Pelvic Girdle Pain and. The HG Trial

Transcription

1 Pelvic Girdle Pain and The HG Trial

2 Our Story In 2012 whilst pregnant Ruth suffered with Symphysis Pubis Dysfunction (SPD) / Pelvic Girdle Pain (PGP) Started at 16 weeks into the pregnancy By 20 weeks suffering with Severe pain

3 Our Story What is PGP / SPD? Condition which causes pain in any or all of the pelvic joints Timeline of events Suffered with PGP / SPD previous pregnancy Supported by GP and Midwife Physiotherapy Belts / Crutches Self Help home aids / alternative therapy Hospital inpatient bed rest Elective Caesarean emergency caesarean

4 What we were trying to achieve?

5 What was achieved?

6 Factors to be considered Essential to achieve the following Correct Support Comfort using correct Fabric Practical

7 So what next? What next? 1 st - Is it worth pursuing? 2 nd - How do we take this forward? 3 rd Where do we go?

8 Next Step Contact Bangor University Bangor University passed on a name Contacted Dr Kalpana Upadhyay at Wrexham Maelor Hospital (BCHUB) arranged a meeting

9 When it all started happening! Meeting Dr Kalpana Upadhyay - Worth pursuing with the project? Dr Kalpana Upadhyay interested in the device and wanted to explore further 2 nd Meeting set up with Rebecca Burns of Health & Care Research Wales Meeting introduced to Julian Breeze of NWORTH Bangor University. Small team was set up.

10 Support This was completely new territory for ourselves and the guidance and support that was given by Dr Kalpana Upadhyay, Rebecca Burns and Julian Breeze was invaluable!!! Following an application submitted by the above Team - Funding was secured which started the ball rolling for the trials It moved on from there.where Lindsay Ashton who is one of the Lead physiotherapists involved with the trials will continue with the role of BCUHB and how the HG trials started..

11 Physio background First described in 1870 Approximately 50% of ladies will experience some degree of pain during pregnancy No longer considered to be normal aches and pains No longer told to put up with it until baby is born Can vary from mild occasional symptoms to severe pains which affect all aspects of daily life Many theories have suggested reasons for pain such as hormones and joint laxity, to date no reliable evidence exists Doesn t always resolve at the end of pregnancy, 2 years post delivery 9% still experience pain- such as Ruth.

12 Management Wait and see Medication Physiotherapy Task modification Bed rest/admission Early induction of labour

13 Physiotherapy European guidelines Based upon assessment Individually tailored management Varies, no consensus- postcode lottery! Aimed at restoring function, reducing disability, management of pain, supporting muscular adaption, addresses joint flexibility, provides reassurance May include provision of support belt

14 Belts Historically focus of physio input Aim to support weakened muscle system May add to pelvic stability Can reduce pain and inhibition of normal muscle support Improve function and family inclusion Many different designs

15 Collaboration and team building Dafydd and Ruth approached Dr Kalpana Upadhyhay, consultant in Obstetrics & Gynaecology, with the prototype design of the harness. Decision was to test the efficacy of the belt in a clinical trial. Research protocol submitted to R&D and funding granted via the Pathway to Portfolio stream. Team identified and brought together from clinical and professional staff HG trial was launched From humble first meeting the team now comprises just short of 20 personnel

16 HG trial Single blinded randomised controlled trial across BCUHB Inclusion/exclusion criteria Strict methodology Initially as pilot with 60 recruits Data collection to assess impact and effectiveness Analysis with assistance of NWORTH Outcome measures Adverse events

17 Manufacturer/ Sponsor Health and care research Wales THE TEAM BCUHB

18 The team

19 The Team Dr (Mrs) Kalpana Upadhyay (Consultant obstetrician; chief investigator) Mr Dafydd and Mrs Ruth Roberts(Sponsor) Mrs Jan Fereday Smith (Physiotherapy lead) Ms Lynne Grundy Deputy director R&D/midwife) Ms Rebecca Burns (Industry manager HCRW, ) Dr Zoe Hoare & Dr Mohammed Hussain (NWORTH) Statisticians, University of Bangor Ms. Lindsay Ashton, Valerie Fletcher, Sarah Watkins and Fran Hughes (Senior Physiotherapists) Ms. Caroline M Jones, Annette Bolger & Stella Wright (Research Officers) Dr David Parker (Consultant radiologist, independent observer)

20 The future Hope that this research leads to improved management of ladies with PGP through improved awareness, possibly belt design. Add to evidence base for PGP Continue themes of prudent healthcare within NHS, demonstrate cost savings Further collaboration and public and industry involvement with NHS Influence others to consider clinical research and assist streamlining this process New trail facilitator post in R&D for BCUHB

21 Together Everyone Achieves More

22 Start Up The support and Guidance from the Team has been immense Expensive process but is made more achievable with guidance and collaboration On a commercial aspect we are aware that the results of the Trials could be negative and it may no show any benefit! Until we try we don't know this what the collaboration has allowed us to do! Not knowing where to go the NHS is such a big organisation whey wouldn t wont to entertain us Take this opportunity to thank all involved each and everyone has been so helpful and supportive of the and especially would like to mention Dr Kalpana Upadhyay, Rebecca Burns, BCUHB R&D dept and Lindsay Ashton for all their hard work

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