-07) |Estimated completion (2018-12) |

PROJECT DESCRIPTION (Max 1 page, full details in project plan)

|Project – Aim (150 words) |

| |

|The main objective of the current proposal is to uncover the underlying pathophysiological mechanisms and determine how these interact with psychological |

|and social factors in causing recurrent and chronic LBP in order to improve preventive, diagnostic, therapeutic and preventive strategies. This objective |

|will be addressed in eight work packages (WP), including project management (WP1), aimed at identifying novel biomarkers and disease mechanisms by |

|combining genetic, molecular, imaging, environmental and clinical information in our unique cohorts. |

|We aim to coordinate and facilitate collaboration between top research institutions with an outstanding record in pain and low-back pain research |

|We aim to create an accessible inventory for LBP researchers worldwide of LBP phenotype data currently held within large European birth cohorts, population|

|cohorts and biobanks, as well as clinical registries and cohorts. |

|We aim to assess, identify and validate determinants for LBP across the lifespan, identify and validate candidate physical, psychosocial and lifestyle |

|exposures with strong main effects on LBP at different life stages and explore the effect of cumulative exposures on the occurrence and persistence of LBP |

|and develop a prediction model based on prior cumulative exposure rather than current status. |

|We aim to assess the “biological spinal age” in LBP patients based on structural degenerative findings on MRI that are combined with systematically |

|collected clinical information and develop clinical prediction models based on MRI phenotypes. |

|We aim to improve and develop new MRI assessment protocols of lumbar degenerative disc changes (like Modic Changes (MCs)), so that patients can be |

|classified more consistently according to the underlying lesions and evaluate the predictive value of rapidly progressing MRI findings in adolescents in |

|relation to development of LBP. |

|We aim to identify and characterize biomarkers for chronic LBP and lumbar disc degeneration (MCs) by assessing changes in systemic gene expression, |

|identify cell-types and pathways involved, presence of infectious agents and whether a low-grade inflammation is reflected by an altered gene or protein |

|expression of inflammatory biomarkers and reversed by successful treatment. |

|We aim to unravel nociceptive and neurobiological mechanisms modulating LBP and chronification by deciphering the interaction between relevant genetic |

|variants/polymorphisms and effects on; a) altered brain activation patterns, b) pain sensitivity and modulation, and c) assess the predictive value of |

|neurophysiological testing in a clinical setting |

|We aim to assess whether: a) patients with acute temporary, recurrent and chronic LBP have different genetic susceptibility spectra, b) assess whether |

|genetic profiles and functional polymorphisms can predict treatment response and affect pain modulation, and c) assess the interaction between |

|environmental and genetics susceptibility profiles |

|We aim to widely disseminate across biomedical researchers, physicians, allied health professions, health workers, patients, patient organizations, the |

|general public, and health care decision makers, the new knowledge generated by this study on: a) how LBP best should be diagnosed by using a diagnostic |

|tool set and biomarkers; b) how pain is generated and how this process can be blocked, alleviating the pain; c) how chronification of LBP may begin and |

|progress, and d) how these results should be implemented in targeted treatment and preventive programs. |

|Objectives for Work Package 8 - Dissemination |

|To inform the scientific community on scientific results from the Low-Back Pain project |

|To share results from separate working packages with the overall consortium to improve coherence of the total project |

|To inform relevant stakeholders (e.g. scientists, clinicians, patients and European policy makers) about the scientific value of the Low-Back Pain project |

|To provide public access to all non-confidential information of the project |

|To facilitate the use and implementation of the results in European health care practice |

|To protect actively all newly generated knowledge with economic potential |

|To ensure sure that all research in the Low-Back Pain Study will respect and involve gender innovation aspects |

| |

| |

|Project - Background (300 words) |

|Understanding health, ageing and disease: determinants, risk factors and pathways, and will focus on Low-Back-Pain. |

|The main objective of the current proposal is to uncover the underlying biological mechanisms and the combined effects of factors causing recurrent and |

|chronic LBP in order to improve diagnostic, therapeutic and preventive strategies. This will be achieved by combining genetic, molecular, imaging, |

|environmental and clinical information from existing and ongoing cohorts. |

| |

|Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age groups from adolescents to elderly and has increased from 58 |

|million years lived with disability (YLDs) in 1990 to 83 million YLDs in 2010 [pic]1. The burden is accordingly substantially higher than previously |

|assessed, in particular within the EU, causing activity limitation and work absence with subsequently enormous economic burden on individuals, families, |

