Back pain is a significant socio-economic problem affecting around 80% of the population at some point during their lives. Chronic back pain leads to millions of days of work absence per year, posing a burden to health services around the world. In order to assess surgical interventions, such as disc replacements and spinal instrumentations, to treat chronic back pain it is important to understand the biomechanics of the spine and the intervertebral disc (IVD). A wide range of testing protocols, machines and parameters are employed to characterise the IVD, making it difficult to compare data across laboratories.

The aim of this study was to compare the two most commonly used testing protocols in the literature: the stiffness and the flexibility protocols, and determine if they produce the same data when testing porcine specimens in six degrees of freedom under the same testing conditions. In theory, the stiffness and the flexibility protocols should produce equivalent data, however, no detailed comparison study is available in the literature for the IVD, which is a very complex composite structure.

Tests were performed using the unique six axis simulator at the University of Bath on twelve porcine lumbar functional spinal unit (FSU) specimens at 0.1 Hz under 400 N preload. The specimens were divided in two groups of six and each group was tested using one of the two testing protocols. To ensure the same conditions were used, tests were firstly carried out using the stiffness protocol, and the equivalent loading amplitudes were then applied using the flexibility protocol.

The results from the two protocols were analysed to produce load-displacement graphs and stiffness matrices. The load-displacement graphs of the translational axes show that the stiffness protocol produces less spread between specimens than the flexibility protocol. However, for the rotational axes there is a large variability between specimens in both protocols. Additionally, a comparison was made between the six main diagonal terms of the stiffness matrices using the Mann-Whitney test, since the data was not normally distributed. No statistically significant difference was found between the stiffness terms produced by each protocol. However, overall the stiffness protocol generally produced larger stiffnesses and less variation between specimens.

This study has shown that when testing porcine FSU specimens at 0.1 Hz and 400 N preload, there is no statistically significant difference between the main diagonal stiffness terms produced by the stiffness and the flexibility protocols. This is an important result, because it means that at this specific testing condition, using the same testing parameters and environment, both the stiffness and flexibility methods can be used to characterise the behaviour of the spine, and the results can be compared across the two protocols. Future work should investigate if the same findings occur at other testing conditions.

Chronic back pain is the leading cause of disability worldwide, affecting millions of people. The source of pain is usually the intervertebral disc (IVD), thus there has been a growing interest in developing new improved implants such as disc replacements to treat the condition. However, to ensure the artificial devices being designed replicate the intact disc, the biomechanical behaviour of the IVD must be well understood (Adams and Dolan, 2005). The two most widely used testing procedures in the spinal industry to characterise the behaviour of the disc are the flexibility and the stiffness protocols (Stokes et al, 2002 and Panjabi et al, 1976).

For elastic specimens, the results produced by the flexibility and the stiffness protocols should in theory be identical. However, this does not hold true for inelastic specimens, such as the IVD. For this reason, the custom developed Spine Simulator (Holsgrove et al, 2014) at the University of Bath has been used to compare, in six degrees of freedom, the extent of the difference produced by these two testing protocols.

A biomechanical model of the IVD was tested, which consisted of two cylindrical nylon blocks attached together with a layer of nitrile rubber, representing respectively the vertebral bodies (VB) and the IVD. Two steel pins were inserted into the VB, spanning the thickness of the disc, to ensure the stiffness raise either side of the neutral zone was replicated by the model. Tests were performed at a frequency of 0.1 Hz using triangular wave cycles. The specimen was firstly subjected to the stiffness protocol, characterised by displacements of ±0.5 mm in anterior-posterior and lateral shear, ±0.35 mm in axial compression and ±1.5 deg in all rotational axes. The resulting loads were applied to the specimen when subjected to the flexibility protocol. In addition, the effect of a preload was studied by testing specimens with an axial compressive load of 250 N.

The stiffness matrix was calculated for each test and the main diagonal terms produced for the two protocols were compared using the Mann-Whitney test. Overall, results showed that there was a significant difference in the stiffness terms produced by the two protocols when tests were performed with (p ≤ 0.016) and without (p = 0.004) a preload. The only exception was found in the flexion-extension axis when the test was performed with a preload (p = 0.337). Additionally, differences were also recorded when comparing the shape and linearity of the load-displacement hysteresis curve (Figure 1) and the area enclosed by the curve.

This preliminary study has provided important information regarding the differences in the data produced by the flexibility and the stiffness protocols, it is therefore impractical to compare results produced using these two methods. To ensure that in the future results can be compared across laboratories, there is a need for a standardised testing procedure in the spinal industry.

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Introduction

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Introduction

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Introduction

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