Download Project - Global Alliance for Musculoskeletal Health

BJD Work package
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
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
Expected start (2015-07)
Estimated completion (2018-12)
Collaborating
partners
Timeline
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 lowback 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
BJD Work package
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
1.
2.
3.
To inform the scientific community on scientific results from the Low-Back Pain project
4.
5.
6.
7.
To provide public access to all non-confidential information of the 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 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 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 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
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 6 and clinical guidelines promote an approach where 85-90% of patients do not receive a pathoanatomical 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 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
(www.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 intranetrestricted 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-BackPain website.
BJD Work package
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
M8-1.1
Website design document
Related work
package(s)
Estimated date
(month)
Means of verification
WP8
4
Document
BJD Work package
M8-1.2
WP8
6
Website accessible
Website delivery
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
WP8
36
Report
M8-6.2
Final dissemination and exploitation plans
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
eumusc.net 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 eumusc.net including the role of web editor and coordination of reporting and news gathering from the
eumusc.net 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
16 000
Steering committee meetings
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
8. GA
Travel
Equipment
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
BJD Work package
Work package submitted by:
Jim Howarth / Anthony Woolf
Date
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.
BJD Work package
BUDGET SHEET
Main project
PROJECT XXXXX
Sub project
Project leader
Project group
Collaborating
partners
Timeline
Expected start (yyyy-mm)
Estimated completion (yyyy-mm)
PROJECT COST
Persons / staff
Communication
Travels
Total Amount
(name if available)
Budget submitted by:
Date