Engineering solutions to back pain: an interdisciplinary approach
Lead Research Organisation:
University of Leeds
Department Name: Mechanical Engineering
Abstract
At some point during our lifetimes, eight out of ten of us will experience low back pain. For some, a course of painkillers and a period of recovery will be enough to alleviate the symptoms, but this is not always the case and many people continue to suffer long term pain and discomfort. In joints such as the hip and knee, replacement surgery has become commonplace and is highly successful in reducing pain and restoring movement. In the spine however, corresponding treatments are still in their infancy and have yet to prove their long term effectiveness.It may seem farfetched to imagine that in less than two decades spinal treatments could develop to a level where back pain will be effectively treated using keyhole surgery and other minimally invasive techniques. However it is not beyond the realms of possibility if progress in the basic sciences along with developments in imaging and computer modelling continue. Perhaps most importantly, the understanding accrued in these many disciplines must be effectively harnessed and integrated. The aim of this research is to enable such a step change in spinal treatments to occur. Through the Exploration Funding, computer models of the spine will be developed in collaboration with experts from the basic sciences as well as clinicians and industrialists. These models will be used to investigate new implant materials and treatment techniques for back pain.The spine constantly undergoes complex biological, biochemical and mechanical processes which must be taken into account if new treatments are to be effective. Experimental tests will be used to assess these factors in isolation and the results combined into the computer models. There is much variation in the properties of the spinal structures both from one patient to another, and even along the length of an individual's back. These variations will also be simulated in the computer models to see how effective a treatment will be for a range of different patients. The computer models will enable new spinal treatments to be developed and optimised to bring maximum benefit to the patient before they are introduced into hospitals.By the end of the five year period of the Exploration Funding, a new and reliable method of testing spinal interventions will have been developed and research initiated to create a range of novel optimised treatments for back pain. In ten years time, this could lead to a new range of treatment options and, by 2020, effective minimally invasive treatment for back pain could become a reality.
Publications
Sikora Sebastien
(2013)
Experimental and computational study of the behaviour of trabecular bone-cement interfaces
Sikora SN
(2018)
Examination of an in vitro methodology to evaluate the biomechanical performance of nucleus augmentation in axial compression.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Song Y
(2014)
Unsupervised content classification based nonrigid registration of differently stained histology images.
in IEEE transactions on bio-medical engineering
Tarsuslugil SM
(2013)
Development of calcium phosphate cement for the augmentation of traumatically fractured porcine specimens using vertebroplasty.
in Journal of biomechanics
Tarsuslugil SM
(2014)
Experimental and computational approach investigating burst fracture augmentation using PMMA and calcium phosphate cements.
in Annals of biomedical engineering
V Wijayathunga
(2008)
FE models of human vertebra - effect of image-based material property assignment
V Wijayathunga
(2008)
Finite Element Analysis of Vertebrae Using Specimen-specific Methods: Review of Methods and Accuracy.
in Journal of Medical Biomechanics
V Wijayathunga
(2009)
Prophylactic Vertebroplasty: A Parametric Finite Element Study
Warren JP
(2023)
Controlling the Self-Assembly and Material Properties of ß-Sheet Peptide Hydrogels by Modulating Intermolecular Interactions.
