The intensity of pain before using the orthosis averaged 7,88. During the period the patients received orthotic treatment this value was reduced to 2,63.
All patient in the survey were unable to perform business, household or leisure activities or could only perform them with restrictions. When using the brace the performance of all these activities was made possible or at least improved.The intensity of pain when sitting, standing or lying could be reduced significantly by the use of the orthosis: from an average of 5,50 to 2,25 when sitting, from 8,00 to 5,25 when standing and from 5,25 to 4,25 when lying (Figure 1).Side effects of the orthosis like pressure marks were reported by 25 percent of the patients, which must be considered normal according to the circumstances. Putting the brace on and off was perceived as minor inconvenience by 25 percent. Three quarters of the patients reported no pressure marks or pains caused by the orthosis whatsoever (Figure 2).
In three cases a surgical intervention could be avoided by the use of the brace.
Two case examples
Case 1: symptoms and indication
The patient in this case was a 65 year old woman who had a spinal fusion operation. Her body did not tolerate the implants and they had to be removed. Following the operations and recuperation the original situation was restored: The diagnosis was degenerative scoliosis concomitant with kyphosis of the lumbar vertebral column and pseudarthrosis between L5 and S1.The patient (Figure 3) had multiple degenerative deformations and was suffering with severe back pain (NRS 8–9). Even minor everyday activities were impossible to accomplish: She stated that the pain prevents her from walking upright and driving even short distances. When specific physiotherapeutic treatment brought no relief, the patient chose the surgical intervention which was unsuccessful for the time being.
The independent handling of daily routines was impossible without stabilizing the lumbar spine and easing the pain. In this phase the patient assessed her quality of life and her social life as 3 on a scale of 1 to 10.
Case 1: Required features and design of the brace
In this case the back brace had to be able to stabilize the spine in the affected lumbar segment in order to stop and reduce the stenosis of the spinal canal. This could only be achieved by changing the body statics. At the same time it had to keep the body in a pain-free position. Furthermore a correction of statics and a normalization of the sagittal profile was targeted. The functionality of the thoracolumbosacral orthosis (TLSO) had to be ensured in standing, lying and sitting position without any restriction of mobility.The patient was equipped with a sBrace L TLSO trunk orthosis module (Figures 4 and 5). The biomechanic design of the orthosis module was adapted to the necessities of the specific case during the process of ordering. It was manufactured individually according to the measurements of the patient. She did not have to endure the process of making a plaster cast.
In the next step the brace was fitted to the patient according to the indication. Thus brim courses were defined and pressure zones cushioned. By this customization the trunk orthosis module was made into a lightweight rigid TLSO in frame construction. The flexibility of the frontal area was defined by the layout of the orthesis. In this case the mobility remained completely unrestricted.
Case 1: results
Judging from the comparison of clinical photography the sagittal profile of the patient was improved considerably (as shown in Figure 3), which also reduced pain significantly (NRS 3–4). The patient was able to use the orthosis for specific activities in everyday life and analgesic therapy – despite the strong malposition and deformations of the spine and the resulting pressure by the TLSO. She stated that she could live an almost normal life with the brace and assessed her social life now as 8 on a scale of 1 to 10.
After a subsequent successful operation she was able to give up the orthosis.
Case 2: symptoms and indication
The second example case is a patient (Figures 6 and 7) with degenerative scoliosis and long-term consequences of vertebral body fractures between L4 and Th8 concomitant with spondylolisthesis between L3 and L4. These resulted in chronic pain (NRS 8) which made independent mobility very difficult or even impossible. The patient reported severe pain especially when walking or lying down – the latter making her sleep troublesome und thus her life even more strained.
A surgical intervention was commended to treat the spondylolisthesis but the patient rejected it.
Case 2: required features and design of the brace
In this case the orthosis had to be able to stabilize the lumbar and thoracolumbar segments of the spine. The objective was to change the pathomechanic statics of the vertebral column to improve the spondylolisthesis and enable a pain-free posture.
For this patient the basic form of the sBrace L orthosis module was selected. The brace was manufactured according to the measurements and clinical pictures of the patient without plaster cast. The deviation of the pelvis to the right was integrated into the CAD model. The adaptation of the physiological sagittal profile of the brace’s basic form was based on clinical tests and the patient’s morphology. Furthermore, the left thoracic, the right lumbar and the left gluteal layout were integrated into the CAD model to ensure the three point pressure system to stabilize the frontal area. In the CAD model the pressure points were adapted to the morphology of the patient and to functional requirements.
Thus the biomechanically standardized basic form of the brace was individually manufactured by cutting the brim according to the requirements of the individual patient. Sensitive pressure zones were cushioned.
Case 2: results
The progression of the spondylolisthesis was stopped by the use of the brace and continued to be stable, as shown in Figures 6 and 7. According to the attending physician surgical intervention was avoided. The pain was reduced considerably (NRS 2) and the patient’s mobility in everyday life was ensured. Even leisure activities like light exercise were made possible by the orthosis.