13 December 2011

A patient-specific predictive platform to treat back pathologies

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Back pain is a major health and socio-economic issue throughout Europe. Research has shown that 80% of the active population suffers from low back pain at some point in their lives while treating the disorder costs the EU 7000 € per inhabitant each year. Low back pain is also one of the major causes of long-term absences from work

Despite being such a common problem, the decision-making process regarding the treatment of lumbar or low back pain is slow and it is hard for clinicians to decide if a patient actually requires a surgical treatments and to predict if these will be successful.

Within the Virtual Physiological Human Initiave European scientists co-ordinated by Barcelona’s IBEC are working on the development of a ‘virtual spine’. The goal of the EU-funded FP7 MySpine project (March 2011-2014) is to create a patient-specific predictive platform to help clinicians in making decisions on how to treat various back pathologies, such as degenerative disc diseases.

“We will develop computation models that are able to predict the biomechanics of the spine and therefore the forces that are acting in the intervertebral discs and in the vertebrae. Then we will we acquire imaging (CT and MRI scans) for the specific patient and use these data to create a biomechanical model to predict the forces that are acting within the spine of that specific patient and will relate these forces with the state of degeneration of the disc”, coordinator Damien Lacroix, head of IBEC’s Biomechanics and Mechanobiology group and president of the European Society of Biomechanics, explains. “The objective is to predict over about five years whether the disc of the patient will degenerate or remain stable and what will happen in the vertebra and depending on the results we will advice the clinicians to do surgery or not and will also investigate different possible types of surgery. Since changes in the disc also affect the vertebrae we are looking not only at the disc that has some pathology but also the other discs that are still healthy, so that we can see whether the ones that have not degenerated yet are likely to in the next years”.

The idea is also to treat each patient in a different way by accounting for differences in terms of spine geometry, mechanical properties (state of degeneration of the discs but also gender and age) and the level of activity of the person (through simulation of different kind of activities).

“The project seems exciting and both the prediction and the patient-specific aspect of it are pretty revolutionaries”, says Melanie Kinchen, an orthopaedic surgeon specialized in spine surgery independent from the project and medical director at Baylor Regional Medical Center, Grapevine Texas. “I think the proposal is great in terms of what surgery could structurally do to someone. What I am not sure of is how the model can predict whether or not degenerative changes give someone pain because I see people with severe degenerative changes in their back but little pain and people with minimum changes and horrible pain. As a doctor my biggest concern is if after the operation the pain goes away”. Rather than for degenerative disc disease Kinchen sees the model more useful for someone who perhaps has spinal stenosis and a curve in his spine and in general for older people, whose problems are more defined than youngsters’.

“We think that biomechanical changes in the spine lead to disc degeneration and we assume that it is a biomechanical change to generate pain”, Lacroix says. "In our clinical study we will correlate the morphological changes and biomechanical study with the perception of improvement or worsening of quality of life of the person. Basically we will surely try to answer this doubt at the end of the project”.

The two year clinical trial will enroll around 200 men and women between 30 and 50 years old, who already have some disc degeneration, to validate the prototype. “We are targeting younger patients because it is more difficult for doctors to take the best decision on them” Lacroix points out.

The prototype created by MySpine will be a ‘graphical-user interface’ to be used by doctors and a calculation program. “Hospitals”, Lacroix explains, could either own the whole program or they could send the MRI of their patients to a remote calculator for instance at IBEC itself and have the results back, ‘we hope in less than 24 hours for each patient’ so to be able to make a decision.

According to the project co-odinator the most direct application of this tool “would be other applications within the spine first, such as vertebrae fractures, but also osteoporosis for instance” while Kinchen highlights joints, fixing ankles, spine or neck among others.

Lacroix cannot say yet how much money it could cost a hospital, for instance, to own the program. “Our effort is to develop it all within an open-source platform. Programs would be therefore free. What might be expensive is the development and monitoring of the program. We should either create a spin-off or find a company that might be interested in buying the technology and exploit it for commercial purposes”.

 

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