EMaPP trial

Welcome to the EMaPP trial. 

This website provides a range of information about the study, which we hope you will find helpful. This page is designed for use by clinicians participating in the trial and those interested in taking part in the EMaPP trial. The content of this website will be kept updated to keep you informed of progress.

Background

Pelvic girdle pain is common during pregnancy. However, for some women it continues for longer than expected after giving birth and can cause difficulty in everyday activities such as walking, rolling in bed, and caring for your child. Rigid pelvic belts are often used to manage this condition but can be uncomfortable to wear. Customised pelvic support shorts, which are made of Lycra material, offer an alternative with the potential for improved comfort and effectiveness.

Our research team has previously tested the support shorts in a randomised controlled trial of women with pelvic girdle pain during pregnancy. The support shorts were more effective than a rigid pelvic belt. Our team have also studied the support shorts in a group of eight women with persistent pelvic girdle pain following pregnancy where we found the shorts showed some promise in improving pain.

We now need to test this in a larger sample to better understand whether these support shorts have promise as an intervention before a much larger national clinical trial is undertaken

What is the EMaPP trial

The EMaPP trial aims find out if wearing customised pelvic support shorts alongside standard physiotherapy care (advice and exercise), demonstrates promise as a treatment in managing persistent pelvic girdle pain in women following childbirth.

It will involve 60 women with pelvic girdle pain following birth. They will be recruited from physiotherapy departments, women’s health services, GP surgeries and via social media forums. Women will be randomly allocated to one of two groups:

  • Group 1 (Standard Physiotherapy care (advice & exercise) + Support shorts
  • Group 2 (standard Physiotherapy care (advice & exercise)

Women will attend two physiotherapy appointments approximately 7-10 days apart and will be involved with the trial for a total of 24 weeks (completing online questionnaire at set time points)

At the end of the trial we would like to understand women’s views on the running of the trial and comfort of the shorts. We will do this through short interviews at the end of the trial with one of the research team.

What is pelvic girdle pain?

Pelvic girdle pain describes pain in the joints that make up your pelvic girdle. The discomfort is often felt over the pubic bone at the front, below your tummy or across one or both sides of your low back.

Who can take part?

To take part you will need to be:

  • aged 18 or over
  • reporting pelvic girdle pain (PGP) for a minimum of 3 months following childbirth
  • reporting PGP causing walking or stair climbing to be bothersome
  • reporting PGP that was started or aggravated during pregnancy.

Your eligibility to take part will be assessed through a number of stages. You will begin by speaking with our research team over the phone to check that you are meeting the above criteria. This will be followed by a teleconference call where you will go through some physical tests with the researcher to check that your pain is coming from the pelvic girdle.

If you are eligible after the telephone and video conference assessments, we will ask for your consent to take part in the study.

Where is the study occurring?

To take part in this study you will need to live in Plymouth. The study is being run through the University Hospitals Plymouth NHS Trust.

We hope to have other locations involved soon. Check back with us regularly as this webpage will be updated.

Are you interested?

We are not yet recruiting participants but will be starting on the 27th September 2021. If you are interested, you can let us know at emapp@plymouth.ac.uk. We will save your details and make contact with you in the near future.

Key study information

Sponsor: Royal Cornwall Hospitals NHS Trust

Ref: NIHR201930

Ethics Ref: 21/WM/0155

IRAS project ID: 297938

ISCRTN reg: ISRCTN67232113

Clinical trial.gov reg: NCT04981418

Funding: National Institute for Health Research (NIHR): Research for patient benefit programme

Study news updates:

Study goes live on the 27/09/21

Participants recruited - 00/60

Contact the EMaPP trial team

University of Plymouth, School of Health Professions, Peninsula Allied Health Centre, Derriford Road, Plymouth PL6 8BH

Patients' guide to remote appointments

Remote appointments have a number of advantages, and we have a guide to provide more information on video-based and telephone appointments for people who experience difficulties with movement, their family members or carers.

Find out more about remote appointments