Evaluating the Management of Chronic Pelvic Girdle Pain
CompletedNot applicableNCT04981418
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Evaluating the Management of Chronic Pelvic Girdle Pain Following Pregnancy (EMaPP): A Randomised Controlled Feasibility Trial
- Conditions
- Pelvic Girdle Pain
- Interventions
- Device: customised pelvic support shorts
- Other: Exercise
- Other: advice
- Sponsor
- University of Plymouth
- Collaborators
- Royal Cornwall Hospitals Trust; University Hospital Plymouth NHS Trust
- Start date
- 2021-10-04
- Primary completion
- 2023-02-04
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04981418