Participants' and physiotherapists' views on the delivery of a randomised controlled feasibility trial investigating a bespoke dynamic elastomeric fabric orthosis for women with chronic pelvic girdle pain: a qualitative exploration.

BACKGROUND: Chronic pregnancy-related pelvic girdle pain (PPGP) affects approximately 10-30% of postpartum women beyond 3 months. Such pain is typically recalcitrant to standard care. A dynamic elastomeric fabric orthosis (DEFO) is one option. A feasibility randomised controlled trial (fRCT) assessed the feasibility and acceptability of trial design, interventions and data collection. The aim of this qualitative sub-study was to explore the experience of women participating in the feasibility trial, and physiotherapists delivering the trial intervention. METHODS: An embedded qualitative study within a fRCT. The fRCT randomised participants to either control (standard care involving advice and exercise) or intervention (standard care and DEFO), across three healthcare trusts in three regions of England. Delivery of all interventions and data collection was undertaken remotely. Participants were encouraged to wear the DEFO for a maximum of 12 h a day over the 24-weeks of the trial. The qualitative approach involved online, semi-structured interviews supported by a topic guide. Data was recorded, transcribed verbatim, and analysed using thematic analysis. RESULTS: Seven (n = 5 intervention, n = 2 control) of 24 participants recruited to the fRCT and five of the seven physiotherapists involved in the trial intervention delivery participated. Four main themes were identified: "acceptability of trial methods", "intervention acceptability", "impact of intervention" and "adherence to exercise". Data collection methods were acceptable using the web-based app. The virtual nature of the trial was acceptable; however, women and physiotherapists would have preferred at least one face-to-face intervention session. The DEFO was acceptable to women, providing them with a sense of support "holding them together". They felt it increased awareness of their ability to move, enabling them to be more physically active. Physiotherapists' felt the process of delivery of the DEFO was acceptable but felt the range of available exercises they could prescribe was restrictive. Physiotherapists and participants found the advice component required further development. Participants struggled to maintain adherence to the prescribed exercise programme over the 24-week period. CONCLUSIONS: The remote trial procedures and interventions were generally acceptable to both participants and physiotherapists, supporting the overall trial design and implementation, but a future design should incorporate an in-person treatment component. The participant's experiences and suggestions will be considered in the design and delivery of a future definitive trial. TRIAL REGISTRATION: ISRCTN67232113.