Title: Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): A randomised controlled feasibility trial
Funder: Department of Health and Social Care

Abstract: Research Question: The purpose of this study is to evaluate the feasibility of conducting a definitive, multi-centre, assessor blinded, pragmatic randomised controlled trial (RCT) asking &ldquo;What is the clinical and cost-effectiveness of customised pelvic support shorts plus standardised information and exercises (intervention) versus standardised information and exercises alone (usual care) in women with chronic severe post-partum pelvic girdle pain?&rdquo; Background: During pregnancy, pelvic girdle pain is common. Although such pain usually reduces after childbirth, approximately 10% of women continue to suffer severe and chronic pain (> 3 months) following delivery; with some enduring this pain for over a decade. Such pain significantly affects everyday activities such as moving in bed, walking, carrying items, driving, and caring for their child. Despite the significant impact of this on women s quality of life, this remains an under-researched area. Usual treatment offered involves physiotherapy, which typically includes advice, exercises, and &ldquo;off-the-shelf&rdquo; rigid maternity support belts. These belts aim to stabilise the pelvis in good alignment. Unfortunately, women often find them uncomfortable and difficult to use. Consequently many choose not to wear them. We have undertaken a series of studies developing a customised pelvic support, specifically aimed at people with severe pelvic girdle pain. Designed as &ldquo;pelvic support shorts&rdquo; customised to the individual s particular anatomy, initial testing in women with chronic postpartum pelvic pain shows promising results. However, a powered RCT trial is required to establish clinical and cost effectiveness. Research Aim: This feasibility study aims to obtain the data and operational experience necessary to inform the conduct and finalise the design of a definitive RCT. In particular, we will assess recruitment and retention rates, outcome measures, completion rates, and adherence to the intervention. We will also gather women s views about the &ldquo;support shorts&rdquo; and the trial. Designs and methods: 60 women with severe, persistent (> 3months) postpartum pelvic girdle pain, will be recruited from physiotherapy departments, women s health services, GP surgeries and via social media forums. They will be randomly allocated to either the &ldquo;support shorts&rdquo; intervention group or to usual care. Following screening and consent, all will complete web-based self-report questionnaires (pain, function, continence, depression, quality of life, medication usage, health resource utilisation) at baseline, 3 and 6 months. Fortnightly scoring of pain and medication usage throughout the study timeframe complements this. Fifteen women and five clinicians will be interviewed to explore their experiences of wearing/providing the &ldquo;support shorts&rdquo; and participating in the trial. Patient and public involvement: We have involved women with pelvic girdle pain over the past 11 years in our research, integrating their views to determine the correct research questions, trial procedures, outcome measures and the design of the &ldquo;support shorts&rdquo; themselves. They will continue to have input throughout the life of this and future studies. Dissemination: Via professional and research journals and conferences, social forums, grass-root level physiotherapy meetings, and popular women s magazines.

Lay abstract: Background: During pregnancy, joint and muscle pain related to the pelvic girdle is common. Although such pain usually reduces after childbirth, almost 20% of women continue to suffer three months afterwards. Ten percent of women still suffer significant pain two years later and some for over a decade. When severe, this pain affects everyday activities such as moving in bed, walking, carrying items (including their child), cooking and driving, and caring for their child. Usual treatment offered involves physiotherapy, which typically includes advice, exercises, and &ldquo;off-the-shelf&rdquo; rigid maternity support belts. These belts aim to stabilise the pelvis and hold the joints in good alignment. Unfortunately, women often find them uncomfortable and difficult to use. Consequently many choose not to wear them. Our research team has undertaken a series of studies developing a customised pelvic support, specifically aimed at people with severe pelvic girdle pain. Designed as &ldquo;pelvic support shorts&rdquo;, they are customised to each woman s particular anatomy. Our initial testing in eight women with long-lasting pelvic pain following pregnancy has shown promising results. However, these support shorts need to be tested in a large study of women who suffer from long-term pain before we could recommend their use. We need to be sure that such a study is possible. Research Aim: The aim of this initial study is to assess whether a larger trial evaluating the new pelvic support is feasible. In particular we will assess whether we can find women who want to wear the support, whether they are happy to go into the study, and whether we can gather outcome information from all of them. We will also gather their views about the &ldquo;support shorts&rdquo; and about the study. Designs and methods: This study will involve 60 women with severe pelvic girdle pain, recruited from physiotherapy departments, women s health services and GP surgeries. Women will be randomly allocated to receive either the &ldquo;support shorts&rdquo; plus physiotherapy advice and exercises, or to receive physiotherapy advice and exercises alone. All will complete web-based self-report questionnaires (pain, function, continence, depression, quality of life). Fifteen women and five clinicians will be interviewed to explore their experiences of wearing the &ldquo;support shorts&rdquo; and participating in the trial. This will inform the design of a future large trial. Patient and public involvement: We have involved women with pelvic girdle pain over the past 11 years in our research, integrating their views to determine the correct research question, trial procedures, outcome measures and design of the &ldquo;support shorts&rdquo;. Patients will continue to have input throughout the life of this and future studies. Dissemination: Our results will be available via professional and research journals and conferences, social forums, grass-root level physiotherapy meetings, and popular women s magazines.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH