*3.14.2 EQ5D*

The data presented in **Table 4** show that at baseline, the control group's reported health state appeared worse than the treatment group. As the score gets closer to 0, the closer the individual feels to a state of death. The control group had an initial TTO 22.2% higher than that of the treatment group even before receiving the brace, which means that they felt less well than those in the treatment group. The mean TTO data from month 3 showed that both groups' health state changed, with a 21.4% increase coming from the control group, and the treatment group's mean TTO score improved by 10.62%.

Data from the 6-month collection point presented a further increase for the treatment group with an improvement in score of 7.69% and with an overall increase in score of 18.31% over the duration of the study with regard to their TTO health state. Furthermore, although no change in score was found for the control group in the final 3 months, over the full duration of the study, a total improvement of 22.2% was calculated. From the EQ5D questionnaire, it was also found that over the course of the 6-month study period, no statistically significant differences were found between the groups' TTO scores or in-group interaction.

### *3.14.3 SF-36 mental health scores*

The results from the initial month's questionnaires show that both groups of patients had similar mean scores in terms of their mental health (see **Table 5**). After 3 months in the brace, the treatment groups reported mental health score decreased by 8.26%. However, this change in reported mental health was smaller than that of the decrease calculated from the control group questionnaires whose mean score decreased by 11.84%. The results from the month 6 time point indicated that both


### **Table 4.** *EQ5D health states over 6 months.*

*A Mixed Methods Study of the Experiences and Effectiveness of a Soft Brace for Adults… DOI: http://dx.doi.org/10.5772/intechopen.92387*


### **Table 5.**

*SF-36 mental health scores.*

groups' mental health increased between the months of 3 and 6. The treatment groups' mean scores increased by 4.87%, whilst the control group's score increased by 6.94%.

### *3.14.4 SF-36 physical health scores*

The initial month's mean SF-36 physical health scores show that the treatment group had an inferior physical health score of 25% compared to the control group, as the closer the score to 0, the lower the individuals' physical health. Data collected from 3 months into the study show that wearing brace for 3 months leads to the treatment group having an increase in their scores of 16.95%. This was in comparison to the control group, whose scores showed signs of their physical health decreasing by 3.31%. The scores calculated from data collected between the months of 3 and 6 show the treatment group's mean physical health decreased by 3.67%.


### **Table 6.** *SF36 physical health scores.*

The results also demonstrated that no significant differences or group interactions were found between the treatment group's physical health score and the control group's physical health score at 6 months (**Table 6**).

### **4. Discussion**

### **4.1 Aims of the study**

The primary aim of this study was to obtain both patients' quantitative experiences of living with scoliosis together with developing an understanding of the pain they experienced and their quality of life. The secondary aims of this study were to investigate the effects the soft brace had on adults with degenerative scoliosis. Another aim of the study was to compare the questionnaire results from the treatment group against the questionnaire results from adults who did not receive the soft brace.

### **4.2 Summary of main results**

The study inclusion and exclusion criteria were designed to recruit individuals who were at the end of the non-operative treatment pathway. For these participants the next stage of treatment would be surgery. However, as discussed previously, due to the complications and difficulties of the procedure, the need for a surgery should if possible be delayed or avoided especially in those patients who have additional underlying health conditions such as irritable bowel syndrome (IBS) and arthritis. These dangers are further highlighted as the complication rates of surgery in older adults range from 20% to as high as 80% [48].

The anthropometric data of nine patients (8 female, 1 male) in the treatment group and six (all female) in the control group were as follows: the female patients in the treatment group had an average weight of 75.3 kg with an average height of 155.4 cm; the one male participant had a height of 165.2 cm and weight of 84.7 kg. This is in comparison to the six female participants recruited into the control group, who had an average weight of 77.6 kg and average height of 153.8 cm. In comparison to the average healthy individual who has an ODI score of 10.19 [49], the mean ODI score of the individuals in this trial was 47. Moreover, the mean ODI score of 47 was also substantially higher than the minimum ODI score of 32 outlined in the initial study inclusion criteria. In comparison the control group showed an 8.18% increase in ODI in comparison to the data collected between the initial month and month 3.

The results further demonstrated that there were no significant differences or interactions between the treatment group's physical health score and the control group's. The average healthy individual has an ODI score of 10.19 [49], whilst the mean benchmark ODI score of the individuals in this trial was 47. Moreover, the mean ODI score of 47 was also substantially higher than the minimum ODI score of 32 outlined in the initial study inclusion criteria. In addition to a higher mean ODI score than the average healthy individual, participants also had a lower mean score in terms of SF-36 MH and SF-36 PH than the average healthy individual. A healthy individual's SF-36 MHS score is on average 50.17 and PHS 50.1 [50].

The mean baseline mental and physical health scores of the patients in this trial were 45.5 and 26.4, respectively. Additionally, a mean health TTO score of the average healthy individual is 0.94 [51] compared to the mean TTO score of 0.32 obtained from those in this trial. Furthermore, the inclusion criteria required participants' Cobb angle to be a minimum of 20. The average Cobb angle measurement of patients in this trial was 43° (+/−12), again highlighting the severity of the degenerative scoliosis our participants had. The questionnaire data showed that over the course

### *A Mixed Methods Study of the Experiences and Effectiveness of a Soft Brace for Adults… DOI: http://dx.doi.org/10.5772/intechopen.92387*

of 6 months, patients treated with a soft brace had a reduction in their ODI score regarding the 'pain they felt today'. However, no significant differences or interactions were observed over the 6 months of the trial. In addition to the change in the ODI scores, changes in the TTO and mental and physical health scores were also calculated from the treatment group's data. However, again no significant differences were found between questionnaire scores.

Like the treatment group, participants in the control group also showed no significant changes over the course of the 6-month study period. Furthermore, as seen in the tables above, the participants in the control group had a lower baseline ODI, EQ5D and SF-36 scores than the average healthy individual. It was difficult to compare the results of this study to previous work as little research has compared braced patients with patients who received no or standard NHS treatment. Furthermore, although several studies have been published [9, 52], these investigated the effectiveness of bracing on adolescents which has a different aetiology to adult scoliosis.
