Download pelvic girdle pain

Introducing
The
HG TRIAL
Management of Pelvic Girdle
Pain in Pregnancy using
Harness Gravidarum
A New Trial to test
out a new Innovation!
• In response to his wife’s pelvic pain in pregnancy, a man from
Anglesey - Dafydd Roberts, designed and produced a harness
specifically to tackle this common but sometimes debilitating
problem.
• Dafydd is hopeful this harness can improve the discomfort
experienced by many women in pregnancy due to pelvic girdle
pain.
• The only way to find out how effective this harness may be is to do a
clinical trial!
• Dafydd teamed up with Consultant Obstetrician Kalpana Upadhyay
to plan this trial.
• Application for funding approved via Pathway to Portfolio pathway.
Background
• Nearly 20% of pregnant women experience pelvic girdle pain during
pregnancy which can be back pain, pubic pain or pain in all the
pelvic joints.
• Of these women, 2.3% experience severe anterior or Symphysis
Pubic pain.
• Despite such high incidence, this is much under researched area in
obstetrics with no high quality evidence to suggest the best
treatment.
• Current treatments include analgesics, physiotherapy, support belts
and acupuncture.
• No studies in literature involving a support device including all the
joints of the pelvis.
• The new device – ‘Harness Gravidarum’ is designed to ease all
types of pelvic pain and even lower back discomfort.
Current management of
PGP in BCUHB
• Variable at the three sites.
• Community midwives, obstetricians and occasionally
GPs see women who complain of PGP.
• The treatments offered include physiotherapy,
analgesics, acupuncture, lifestyle modification, and
pelvic support belts or braces.
• Different belts offered at different sites. (No belts in
East)
• The belts given may or may not be designed for use in
pregnancy.
Pt presents reporting Pregnancy related
Pelvic, lower back or hip pain
Pregnancy related PGP is a manageable condition
Less than 12/40
1. Provide Leaflet
2. Advice re;
Condition
Reassurance
Risk factors
Pain relief
Posture
Work
Weight
12-32/40
Greater than 32/40
Provide Leaflet and Advice as
with
Early phase.
if
No improvement with advice
and high pain score (VAS
7+/10)
and / or
Refer to physio if
clinically indicated
if
or
Severely
limited mobility
and may require
walking aid.
Physio
referral
indicated if
severely
affected
(Admission
prevention)
Onset in first 12/52 and not
well managed.
and / or
Pre/previous pregnancy back,
hip, SIJ problems.
Refer to Physiotherapy to assess for elements
of condition suitable for intervention
Assessment and Management plan as
indicated
Unsatisfactory outcome
Refer back
Satisfactory outcome
Discharge
Provide
Advice as
with other
phases
Demonstration of
Harness on Model
Aim
To study the effectiveness of a special
flexible harness in women with Pelvic
Girdle Pain associated with changes in the
measurement of pain severity, physical
activity and improvement in quality of life
compared to the standard treatment for
this condition.
Design
• A single blinded two arm, randomised (1:1)
controlled trial across the maternity units in
BCUHB.
• Recruitment will be from the pregnant women
who have been referred for physiotherapy by the
community midwife or obstetrician.
Inclusion/Exclusion criteria
INCLUSION CRITERIA
EXCLUSION CRITERIA
1. Pregnant women between 20
and 36 weeks of pregnancy
1.
2. Have experienced pelvic
girdle pain for at least two
previous week
Women with known high
risk pregnancy for example
placenta praevia
2.
A history of major systemic
bone disease
3.
History of significant back
or pelvic injury in past
4.
Women on long term
steroid medication
3. Have been given general
information and advice on
pelvic girdle pain in
pregnancy
4. Have tried analgesics and
physiotherapy without
significant relief of symptoms
Methodology
• A written informed consent will be obtained.
• A set of baseline questionnaires will be completed:
Pain intensity - visual analogue score (VAS),
Pelvic Girdle Questionnaire (PGP),
Modified Oswestry Disability Questionnaire (MODQ)
Satisfaction with life scale (SWLS)
• Participants will be randomised (web based randomisation) to the intervention
(Harness Gravidarum) or to the control group (standard lumbar belts)
• Weekly phone calls to the participants for the next four weeks to monitor
progress.
• A physical follow up visit with Physiotherapist after 4 weeks of intervention
• Further follow up at 3 and 6 months post delivery.
Sample Size
• Initial pilot consisting of 60 women (20 at each
site of BCUHB) to look at suitability of outcome
measures and overall feasibility of trial. The final
RCT sample size after data collection from the
pilot.
• Further grant to assess health economics and
potential savings to the NHS by evaluating
reduced rates of induction of labour and
subsequent caesarean sections if effectiveness of
harness is demonstrated.
Data Collection & Management
Data from CRF and Questionnaires will be
recorded on SPSS spreadsheet for
statistical analysis.
Regular monitoring of data by Chief
Investigator and co investigators.
Independent NHS expert for oversight on
data monitoring issues.
Statistical Analysis
SPSS dataset.
Univariate and multivariate analyses will be done.
Descriptive statistics and tests on measures for
pain severity, pain duration, physical activity and
quality of life.
Comparison analysis will be done on ‘Intention to
treat’ basis.
Point estimates and 95% confidence intervals will
be presented for all outcomes.
Main Outcome Measures
Primary outcome
• Improvement in pain severity
and physical activity as
assessed by changes in the
pain scores and disability
index in each group.
Secondary outcome
• Overall improvement in
quality of life as assessed by
the SLWS scores. Use of
adjuncts to treatment like
analgesics would also be
considered as secondary
outcome.
Adverse events during study
• CE marked device.
• Participants instructed to contact CI at any
time after randomisation if any
complications develop.
• All Serious Adverse Events (SAE) or
Serious Adverse Device Events (SADE)
would be investigated in line with BCUHB
R&D policy
The Team
• Dr (Mrs) Kalpana Upadhyay (Chief Investigator)
• Mr Dafydd Roberts (Sponsor)
• Mrs Jan Fereday Smith (Co Investigator)
• Ms Lynne Grundy (Co Investigator)
• Ms Rebecca Burns (Trial Facilitator)
• Dr Zoe Hoare & Dr Mohammed Hussein (NWORTH) – Statisticians, University
of Bangor
• Ms. Lindsay Ashton, Valerie Fletcher, Sarah Watkins (Senior Physiotherapists)
• Ms. Caroline M Jones, Annette Bolger & Stella Wright (Research Officers)
• Dr David Parker (Independent Oversight)
Acknowledgements
• Ms Sarah Davies (Research Midwife, BCUHB)
• Mr Julian Breeze (Portfolio Development
Officer, Bangor University)
• R&D department BCUHB