in Gels (Basel, Switzerland)
| Description | The aim of this Challenging Engineering grant was to develop computer models of the spine to investigate new implant materials and treatment techniques for back pain. In parallel, two promising new treatments were identified (vertebroplasty and nucleus augmentation) and pilot studies undertaken to develop both the procedures themselves and the testing platforms necessary to optimise them before their introduction into patients. One of the reasons for the failure of previous spinal treatments is that there is much variation in the properties of the spinal structures from one patient to another, but pre-clinical testing is often undertaken under standardised conditions or on small numbers of specimens. As part of this grant, over 70 vertebrae were imaged using micro computed tomography (microCT - a 3D high resolution x-ray method) providing a major new database of information about the variation in vertebrae from one person to another. The vertebrae were then characterised in terms of their bone properties at different levels, from the level of the cells to the shape of the overall bone in both biological and mechanical terms. This information is being used to determine how the microscopic changes that occur in diseases such as osteoporosis can be related to clinical measurements, and will help clinicians identify which vertebrae are at risk of fracture. A new methodology was developed and validated for generating computational models, using finite element methods, from the image database of the vertebrae, allowing spinal treatments to be evaluated across a patient population rather than just on a single 'average' model. New methodologies were also developed to enable minimally invasive treatments for fractured vertebrae to be investigated in the laboratory and using computational models. This work focussed on 'vertebroplasty', a technique in which cement is injected into a fractured vertebra to stabilise the fracture and reduce pain. A novel method was developed that enabled specimens of cement-augmented bone to be microCT imaged under load, so that their behaviour could be more fully investigated, which led to a more robust methodology for simulating this technique in computational models. A workshop was also held (as part of Creativity@home funding) with the research team and leading clinicians to identify the scientific barriers to the more widespread introduction of vertebroplasty clinically. This work is now being taken forwards through a European Research Council (ERC) grant. A workshop was also held with leading clinicians and academics to identify the major challenges to successful treatment of disc degeneration, one of the leading causes of back pain. Following the workshop, research was focussed on a treatment to augment the nucleus of the disc, the central gel-like structure which becomes fibrous and loses height in disc degeneration. A new range of self-assembling peptides were characterised and optimised for use in nucleus augmentation. A patent has been submitted and this work is being taken forward through follow-on funding from the EPSRC. New methodologies for imaging and modelling the intervertebral discs were also developed. These include use of clinical magnetic resonance imaging (MRI) to identify the different components of the disc in both unloaded and loaded states, providing information on the mechanical behaviour of the tissue that is necessary for the design of new treatments. This work is being taken forward through follow-on funding from the ERC. In summary, through this funding new methodologies were developed to better understand and model the spine and spinal therapies. The modelling methods developed enable patient variation to be taken into account at an early stage of testing and are now being used to evaluate and optimise a range of treatments. Two new minimally invasive spinal interventions were also investigated and their development into clinical solutions is now being taken forward through follow-on funding. |
| Exploitation Route | A patent has been submitted for the peptides developed as part of this grant, and their development into a treatment is being taken forward through follow-on funding from the EPSRC (£1M, PI Wilcox, 'ULTRASPINE' grant ref EP/K020757/1 ) in collaboration with the University of Oxford. The database of microCT images of vertebrae has been used in collaboration with an industrial partner (Simpleware ltd, Exeter UK) to develop new code for generating finite element models that can represent patient variance. This work was developed though Proof of Concept funding provided by the Innovation and Knowledge Centre in Regenerative Therapies and Medical Devices at the University of Leeds, and will be developed further through European Research Council funding (EUR 1.5M, PI Wilcox, 'Back to Back' reference 306615). The computational methodologies developed in this grant have been adapted for the analysis of other orthopaedic applications. This includes a major grant from the British Orthopaedic Association in collaboration with a leading orthopaedic surgeon to investigate treatments for periprosthetic fracture (£400k, PI Tsiridis, 'Latta Fellowship'). In addition, the work has fed into two major grants (EPSRC Programme grant in Cartilage Biotribology (£4.5M, PI Fisher, ref EP/G012172/1) and the Wellcome/EPSRC Centre of Excellence in Medical Engineering (£11M, PI Fisher, 'WELMEC' ref 088908/Z/09Z) where the computational techniques developed are being used to evaluate a number of clinical interventions. |
