Journal Article

Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): a randomised controlled feasibility trial

Chynoweth, Jade, Carter, Kirsty, Freeman, Jennifer, Hawton, Annie, Cameron, Lee, Stockley, Lauren, Hayward, Chris, Shawe, Jill, Hosking, Joanne, Halliday, Bradley, Chatfield, Sarah, Bailey, Matthew

2025

Overview

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 . Key messages • What uncertainties existed regarding the feasibility? ➣ There is uncertainty regarding the feasibility of recruiting participants at a rate conducive to a definitive trial. • What are the key feasibility findings? ➣ Twenty-four participants were recruited over 7 months. Retention and complete NPRS data were available for analysis at final follow-up for 18 participants (75%). ➣ Overall, the trial procedures and interventions were perceived as acceptable by participants and clinicians. ➣ Overall recruitment was insufficient to estimate a signal of efficacy with confidence. ➣ Technical issues with the Orthotimer significantly impacted on adherence data collection. ➣ Progression criteria indicate that progression to a definitive trial in its current format is not recommended. • What are the implications of the feasibility findings for the design of the main study? ➣ Further research is required to best understand how to recruit women to a future study. ➣ A hybrid approach to intervention delivery may be preferable. ➣ Orthotimer reading intervals for capturing orthosis wear-time adherence require careful consideration. ➣ An internal pilot within a future definitive multicentre randomised controlled trial would add value.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Biomedicine / Care and treatment / Cost analysis / Data collection / DEFO / Feasibility / Feasibility trial / Health aspects / Health Sciences / Intervention / Medicine / Medicine & Public Health / Orthosis / Pain / Pelvic girdle pain / Physical therapy / Postpartum depression / Pregnancy / Pregnant women / Quality of life / Questionnaires / Regulatory compliance / Rehabilitation / Social networks / Software / Statistics for Life Sciences / Therapeutics, Physiological / Womens health