|communities, industry, health services and governments. |

| |

|About 70 – 85 % of the population experience LBP during adult life. Clinical guidelines suggest that recovery from an episode of recent onset LBP is |

|usually rapid and complete, but recent high-quality studies report that recovery is much slower and many do not recover within a year [pic]2,3. There is |

|good evidence to suggest that psychological constructs are significant predictors of outcomes such as more severe pain, greater functional disability, and |

|work loss, and these constructs also play a role in the transition from acute to persistent pain and disability [pic]4. On the other hand, biological |

|findings like degenerative disc changes on magnetic resonance imaging (MRI) are present in more than two thirds of patients with chronic LBP (CLBP). There |

|is, however, no reliable means for its diagnosis or treatment and the underlying biological mechanism for the transition from an acute to a chronic pain |

|state is not known 5. |

| |

|Despite considerable research efforts, LBP remains a poorly understood condition. The “biopsychosocial model” of LBP has been the standard approach over |

|the last decades [pic]6 and clinical guidelines promote an approach where 85-90% of patients do not receive a patho-anatomical diagnosis. The clinicians |

|are accordingly left with a trial and error approach and are often unable to predict which patients will respond to which treatment. Since a patho-anatomic|

|diagnosis is not pursued, clinicians apply generic symptomatic treatments such as advice to stay active and avoid bed-rest, analgesic medications, |

|reassurance and exercises. Systematic reviews reveal that existing treatments have, at best, only small effects [pic]7. Understanding the underlying |

|principles of a condition is a prerequisite for designing effective interventions and preventing strategies. The biopsychosocial model has increased our |

|knowledge of the complexity of LBP, but there is a strong need for a better understanding, in particular of the underlying biological factors, in order to |

|improve diagnostic and therapeutic strategies as well as generate evidence based preventive measures. |

| |

|It is generally recognized that the etiology of LBP is multifactorial with a complex pathogenesis. It is well known that LBP is associated with several |

|negative determinants of health and that there are individual differences in pain perception, but too little is known about the interaction between |

|environmental, biological and genetic factors. The absence of a good understanding of the underlying biological causes for why LBP becomes chronic has |

|hampered the development of effective prevention and treatment. |

| |

|In acknowledgement of the huge burden and impact of musculoskeletal disorders in Norway as well as globally, the National Co-operation Group on Health |

|Research (NSG) endorsed in 2012 a national effort to focus on research within the field of musculoskeletal disease (muss.no), and The European |

|Parliament has recently signalled that research on rheumatic and musculoskeletal conditions shall be among the areas prioritized within the EU Research |

|Framework Programme for 2014 to 2020 (Horizon 2020). |

| |

|Project – Plan (400 words (target audience, population, methods , feasibility etc) |

| |

|Description of work (where appropriate, broken down into tasks), lead partner and role of participants |

|The Low-Back Pain consortium will ensure optimal dissemination and exploitation of knowledge to stakeholders. |

|Six tasks with associated sub-tasks have been identified: |

| |

|Task 8.1 Set up a Low Back Pain website (Deliverable 8.1 - Delivery of The Low-Back Pain project website (MO 6) |

|1. The WP8 lead produce an initial design for a Low-Back-Pain website that will be partly open to the general public with an intranet-restricted part |

|designated for internal communication between participants and external communication to the EU. The WP8 lead will agree the initial design with the WP1 |

|lead. |

|2. The WP8 lead and the WP1 lead will agree and identify the appropriate resources that are qualified to build and deliver the Low-Back-Pain website. |

|3. The WP8 lead and the WP1 lead will provide the identified resources with the required design to develop and deliver the Low-Back-Pain website. |

|4. The WP8 lead will maintain the content of the website in line with the Dissemination Plan throughout the life of the Low-Back Pain project. The Low-Back|

|Pain website will be accessible by links from other websites, including those of the member organisations of the consortium and those of the Global |

|Alliance for Musculoskeletal Health – the Bone and Joint Decade. |

|5. Beyond the project end, the website will continue to be accessible from the linked sites to sustain dissemination of the results. |

| |

|Task 8.2 Identify the Stakeholder Map (Deliverable 8.2 – Stakeholder Map (MO 3) |

|1. The WP8 lead will contact the member organisations of the consortium who will be responsible for providing stakeholder details based on specified |

