CompletedNot Applicable

Evaluating the Management of Chronic Pelvic Girdle Pain

United Kingdom24 participantsStarted 2021-10-04

Plain-language 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. The investigators 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women aged greater than or equal to 18 * Able and willing to provide informed consent * Self reported Persistent pelvic girdle pain (PGP) (≥3 months post partum) * Self reported severe PGP (causing walking or stair climbing to be bothersome) * Diagnosed with PGP in line with European guidelines * PGP must have started or been aggravated during pregnancy, as determined by self report Exclusion Criteria: * known allergy to lycra * age \< 18 * currently pregnant * PGP for \> 2 years post partum * Self reported history of pathologies causative of lumbo pelvic pain(e.g. Infection, trauma, cancer) * Participating in concurrent interventional research which may over-burden the patient or confound data collection * There are no special arrangements made for participants who are unable to adequately understand verbal and/or written English. There is no intention to exclude patients, therefore, if they have regular access to a friend or family member who is able to translate for them they would be able to participate * Participants who lack capacity to provide informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline pain intensity (Numerical Rating Pain Scale) at 24 weeks

Timeframe: up to 24 weeks

Trial details

NCT IDNCT04981418

SponsorUniversity of Plymouth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-04

View on ClinicalTrials.gov More Pelvic Girdle Pain trials