Ignite Creation Date:
2024-05-06 @ 8:00 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02648607
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2016-01-06
Brief Title:
Management of Chronic Post-Partum Pelvic Girdle Pain Study
Sponsor:
University of Plymouth
Organization:
University of Plymouth
Study Overview
Official Title:
Management of Chronic Post-Partum Pelvic Girdle Pain Study Evaluating Effectiveness of Combined Physiotherapy and a Dynamic Elastomeric Fabric Orthosis
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOPS
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
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
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
Detailed Description:
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 201213 httpwwwstatisticsgovukhubindexhtml 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 post-partum then urinary incontinence is reported to continue due to an association with PGP and pelvic floor muscle weakness Fitzgerald et al 2012
PGP is difficult to manage with limited guidance from the literature on conservative management European Guidelines recommend exercise prescription for PGP Vleeming et al 2008 leading to the development of a Specialist Womens Health group information booklet that will be used in the current study
An integral part of physiotherapists management approach for PGP is the provision of orthoses such as rigid pelvic belts which aim to improve pelvic joint stability and thus reduce pain Pelvic belts apply forces to the pelvis within the transverse plane Recently dynamic elastomeric fabric orthoses DEFO have been developed A DEFO is made of elastomeric panels eg Lycra that are pre-stretched and can provide forces in multiple directions to the pelvis Thus they provide continued multi-axis support whilst being flexible enough to allow people to participate in everyday activities Studies on sports people with pelvic girdle pain have shown that the application of forces in more than one plane decreases pain and improves function over and above that seen with the application of transverse forces associated with pelvic belts Sawle et al 2013 Therefore the DEFO may have advantages over current rigid pelvic belts in terms of mode of action clinical effectiveness and user satisfaction To date a comprehensive literature search has revealed there have been no trials of orthotic use in women with chronic PGP post-partum This project will therefore follow the recommendations of the Medical Research Council in the development and evaluation of complex interventions to establish a clearer understanding of PGP and its management post-partum that can inform future clinical trials
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 post-partum then urinary incontinence is reported to continue due to an association with PGP and pelvic floor muscle weakness Fitzgerald et al 2012
PGP is difficult to manage with limited guidance from the literature on conservative management European Guidelines recommend exercise prescription for PGP Vleeming et al 2008 leading to the development of a Specialist Womens Health group information booklet that will be used in the current study
An integral part of physiotherapists management approach for PGP is the provision of orthoses such as rigid pelvic belts which aim to improve pelvic joint stability and thus reduce pain Pelvic belts apply forces to the pelvis within the transverse plane Recently dynamic elastomeric fabric orthoses DEFO have been developed A DEFO is made of elastomeric panels eg Lycra that are pre-stretched and can provide forces in multiple directions to the pelvis Thus they provide continued multi-axis support whilst being flexible enough to allow people to participate in everyday activities Studies on sports people with pelvic girdle pain have shown that the application of forces in more than one plane decreases pain and improves function over and above that seen with the application of transverse forces associated with pelvic belts Sawle et al 2013 Therefore the DEFO may have advantages over current rigid pelvic belts in terms of mode of action clinical effectiveness and user satisfaction To date a comprehensive literature search has revealed there have been no trials of orthotic use in women with chronic PGP post-partum This project will therefore follow the recommendations of the Medical Research Council in the development and evaluation of complex interventions to establish a clearer understanding of PGP and its management post-partum that can inform future clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None