|criteria. |

|2. The WP8 lead will combine the lists received and will draw up one list – the draft Stakeholder map. The list will be circulated among all the member |

|organisations of the consortium to reach consensus. |

|3. The stakeholder map will be placed on the LBP web site in the area confidential to members of the consortium, and will be regularly updated by the WP8 |

|lead during the life span of the study. |

| |

|Task 8.3 Prepare and Publish Newsletter (Deliverable 8.3 - Regular newsletters (every 6 Mo) |

|1. The WP8 lead will collate information about the achievements of the study, including reports, published articles and press releases, presentations and |

|media appearances by its members and will also collate details of relevant events scheduled throughout the life of the LBP study. |

|2. The WP8 lead will prepare and publish an internal newsletter every 6 months. The newsletter will be circulated among all the member organisations of the|

|consortium. |

|3. The WP8 lead will prepare and publish interim newsflash items on the LBP website to keep members of the consortium informed of progress and |

|dissemination achievements. |

| |

|Task 8.4 Maintain schedule of Scientific Meetings (Deliverable 8.4 – Schedule of Scientific Meetings (every 3 Mo) |

|1. The WP8 lead will contact the member organisations of the consortium and ask for details of scientific meetings / conferences relevant to dissemination |

|of the LBP results. |

|2. The WP8 lead will collate the information received and draw up a schedule of events. The schedule of events will be circulated among all the member |

|organisations of the consortium to reach consensus. |

|3. The WP8 lead will contact the organisers of scientific meetings and get details of the criteria and timescales for preparing and presenting abstracts |

|and posters and for being invited to present. |

|4. The schedule of Scientific Meetings and criteria and timescales will be placed on the project web site and will be regularly updated by the WP8 lead |

|during the life span of the study. |

| |

|Task 8.5 Dissemination of Scientific Articles and Press Releases; record of achievements (Deliverable 8.5 - List of all published Low-Back Pain scientific |

|papers and press coverage (MO 36) |

|1. Each of the member organisations of the consortium will prepare papers of the outcomes of the study for publication in scientific journals as required |

|by the WP1 Lead. |

|2. The WP8 Lead will be informed of publication plans and will collate finalised papers. |

|3. The WP8 lead will disseminate the papers to other members of the consortium and to external stakeholders as agreed by the WP1 Lead. |

|4. Each of the member organisations of the consortium will inform the WP8 lead of opportunities for press releases and the open access media that is being |

|targeted. |

|5. The WP8 lead will prepare and distribute press releases for review and consensus approval by the member organisations of the consortium. |

|6. The WP8 lead will distribute the agreed press release to the open access journals, as identified. |

|7. The WP8 Lead maintain a record of dissemination achievements that will include the presentations, posters, media appearances and other dissemination |

|achievements of the Low-Back-Pain study, as advised by each of the member organisations of the consortium. |

|8. The WP8 lead will publish the record in the six monthly newsletter and on the LBP website. |

| |

|Task 8.6 Prepare Dissemination Plan (Deliverable 8.6 – Dissemination plan (MO 36) |

|1. The WP8 lead will draft a dissemination plan in conjunction with the WP1 lead which will include: the overall dissemination strategy, the map of the |

|stakeholders, the criteria for research to respect and involve gender innovation aspects, the terms of reference for an IPR task force that guarantees that|

|Low-Back Pain data is adequately protected. |

|2. The WP8 lead will circulate the draft dissemination plan among all the WP leads for agreement and will subsequently present the dissemination plan at |

|each of the LBP study periodic progress meetings for review and update by the member organisations of the consortium. |

|3. The WP8 lead will keep the Dissemination Plan up to date and will include in the final version the plans for sustaining the results of the Low-Back Pain|

|project beyond the project end in Month 36. |

| |

|Project – Expected outcome (300 words) |

| |

|Deliverables (brief description and month of delivery) |

|Milestone number |

|Milestone name |

|Related work package(s) |

|Estimated date (month) |

|Means of verification |

| |

|M8-1.1 |

|Website design document |

|WP8 |

|4 |

|Document |

| |

|M8-1.2 |

|Website delivery |

|WP8 |

|6 |

|Website accessible |

| |

|M8-2 |

|1st version of Stakeholder map |

|WP8 |

|3 |

|Document |

| |

|M8-3 |

|1st Newsletter Published |

|WP8 |

|6 |

|Newsletter published |

| |

|M8-4 |

|1st Schedule of Scientific Meetings  |

| WP8 |

| 3 |

|Events Calendar published  |

| |

|M8-5 |

|1st Record of Dissemination Achievements  |

|WP8  |

|6  |

|In Newsletter and website  |

| |

|M8-6.1 |

|1st Dissemination Plan  |

|WP8  |

| 6 |

|Document  |

| |

|M8-6.2 |

|Final dissemination and exploitation plans |

|WP8 |

|36 |

|Report |

| |

| |

| |

|Project – Resources needed (100 word (estimate of costs –details in budget sheet)) |

