Abstract
BACKGROUND: Postpartum pelvic girdle pain (PGP), experienced by approximately 10% of women, is typically refractory to conservative management. Customised dynamic elastomeric fabric orthoses (DEFOs) are one novel option to address this. We assessed the feasibility and acceptability of a randomised controlled trial comparing a DEFO plus standardised advice/exercises (intervention) versus standardised advice/exercise alone (control). METHODS: A multicentre randomised controlled feasibility trial with embedded qualitative study and economic evaluation. Participants were randomised to either intervention or control group. All received two remote physiotherapy sessions via videoconferencing separated by 14 days. Primary feasibility outcomes were related to the feasibility and acceptability of methods and interventions, recruitment, intervention fidelity, outcome measure performance and completion. The proposed primary outcome measure for the definitive trial was the Numerical Pain Rating Scale (NPRS) which assessed pain intensity fortnightly over 24 weeks. Secondary outcome measures assessed kinesiophobia, continence, function, health-related quality of life, depression and health/care resource use at baseline, 12 and 24 weeks. Adverse events were recorded. Pre-defined progression criteria were set to decide whether, and how, to proceed with a future definitive trial: (1) Target sample size (60 from 3 centres over a 7-month recruitment period), (2) outcome measure completion (> 60% at 24 weeks), (3) orthosis wear-time compliance (> 70% for 6 h/day) as measured by the Orthotimer, and (4) evidence suggesting efficacy. RESULTS: Of 180 participants sent information sheets, 40 were screened and 24 randomised. At 24 weeks, 95% completed NPRS and 89-95% the secondary outcome measures. Wear-time adherence appeared below the set target of 42 h per week. Outcomes were broadly comparable between groups. Recruitment was insufficient to estimate a signal of efficacy with confidence. Two intervention participants experienced Candida infections, considered possibly due to the DEFO. CONCLUSIONS: Trial procedures and interventions were acceptable to participants. Technical Orthotimer issues are resolvable through modification of recording parameters. Recruitment of participants was a major challenge. Work to understand how best to engage women in this research is needed before moving to a definitive trial. TRIAL REGISTRATION: ISCRTN, ISRCTN67232113. Registered 08/05/2021, https://www.isrctn.com/ISRCTN67232113 .