| Sectors | Healthcare |
| Description | The major outcomes from this work were new methodologies for testing spinal interventions (experimental and computational) and the development of a novel peptide gel for nucleus augmentation, based on the design requirements derived from the mechanical testing, and informed by close liaison with clinicians (including targeted workshops that were held through the grant). A patent has been submitted for the peptides developed as part of this grant (now awarded in US, pending in EU), a commercialisation plan has been developed and industrial partners are currently being sought to develop this into a clinical product. This work is being further developed for other applications and taken forwards through PhD projects and further grant funding for an in vivo study. Using the data acquired in this study, a collaboration with an industrial partner (Simpleware ltd, Exeter UK) was initiated to develop new code for generating finite element models that can represent patient variance. This has been successfully completed and validated. The methods are currently being adapted for other joints, including through a Healthcare Impact Partnership grant with an orthopaedic manufacturer. |
| First Year Of Impact | 2012 |
| Sector | Digital/Communication/Information Technologies (including Software),Healthcare |
| Impact Types | Economic |
| Description | EPSRC Programme Grant |
| Amount | £4,536,888 (GBP) |
| Funding ID | EP/G012172/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 05/2009 |
| End | 06/2015 |
| Description | ERC Starting grant |
| Amount | € 1,500,000 (EUR) |
| Organisation | European Research Council (ERC) |
| Sector | Public |
| Country | Belgium |
| Start | 12/2012 |
| End | 11/2017 |
| Description | Healthcare Impact Partnership |
| Amount | £1,025,492 (GBP) |
| Funding ID | EP/N02480X/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 06/2016 |
| End | 05/2021 |
| Description | Healthcare Technologies Programme Grant |
| Amount | £3,962,447 (GBP) |
| Funding ID | EP/N02480X/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 10/2016 |
| End | 09/2021 |
| Description | ULTRASPINE: Ultrasound-Enabled Minimally Invasive Disc Replacement |
| Amount | £991,843 (GBP) |
| Funding ID | EP/K020757/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 04/2013 |
| End | 03/2018 |
| Description | Versus Arthritis Proof of Concept Grant 22031 |
| Amount | £100,000 (GBP) |
| Funding ID | 22031 |
| Organisation | Versus Arthritis |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 10/2018 |
| End | 10/2020 |
| Title | Data Associated with paper titled: Peptide:glycosaminoglycan hybrid hydrogels as an injectable intervention for spinal disc degeneration. |
| Description | Data Associated with paper titled: Peptide:glycosaminoglycan hybrid hydrogels as an injectable intervention for spinal disc degeneration. Data includes FTIR, TEM, optical micrographs, and processed numeric data used in the figures. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | Database has been made openly available. It has been used internally by other researchers in the group and university. External access has not yet been cited. |
| URL | https://doi.org/10.5518/47 |
| Title | Mengoni and Wilcox Ovine FSU data |
| Description | 8 cervical functional spinal units from 5 ovine spines: CT scan images, mechanical compression (load, displacement, pressure and image information) and FE models |
| Type Of Material | Database/Collection of data |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | Database released with paper to enable other researchers to access and compare data. Greater impact likely in future once data has been used. |
| URL | http://archive.researchdata.leeds.ac.uk/id/eprint/22 |
| Title | Ovine annulus fibrosus interlamellar material model calibration data set |
| Description | Experimental data: microscopy images and geometrical data of unloaded and radially loaded samples of ovine lumbar annulus fibrosus tissue; Computational data: input file and raw results of load/extension FE models built from the experimental data; Results data: values of calibrated interlamellar behaviour |
| Type Of Material | Database/Collection of data |
| Year Produced | 2015 |
| Provided To Others? | Yes |
| Impact | Data released to enable other researchers to apply or reuse for additional purposes. Great impact likely once data has been used and published. |
| URL | http://archive.researchdata.leeds.ac.uk/id/eprint/2 |