| |

|Professor Anthony Woolf will be the project lead. Professor Woolf is a Consultant Rheumatologist and Honorary Professor of Rheumatology, University of |

|Exeter Medical School, and Plymouth Peninsula Medical and Dental College. He has been involved throughout his career in various initiatives to promote |

|priority for the various musculoskeletal conditions and to improve their management by raising awareness of their impact, promoting education and research,|

|and setting standards for prevention and treatment. This has been by working together with all professions, disciplines and patient organisations at a |

|national, European and international level. He has held executive roles in National Osteoprosis Society 1987-2002 (including treasurer and chair); |

|BLAR/ARMA 1994-2005 (including leading regional groups); EULAR1994-2007 (including chair of education committee and international liaison officer); |

|president UEMS 2001-06; Bone and Joint Decade 1998 – now (including treasurer and chair). He has also led 2 EU projects to raise standards of care – |

|European Bone and Joint Strategies Project and European Musculoskeletal Surveillance and Information network. In these roles he worked with the Department|

|of Health, the EU, WHO Europe and WHO International. Professor Woolf edits the serial Best Practice and Research Clinical Rheumatology which provides an |

|evidence-based update on the management of musculoskeletal conditions. In addition he is Clinical Director of the NHS National Institute of Health |

|Research Clinical Research Network Southwest Peninsula. Through this people wherever they live in the region can participate in clinical research so they |

|have the option of the latest and innovative treatments. A culture of research and innovation also improves the overall quality of care. A copy of |

|Professor Woolfs cv is attached. |

|Jim Howarth will provide Dissemination and Project Management to Work Package 8. He has been responsible for the management of the project and |

|in particular the management of the dissemination work package (see above). He is also responsible for the business management activities of the Bone and |

|Joint Decade including management of dissemination activities (see above). |

|Katie Edwards will provide dissemination expertise to Work Package 8. She was previously responsible for delivering significant elements of the |

|dissemination activities of including the role of web editor and coordination of reporting and news gathering from the partners. She |

|is currently responsible for web editorship for the Bone and Joint Decade and for a local charity – Cornwall Arthritis Trust, she also manages the social |

|media activities of the Bone and Joint Decade and is responsible for editing and publishing the periodic newsletter of the Bone and Joint Decade. |

| |

|Participant Number/Short Name |

|Cost (€) |

|Justification |

| |

|8. GA |

| |

| |

| |

|Travel |

|16 000 |

|Steering committee meetings |

| |

|Equipment |

|  |

|  |

| |

|Other goods and services |

|6 634 |

|Data acquisition , costs open access publications, printed materials |

| |

|Other goods and services |

|50 000 |

|Website build |

| |

|Total |

|72 634 |

| |

| |

| |

| Potential funding sources (100 words) |

| |

| |

|European Union via Work program topic: PHC 1 – 2014: Understanding health, ageing and disease: determinants, risk factors and pathways |

|Appendix 1) Project plan (4 pages), 2) Budget (1 page), 3) Business plan |

|Work package submitted by: |Date |

|Jim Howarth / Anthony Woolf |05/08/2014 |

|How the Project was Acquired |

| |

|In November 2013 AW addressed a research conference in Norway as a result of which contacts were established with those developing the Lower Back |

|Pain project. In July 2014 a formal invitation to join the consortium was received from the EU. |

|. |

|How the Project is Progressing |

| |

|A work package proposal to deliver the Dissemination element of the LBP was develop in July 2014 and submitted to the consortium. The final |

|submission for the LBP was presented to the EU by the consortium in mid-August 2014. |

| |

|The proposal is being considered by the EU. |

| |

|(Updated 10th November 2014) |

| |

|Which resources will be involved |

| |

|The resources named in the proposal are Anthony Woolf, Jim Howarth and Katie Edwards of the RCHT Bone and Joint Research Group, Treliske. |

BUDGET SHEET

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PROJECT COST

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|Budget submitted by: |Date |

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