**3. Study 2: exploratory (pilot) randomised control study (RCT)**

### **3.1 Research design**

The study was initially going to be carried out as a randomised control trial (RCT) for 24 months. The RCT study design is considered to be the highest level of scientific testing as it minimises patient control bias [25]. However, halfway through the recruitment process, it became apparent that the numbers required to achieve an RCT would not be met due to a number of factors that were out of the control of the research team. These factors included a drop in patient referrals due to a reform in the referral process from primary care into secondary care, a lack of engagement by treatment centres in terms of not fully understanding which healthcare professionals could refer patients into the trial and a small number of eligible participants who matched the study inclusion criteria. Therefore, after the discussions with the consultants, brace clinicians and research team, it was decided that the best solution to these problems would be to continue the trial as a prospective study with a control group for 6 months. There are several reasons for the reduction in the trial time scale. Firstly, it took over 13 months to gain NHS ethics; secondly, the participant referrals dramatically decreased after the first 12 months due to NHS reforms, and therefore any new entries into the trial would not have finished their treatment program before the scholarship of the primary author concluded. Therefore, recruitment was halted after 18 months. As a result of this, the data presented in this work are from 6 months of data collection.

### **3.2 Recruitment of participants**

The participants for the study were recruited and identified by consultants, physiotherapists and spinal nurses when they attended their regular orthopaedic clinics. When attending these appointments, the patients were screened by their consultants to ensure they were suitable and matched the study criteria. Participants for the study were initially going to be recruited from three different treatment centres; however, only one referred any participants into the trial. Once a participant was referred into the trial, they were randomised into either the treatment or control group; this was done through a computer randomisation program. Participants in the treatment group received the soft brace in addition to the standardised assessment tools described below.

### **3.3 Participant inclusion/exclusion**

To ensure that appropriate patients were recruited for the trial, after a number of discussions amongst the research team, brace manufacturers, surgeons and physiotherapists, a set of inclusion and exclusion criteria was drawn up. This was to ensure

that the participants would be able to fully partake in the trial without having any additional problems or issues placed upon them as a result of participating.
