EMaPP Feasibility Trial
Research type
Research Study
Full title
Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): A randomised controlled feasibility trial
IRAS ID
297938
Contact name
Jennifer Freeman
Contact email
Sponsor organisation
Royal Cornwall Hospital NHS Trust
Duration of Study in the UK
2 years, months, days
Research summary
Research Summary
Evaluating the Management of chronic Pelvic girdle pain following Pregnancy (EMaPP)
During pregnancy pelvic girdle pain is common. This pain will often reduce following childbirth, however almost 20% of women continue to suffer significant pain for at least three months afterwards. When pain is severe it will affect everyday activities and quality of life. Usual treatment typically involves Physiotherapy (advice and exercise) and provision of an “off the shelf” rigid pelvic support belt. Women often find these uncomfortable and difficult to use. A customised pelvic orthotic (referred to as pelvic support shorts) is an alternative that on initial testing has shown promising results in women with chronic pelvic girdle pain.
This feasibility study aims to obtain the data and operational experience necessary to inform the conduct and finalise the design of a future large randomised controlled trial. We will also gather women's views about the support shorts and the trial. It is vital to understand what treatments are beneficial to this group of women and this is the main driver for this National Institute of Health Research funded trial.
Following screening and consent, 60 women aged > 18 years, with severe, persistent post-partum pelvic girdle pain will be recruited into the trial. They will be randomised to receive either usual care (advice and exercise) or usual care and the customised pelvic support shorts. All women will receive 2 web-based sessions with a physiotherapist who will provide this intervention. All will complete web-based self-report questionnaires (pain, function, quality of life, continence, depression) at baseline, 3 and 6 months. Fortnightly scoring of pain and medication usage throughout the trial timeline complements this. Fifteen women and five clinicians will be interviewed at the end of the trial to explore their experiences of wearing/providing the “support shorts” and participating in the trial.
Summary of Results
PARTICIPANT LAY SUMMARY Evaluating the Management of Chronic Pelvic Girdle Pain following pregnancy: A randomised controlled feasibility trial (EMaPP) Bradley Halliday, Sarah Chatfield, Joanne Hosking, Annie Hawton, Jill Shawe, Lee Cameron, Kirsty Carter, Jenny Freeman
What was the problem?
Many women have pelvic girdle pain when pregnant. Some women will continue to have pain for weeks, months, or even years after childbirth. This can affect the activities that women do and their quality of life.
A previous study used customised support shorts to treat pelvic girdle pain during pregnancy. We did not know if they would be helpful to reduce pelvic girdle pain for women after childbirth. We used the support shorts in this study to see if they help after pregnancy.What did we do?
• We recruited 24 women with pelvic girdle pain, after childbirth, aged 20-48.
• 18 women were from Plymouth, 3 women from Milton Keynes and 3 women from Airedale.
• Participants were randomly assigned (allocated by chance) to 1 of 2 groups: support shorts plus standard exercise and advice, or standard exercise and advice, to test if one type of treatment had better results than the other (reduced pain).
• 11 women were randomised to the support shorts group and 13 women were randomised to the exercise group.
• All women were offered two virtual physiotherapy appointments to provide them with a personalised exercise programme. Women were asked to complete these exercises at home for 6 months.
• We used fortnightly online questionnaires to find out women’s level of pain and medication usage.
• We used a larger set of questionnaires at 3 and 6 months, looking at issues such as daily function and quality of life.
• We used sensors in the support shorts to measure how long they were worn over the 6 months.
• 7 women were interviewed at the end of their treatment to feedback their experience of the trial.
• 2 women withdrew from the trial and 1 woman did not attend any physiotherapy appointments.What did we find?
• Recruiting enough women was a significant challenge; we did not meet the target of 60. This was despite advertising widely through hospital trusts, health centres, primary schools, and social media.
• We could not determine whether or not the shorts were sufficiently effective to carry out a bigger trial in the future as a result of not recruiting enough women.
• There was some improvement in pain for both groups. Overall, both the exercises and the shorts appeared to have a positive impact for the women.
• Generally, women did not wear the shorts for long periods during the day, tending to wear them more when doing certain activities (e.g., walking/housework).
• Some women found the shorts uncomfortable to wear during hot weather.
• Women generally liked the virtual aspect of the trial but would have preferred a face-to-face component too.What did the interviews find?
7 women were interviewed about their overall experience of the trial. We gained useful information on running this type of trial. Key highlights of these interviews were:
1. How useful the web-based app was for filling out the questionnaires.
2. How some face-to-face contact would be valued in a future trial.
3. The generally positive impact the shorts had, giving women a feeling of support.
4. The challenges with doing exercises regularly for 6 months.How have we shared these results?
• On our website – https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.plymouth.ac.uk%252Fresearch%252Femapp-trial%2FNBTI%2FOjK-AQ%2FAQ%2Fafe423e4-51a2-483f-8744-09ba40443395%2F1%2FspuLUacLAv&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7C56136733a7cc482b10c108ddd9bb3d3c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638906120396531509%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=JwKDCPfpKG1UVeF8SwrivcX5ius%2FzqRnpah8nxFaiOU%3D&reserved=0
• Feedback sessions for participants
• Feedback to the physiotherapists and NHS trusts involved in the trial
• Social media platforms
• Presentation of results at scientific conferences
• Research paper publications
• Report to funding body – National Institute for Health Research (NIHR)Thank you to everyone who participated in this study!
This study was funded by the NIHR RfPB programme.
The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
NOTE - This summary has been made publicly available on: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.plymouth.ac.uk%252Fresearch%252Femapp-trial%2FNBTI%2FOjK-AQ%2FAQ%2Fafe423e4-51a2-483f-8744-09ba40443395%2F1%2FspuLUacLAv&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7C56136733a7cc482b10c108ddd9bb3d3c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638906120396546308%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=uK%2FAKd9R6XBJZ1e5AgU1y67h%2Bn9GoFnLQlOE%2BU%2Fu2hY%3D&reserved=0
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0155
Date of REC Opinion
14 Jul 2021
REC opinion
Further Information Favourable Opinion