| Abstract |
Introduction
Many researchers wade into assessment of mobility and functionality of the spine and its curves. Various non-invasive methods have been developed for the measurement of the above parameters. However, most of these methods either have a poor reliability or validity or are time-consuming. In addition, most methods have individual recording capability, either in the sagittal or frontal plane only. Moreover, plain radiograph and Computed Tomography (CT) provide potential for imaging one part only of the spine. Imaging of the entire spine results in significantly higher radiation burden. Magnetic Resonance Imaging (MRI) could act as alternative but it is limited of its high cost and the inability to dynamically examine the spine in conventional MR scanners.
For the abovementioned reasons, in assessing the functionality of the spine and for cases where repeated examinations are required, a valid, reliable, non-invasive and safe method, with low cost, short examination time and the ability of performing multiple clinical tests in sagittal and frontal plane, would be desirable.
One such method is the Spinal Mouse. Although the reliability and the accuracy of the method, both between examiners and between measurements were assessed in previous studies, however they concerned only healthy population and children. Also, there is no study evaluating the validity and reproducibility of the method in the frontal plane. For this reason, it is necessary to assess the reliability and validity of the method in two planes in subjects with spinal pathology, to ensure the possibility of using the method in similar population.
Furthermore, two of the most common invasive procedures for the treatment of the spine are Balloon Kyphoplasty Procedure (BKP) and spinal fixation-fusion. However, for none of these methods the postoperative process, the morphology and the mobility of the spine as a whole, have been investigated in both sagittal and frontal plane.
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Purpose
The aim of this thesis is the evaluation and the application of a new method for the assessing of the spine in patients who have undergone spinal fixation surgery or BKP. Furthermore, the aim is to evaluate the entire spine and its individual parts either separately or in correlation with each other, in two planes, as it is proven that any change in any part of the spine affects its entire structure.
For this purpose, the study has been divided into three phases:
A) In the first phase paired t-test and repeated measures analysis of variance were used to assess the reliability of the method, in participants with symptoms of low back pain and/or back pain.
B) In the second phase, evaluation of morphology and mobility of the spine in patients with spinal stenosis who have undergone decompression and posterior fusion with pedicle screws and robs, were performed (prospective cohort study).
C) In the third phase, the purpose was to provide further evidence for the evaluation of the morphology and mobility of the global spine, in patients with vertebral fractures-VF (prospective cohort study)
Methods
All participants were informed in detail about the purpose and the procedures of the study and provided written consent, according to the Bioethics Committee of the University Hospital of Heraklion, Greece. The Scientific Committee of the University Hospital of Heraklion, Greece, had approved the study (10787/20-12-10).
Technique and measurement procedure
The mobility of the spine was evaluated with the Spinal Mouse (Idiag, Volkerswill, Switzerland), a computer-assisted wireless telemetry device. This portable device is guided along the spinous processes of the vertebral column. The values obtained are transferred in real time to a computer
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device
. The recording frequency was 150Hz. All measurements followed the same procedure and were performed in the same order. The recording was performed from the processus spinosus of C7 to S1-S2. The recording frequency was 150Hz. The mobility of the curves was calculated with a periodical algorithm.
The measurements’ positions involved:
- Sagittal plane: a) Upright position, b) full flexion, c) full extension.
- Frontal plane: a) Upright position, b) left lateral bending, c) right lateral bending.
Overall, 24 parameters of the functionality of the spine and posture were counted and calculated for each plane:
- In the sagittal plane: The thoracic curvature (T1-T12), the lumbar curvature (L1-L5), the hip-sacral angle (Sac_Hip) and the total trunk inclination (Incl) were assessed. These parameters were measured by the examiner in all positions. Moreover, the mobility of the spine was determined with the software of the device for the following movements: From the upright position to full flexion (AF), from the upright position to full extension (AE) and from full bending to full extension (FE).
- In the frontal plane: The thoracic and lumbar curvatures, the Sac_Hip and the Incl were evaluated in all positions. The mobility of the spine was calculated with the device software for the following movements: From the standing position to full left lateral bending (SL), from the standing position to full right lateral bending (SR) and from full left lateral bending to full right lateral bending (LR).
It is necessary to mention that this method can assess and evaluate only the curvatures and the mobility of the spine, and extend only measurements that fall into these categories.
Phase A (Evaluation of the method)
The test-retest reliability was evaluated in 50 adults (12 men, 38 women) who attended the Outpatients’ Spine Unit of the University Hospital of Heraklion, with symptoms of low back pain and/or back pain. Exclusion criteria were individuals
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with spine surgery in the past or those with permanently limited mobility of the spine, such as Morbus Bechterew, Paget's disease and diffuse hyperostosis.
Phase B (Spinal fixation-fusion)
The Treatment Group (TG2) consisted of 45 patients who underwent posterior fusion of the thoracic, lumbar or thoracolumbar spine. Thirty eight completed the evaluation process. The Control Group (CG) consisted of 39 healthy subjects. Mobility and curvatures of the spine were measured with a wireless radio-frequency device, the Spinal Mouse. The Visual-Analogue Scale (VAS) was used to evaluate pain. The Oswestry Disability Index (ODI) was used to evaluate the degree of the functional disability and the Short Form (36) Health Survey (SF-36) was used to evaluate the quality of life. The measurements were recorded preoperatively and at 3, 6 and 12 months postoperatively.
Phase C (Kyphoplasty)
The TG3 consisted of 43 patients who underwent percutaneous BKP or BKP plus fixation. Thirty nine completed the evaluation process. The CG consisted of 39 healthy subjects. Spinal mouse was used for the assessment of the curvatures and the mobility of the spine. Clinical outcomes were evaluated by VAS and ODI. The measurements were recorded at 15 days, 3, 6 and 12 months postoperatively.
Results
Phase A
In the sagittal plane, the intraclass correlation coefficient (ICC) showed high (0,90-0,99 ICC) and good reliability (0.80–0.89 ICC), in most of the parameters (22 of the 24). The two other parameters which exhibited poor reliability are not measured data, but calculated by the software of the device. To determine the reliability the standard error of measurement (SEM) was calculated for each variable. The SEM ranged from 0.322o for the lumbar curvature in full flexion to 4.965o for the range of AF of the thoracic spine.
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In the frontal plane 17 parameters showed high and good reliability. The SEM ranged from 0.958o for the Incl in upright position to 4.820o for range of LR for the lumbar curvature.
Phase B
Lumbar lordosis and thoracic curvature were increased whereas the Incl of the pelvis was reduced, without statistical significance. The mobility of the lumbar spine in the sagittal plane was increased (p=0.01) at 12 months in comparison with the evaluation at 3 months. The mobility of the thoracic spine in the frontal plane was increased (p=0.009) at 12 months in comparison with the preoperative evaluation. The results of VAS, ODI and SF-36 PCS exhibited improvements (p<0.001). The SF-36 MCS exhibited the greatest improvement (p=0.004) at 12 months in comparison with the preoperative evaluation. The number of the fusion levels exhibited a significant linear correlation with the SF-36 PCS, VAS and mobility of the lumbar spine during extension (0.5≤|r|<0.7).
Phase C
Regarding the curvatures and mobility in sagittal plane, a statistically significant increase appeared early at 3 months, for lumbar curve, Sac_Hip and Incl. In the frontal plane, most of the improvements were recorded after 6 months. According to the type of VF, patients with osteoporotic fracture showed statistically significant lower mean value than patients with traumatic fracture. Also, people with osteoporotic fractures tended to experience chronic pain. Pain and disability index showed early improvements. However, the TG3 was inferior at the final evaluation compared to the CG. Finally, one out of 10 participants experienced pain even at 12 months’ re-evaluation.
Discussion-Conclusion
Regarding the validity and the reliability of the method, for the sagittal plane, the results of this study coincide with those of other researchers in healthy population, while showing better results than the assessments performed in children. Slightly less strong reliability showed in the frontal plane compared to the sagittal plane. However,
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measurements present high and good reliability. The worst results with poor repeatability shown in Sac_Hip, fact that needs further investigation. In conclusion, the presented method seemed to be a very good and reliable tool for the evaluation of curves, deformities and mobility of the spine, and the position of the trunk. Due to the fact that the method is non-invasive and without radiation is ideal in cases where multiple examinations are required
Also, the subjects that underwent spinal fusion showed improvement in the evaluations of pain and quality of life. Functionality and mobility of the spine were significantly improved both in the sagittal and frontal planes.
Finally, this study provides a comprehensive and complete picture of the morphology and mobility of the spine in patients treated with BKP. Both BKP and BKP plus fixation, show significant early improvements regarding structure and mobility of the spine, especially in lumbar spine and Sac_Hip, which improve posture, balance and quality of life. However, the increased mobility that some participants presented was a negative factor for their rehabilitation. Moreover, although the pain and ODI responses decreased significantly, 1 in 2 participants characterized as patient with chronic pain. Yet it appears that the BKP had better results in people with traumatic fractures, than in patients with osteoporotic fractures.
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