Management of Chronic Post-Partum Pelvic Girdle Pain Study
CompletedNot applicableNCT02648607
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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)
Pelvic Girdle Pain (PGP) during pregnancy occurs in approximately 70% of females and 38% of women continue to suffer PGP symptoms beyond 12 weeks following delivery. PGP post- partum causes pain during everyday activities that impacts negatively on health related quality of life and is associated with significant healthcare and societal costs. These women are often referred to physiotherapy, however management is difficult and there is a weak evidence base for its management. Alongside the provision of advice and information, physiotherapists commonly prescribe orthoses such as a rigid belt with the aim of optimising pelvic stability and reducing pain. More recently a novel customised Dynamic Elastomeric Fabric Orthosis has been developed as an alternative to an 'off the shelf' pelvic belt. No studies have investigated their effectiveness in complementing standard physiotherapy advice and management. The investigators will undertake a comprehensive systematic review of the literature to critically evaluate the evidence base for the conservative management of chronic post-partum PGP. This will inform a single case experimental design. Here eight AB single case studies will be performed with the point of intervention being randomised between subjects. The use of a randomisation test permits subsequent statistical analyses of group effects. Participants' pain, activity levels, and quality of life will be evaluated along with subjective changes in confidence and urinary incontinence. Adherence to orthosis use will be diarised. Exit interviews will assess aspects such as the appropriateness of the outcome measures and acceptability of the intervention that will help to inform future clinical trials.
Study details
- Official title
- Management of Chronic Post-Partum Pelvic Girdle Pain Study: Evaluating Effectiveness of Combined Physiotherapy and a Dynamic Elastomeric Fabric Orthosis
- Conditions
- Pelvic Girdle Pain
- Symphysis Pubis Dysfunction
- Interventions
- Device: Customised Dynamic Elastomeric Fabric Orthosis (DEFO)
- Sponsor
- University of Plymouth
- Start date
- 2016-01
- Primary completion
- 2017-07
- Sex
- Female
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Women with PGP (commenced or aggravated during pregnancy) will be included if they: * have symptoms that continued for \> 3 months following birth, * have PGP that causes walking and/or stair climbing to be bothersome (as determined by a score of at least 2 on a 10 point visual analogue scale) * are positive on at least 3 out of 7 pain provocation tests (see screening section below) Exclusion Criteria: Women will be excluded if they have: * A recent history/signs or symptoms indicative of serious causes of pain that might be inflammatory infective, traumatic, neoplastic, degenerative or metabolic. In particular exclusion will occur if following questioning or clinical examination there is evidence of: * trauma * Indicators of serious pathology * steroid use * drug abuse * HIV infection * immunosuppressed state * neurological symptoms/signs (including cauda-equina) * fever * systemically unwell * obstetric complications * pain that does not improve with rest/severe disabling pain * history of chronic back or pelvic pain requiring surgery. * a known skin allergy to Lycra
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02648607