Evaluating the Management of Chronic Pelvic Girdle Pain

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.

Conditions

• Pelvic Girdle Pain

Interventions

DEVICE

customised pelvic support shorts

These apply targeted compressive forces to the pelvic girdle through selective precisely positioned reinforced lycra panels that aim to stabilize and align body segments to improve function and reduce unwanted movements. The construction material (Nylon and Elastane) is durable and breathable, and its mechanical properties enable it to provide "dynamic" stability and support (rather than the rigid support provided by "off-the-shelf" belts) during movement/functional activities. This aims to optimise comfort and movement to increase wear compliance, which is crucial as any benefits gained rely upon this.

OTHER

Exercise

Women will be provided with up to a maximum of 4 exercises from a pre-defined list of exercises. Suggested dosages are referred to in the protocol. The exercise programme contains a range of exercise focused around the pelvic girdle and hips (including movement control and strengthening

OTHER

advice

standardised advice on management of pelvic girdle pain, through a discussion centred around 'Guidance for Mothers-to-be and New Mothers: Pregnancy-related Pelvic Girdle Pain' booklet (https://pogp.csp.org.uk/system/files/pogp-pgppat\_3.pdf). This publicly available, specialist physiotherapy approved, standardised leaflet, provides information reflective of current best practice. The participant can use this as an ongoing resource.

Sponsors & Collaborators

• Royal Cornwall Hospitals Trust

  collaborator OTHER

• University Hospital Plymouth NHS Trust

  collaborator OTHER

• University of Plymouth

  lead OTHER

Principal Investigators

• Jennifer Freeman, PhD · University of Plymouth

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-04

Primary Completion

2023-02-04

Completion

2023-02-04

Countries

• United Kingdom

Study Locations