| Title | microCT vertebra database |
| Description | Database of over 50 high resolution scans of vertebrae made using microCT |
| Type Of Material | Database/Collection of data |
| Provided To Others? | No |
| Impact | follow-on funding obtained to use database to develop new modelling methods for spine to represent patient variation (EPSRC IKC proof of concept) and ERC Starting grant |
| Description | Simpleware Ltd |
| Organisation | Simpleware Ltd |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | Co-development of new software |
| Collaborator Contribution | Project partner of major grants providing expertise, access to new software features |
| Impact | Successful collaboration led to joint Proof of Concept study to develop new software funded through EPSRC IKC |
| Title | NOVEL PEPTIDE COMPLEXES |
| Description | The invention relates to novel self-assembling peptide complexes comprising a charged peptide and a polysaccharide, methods of producing them and uses therefor. The novel self-assembling peptide complexes of the present invention have particular utility in the restoration of biomechanical or biochemical function of a variety of biological tissues, for example and without limitation, in degenerated spinal discs, osteoarthritic joints, damaged cartilage, meniscus, ligaments, tendons, dental, ophthalmic and cardiovascular and blood vessel tissues. The invention provides inter alia methods of repairing and or restoring biomechanical or biochemical function of biological tissues and scaffolds for the support of cell growth. |
| IP Reference | WO2014167310 |
| Protection | Patent application published |
| Year Protection Granted | 2014 |
| Licensed | No |
| Impact | Follow-on funding obtained. Commercialisation workshop held as a demonstrator for JRI Ltd and used to map routes for future commercialisation/impact. Further applications being explored through PhD projects. |
| Title | NOVEL PEPTIDE COMPLEXES |
| Description | The invention relates to novel self-assembling peptide complexes comprising a charged peptide and a polysaccharide, methods of producing them and uses therefor. The novel self-assembling peptide complexes of the present invention have particular utility in the restoration of biomechanical or biochemical function of a variety of biological tissues, for example and without limitation, in degenerated spinal discs, osteoarthritic joints, damaged cartilage, meniscus, ligaments, tendons, dental, ophthalmic and cardiovascular and blood vessel tissues. The invention provides inter alia methods of repairing and or restoring biomechanical or biochemical function of biological tissues and scaffolds for the support of cell growth. |
| IP Reference | US2016058871 |
| Protection | Patent granted |
| Year Protection Granted | 2016 |
| Licensed | No |
| Impact | Follow on funding obtained for first in vivo study |
| Description | Creativity at home |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | Creativity@home funding used to train PDRAs in facilitation followed by an event to bring together leading clinicians from UK on topic of vertebroplasty to help inform our future research strategy. Outcomes from meeting include raised awareness of our research in clinical community, several potential future collaborators identified, and clinical opinion that has helped shape our future research activity in this area. |
| Year(s) Of Engagement Activity | 2013 |
| Description | Local engagement activities |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | Yes |
| Geographic Reach | Local |
| Primary Audience | Schools |
| Results and Impact | Stands always very popular with large numbers of delegates attending and requests to hold follow-on activities with schools and exhibit at future events. Extremely positive feedback from attendees, teachers and parents, leading to increasing requests to provide exhibits for other events |
| Year(s) Of Engagement Activity | 2009,2010,2011,2012,2013,2014 |
| Description | Royal Academy of Engineering Panel for Biomedical Engineering |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | Yes |
| Geographic Reach | National |
| Primary Audience | Participants in your research and patient groups |
| Results and Impact | Event promoted collaboration and career development for early-career medical engineers with advice from expert mentors and funders. Feedback from delegates very positive with 100% rating the networking opportunities and quality of the speakers and mentors as good or excellent. |
| Year(s) Of Engagement Activity | 2014 |
| URL | http://www.raeng.org.uk/publications/reports/young-researchers-futures-meeting-orthopaedic |
| Description | Science for a Successful Nation |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Presented stand depicting our research highlights to illustrate the importance of sustained funding as part of the EPSRC Science for a Successful Nation event |
| Year(s) Of Engagement Activity | 2015 |
| URL | https://www.epsrc.ac.uk/newsevents/news/sciencesuccessfulnation/ |