Cameron, L

Carter, K

Chatfield, S

Freeman, Jennifer

Halliday, Bradley

Hawton, A

Hayward, C

Hosking, J

Shawe, J

English

Halliday, B

Freeman, J

Plymouth Electronic Archive and Research Library

University of PlymouthPEARL https://pearl.plymouth.ac.ukFaculty of Health: Medicine, Dentistry and Human Sciences School of Health Professions2023-09-20Bradley Halliday, Sarah Chatfield, Lee Cameron, Joanne Hosking, Jill Shawe, Annie Hawton, Chris Hayward, Kirsty Carter, Jade Chynoweth, Lauren Stockley, Matthew Bailey, Jennifer FreemanBackgroundPost-partum pelvic girdle pain (PPGP), experienced by approximately 10% of women, is typically refractory to conservative management. Customised dynamic elastomeric fabric orthoses (DEFO’s) are one novel option to address this. AimsAssess the feasibility and acceptability of an anticipated randomised controlled trial (RCT) study comparing a DEFO plus standardised advice/exercises (Intervention) versus standardised advice/exercise alone (Control). 3) Outcome measure completion at 24 weeksResults: Quantitative2) Adherence to the intervention6) Adverse Events4) Signal of efficacy at 24 weeks Five adverse eventsIntervention group • 3 - (x2 thrush, x1 vulval cyst –present prior to intervention)Control• 1 Serious Adverse Event (SAE)-Scarlet FeverNumerical Pain Rating Scale change (primary outcome measure) Between group difference80% CIWorst level in the day (0 - 10) -0.68 [-2.14, 0.78]Average level in the day (0 – 10) 0.13 [-1.07, 1.32]• Criteria set for minimum wear time indicating adherence: 42 hours/week • No participants met the wear time adherence criteria • No pattern was evident in terms of wear time and pain levels• Fig 2 shows the wear-time and pain profile for an individual participant as an example of available data. Shaded red area indicates period of data loss.1) Acceptability of trial methods• Positive views on web-based app for data collection.• Participants would like a hybrid approach to intervention delivery, with one session in-person (probably the first). Clinicians expressed a clear preference for all in-person sessions.Evaluating the Management of chronic Pelvic girdle pain following Pregnancy (EMaPP): A randomised controlled feasibility trialThis project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR201930). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.Intervention:Standardised AdviceProtocolised ExercisesDEFO Control:Standardised advice Protocolised exercises  • Target for recruitment = 60 within 7-month window • Actual recruitment =  24 (40% of target)2) Intervention acceptability • Shorts were acceptable but not in hot weather. 3) Impact of DEFO• “Held me together”• Confidence and support to be more physically active. • Increased awareness of movement ability.4) Adherence to exercise • Struggled to maintain adherence.• Identified barriers (lack of therapist contact) and facilitators (family support).Results: QualitativeVariable Outcome (% of those randomised)Primary outcome measure completion (NRPS) 95%% completing secondary outcome measures 89-95%Fig. 1 Flow of participants through the study 1) RecruitmentFig. 2 Orthotimer and NPRS data  ConclusionFeasibility of a future RCT was not demonstrated in its current format; low recruitment rate was the key barrier despite varied and intensive efforts to recruit participants. Technical issues that caused significant Orthotimer missing data are resolvable. Trial procedures/interventions were acceptable.  Understanding how best to engage women in this research is needed before a definitive trial is undertaken.Methods• Design: Multicentre feasibility RCT with embedded qualitative study and economic evaluation.• Procedures: Participants randomised to receive two physiotherapy sessions [Intervention/Control] remotely, separated by 14 days.• Outcome measures: Remotely completed via a web-based app. All measures self-report. • Proposed primary outcome measure for definitive trial: Numerical Pain Rating Scale (NPRS) assessed pain intensity fortnightly over 24 weeks. • Secondary outcomes: Secondary measures assessed kinesiophobia, continence, function, quality of life and depression at baseline, 12 and 24 weeks. Wear time adherence measured by an Orthotimer. Adverse events recorded.5) Health Economics • Data completeness of Resource Use Questionnaire and EQ-5D-5L at 24 weeks was 75% Health State Utility Values (summary statistics)Intervention Controln / Mean (SD) [range]n / Mean (SD) [range]EQ-5D-5L Baseline n=11 / 0.627 (0.124)[0.496, 0.871]n=13 / 0.590 (0.183)[0.025, 0.733]24 weeks n=9 / 0.744 (0.135)[0.460, 0.871]n=9 / 0.678 (0.218) [0.138, 0.868]Quality adjusted life years (QALYS) – Baseline to 24 weeks Intervention Controln / Mean (SD) [range] n / Mean (SD) [range]EQ-5D-5L n= 9 / 0.322 (0.049) [0.225, 0.402]n= 9 / 0.284 (0.098) [0.038, 0.370]Acknowledgments: Carol Lunn (Trial administrator)

EVALUATING THE MANAGEMENT OF CHRONIC PELVIC GIRDLE PAIN FOLLOWING
PREGNANCY (EMAPP): A RANDOMISED CONTROLLED FEASIBILITY TRIAL

https://pearl.plymouth.ac.uk/bitstream/10026.1/21627/4/EMaPP%20results%20poster.pdf

EVALUATING THE MANAGEMENT OF CHRONIC PELVIC GIRDLE PAIN FOLLOWING PREGNANCY (EMAPP): A RANDOMISED CONTROLLED FEASIBILITY TRIAL

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