Evaluating the Management of Chronic Pelvic Girdle Pain

NCT04981418 | Completed DMC

• 1 other identifier: 297938
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Numerical pain rating scale. This is to assess pain levels across the course of the study period of 24 weeks. Women will be asked to rate their pain experience over the past fortnight, using the NPRS, in four categories: * Worst level of pelvic pain during the day * Average level of pelvic pain during the day * Worst level of pelvic pain during the night * Average level of pelvic pain during the night Scale runs between 0-10. Higher scores represent greater pain intensity.

  up to 24 weeks

Secondary Outcomes (7)

• Pelvic girdle questionnaire

  Baseline, 12 weeks, 24 weeks

• EQ-5D-5L

  Baseline, 12 weeks, 24 weeks

• SF36

  Baseline, 12 weeks, 24 weeks

• EPDS

  Baseline, 12 weeks, 24 weeks

• iciq-ui sf

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

will receive 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. The physiotherapist will teach participants a standardised programme of exercises, typical of those provided within usual physiotherapy practice. Written explanation/illustrations of these exercises will be provided and the women asked to undertake these at home, three times/week.

Other: Exercise; Other: advice

Intervention group

EXPERIMENTAL

In addition to the control groups intervention of exercise and advice, women in the intervention group will be fitted with the customised pelvic support shorts (DM Orthotics Ltd, https://www.dmorthotics.com). Prior to the first physiotherapy session, those women allocated to the intervention group will have recieved the support shorts in the post together with standardised written information on wear time/washing. At the first physiotherapy session (one hour), the woman will be asked to try them on so that the physiotherapist can review the fit and comfort of the shorts. The physiotherapist will reinforce the written advice about wear time and care of the shorts, and answer any queries / brainstorm any issues. At session two (30 minutes), \~10 days later, the physiotherapist will review the fit and wearing of the shorts, problem solve any issues that have arisen, and review exercises to ensure they are being performed correctly.

Device: customised pelvic support shorts; Other: Exercise; Other: advice

Interventions

customised pelvic support shorts DEVICE

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.

Also known as: DEFO, ORTHOTIC

Intervention group

Exercise OTHER

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

Control group; Intervention group

advice OTHER

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.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women only. This study is investigating pregnancy related pelvic girdle pain. The participants will need to have self reported PGP and therefore be female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Plymouth: lead
• Royal Cornwall Hospitals Trust: collaborator
• University Hospital Plymouth NHS Trust: collaborator

Study Sites (1)

University Hospitals Plymouth NHS Trust, Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Orthotic Devices; Exercise; Counseling

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer Freeman, PhD

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All outcomes measures are collected via self report means. This will enable the investigators to be blinded to the outcomes measures reported. Treating clinicians are also blinded to the outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching and research associate

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 29, 2021
• Study Start: October 4, 2021
• Primary Completion: February 4, 2023
• Study Completion: February 4, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Academic paper to be written on completion of trial. Expected completion May 2022

Locations

GB (1)