Clinical Trial: Management of Chronic Post-Partum Pelvic Girdle Pain Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Management of Chronic Post-Partum Pelvic Girdle Pain Study: Evaluating Effectiveness of Combined Physiotherapy and a Dynamic Elastomeric Fabric Orthoses

Brief Summary:

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.

We 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.


Detailed Summary:

Pelvic girdle pain (PGP) occurs in 70% of pregnant women; of whom 25% have severe pain and 8% severe disability requiring the use of crutches, wheelchair or confinement to bed (Wu et al, 2004). At a personal level, women with PGP find that everyday activities such as turning in bed, prolonged walking, or carrying items may cause pain; impacting negatively on quality of life (Wang et al, 2004). In economic terms societal costs are significant, mainly as a consequence of work absenteeism; with 20% of people requiring an average of 7 weeks sick leave (Noren et al, 1997). The impact of this problem is significant; with 812, 970 deliveries occurring throughout the UK in 2012/13 (http://www.statistics.gov.uk/hub/index.html). Pregnancy related PGP has also been documented to increase.

PGP during pregnancy is thought to occur due to increased pelvic joint motion as a consequence of hormonal and biomechanical factors. For many women PGP symptoms resolve within approximately 3 months of delivery, however, approximately 38% of females continue to experience pain beyond 3 months following delivery (Gutke et al 2010, Van de Pol et al 2006). It is unknown why chronic symptoms persist, but age, parity, pre- pregnancy body mass index (BMI), mode of delivery and previous PGP, along with emotional and psychosocial factors have been identified as risk factors associated with chronic PGP (Robinson et al, 2010)). Further, women having caesarean section are at increased risk of post-partum chronic PGP, which is noteworthy given the increasing percentage of women who are electing for caesarean section for early symptomatic relief of peri-partum PGP. Urinary incontinence is also documented to affect approximately 70% of females suffering with pregnancy related PGP. If PGP symptoms continue into the postpartum then urinary incontinence is reported to continue due to an association with PGP and pe
Sponsor: University of Plymouth

Current Primary Outcome: Pain Levels [ Time Frame: Baseline (Pre intervention), 1 weekly intervals for 8, 9, 10 weeks (dependent on baseline randomisation), then a following 8,9,10 weeks Intervention (total 16 weeks) ]

Change in pain levels at 1 weekly intervals will be measured by a self-report numerical pain rating scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Activity Levels [ Time Frame: Baseline (Pre intervention), 1 weekly intervals for 8, 9, 10 weeks (dependent on baseline randomisation), then a following 8,9,10 weeks Intervention (total 16 weeks) ]
    Change in activity levels at 1 weekly intervals will be measured by a self-report questionnaire
  • Quality if Life [ Time Frame: Baseline (Pre intervention), 1 weekly intervals for 8, 9, 10 weeks (dependent on baseline randomisation), then a following 8,9,10 weeks Intervention (total 16 weeks) ]
    Change in quality of life levels at 1 weekly intervals will be measured by a self-report questionnaire


Original Secondary Outcome: Same as current

Information By: University of Plymouth

Dates:
Date Received: January 6, 2016
Date Started: January 2016
Date Completion: January 2017
Last Updated: January 6, 2016
Last Verified: January 2016