Evaluating the use of support shorts to manage chronic pelvic girdle pain in women following pregnancy

INTERVENTION: The eventual aim is to undertake a large, multi‐centre, assessor‐blinded randomised controlled trial (RCT) asking the research question “What is the clinical and cost‐effectiveness of pelvic support shorts plus standardised information and exercises versus standardised information and exercises alone in women with chronic, severe pregnancy‐related pelvic girdle pain?” Before moving to a definitive trial there are a number of uncertainties that need addressing. This randomised controlled feasibility trial aims to clarify these uncertainties by obtaining the data and operational experience necessary to inform the conduct and finalise the design of the definitive trial. Its design and methodology therefore purposefully reflects that which we anticipate would be the future definitive trial. This is summarised in detail below. OVERVIEW The researchers will undertake a multi‐centre feasibility RCT, randomising participants to receive either the “pelvic support shorts” plus standardised information and exercises (intervention) or standardised information and exercises alone (control). They will recruit 60 women from the South West of England who are experiencing chronic (=3 months) and severe pelvic girdle pain following pregnancy. Following screening and consent, baseline assessment will be undertaken using a range of patient‐reported measures: pain, depression, continence, function, quality of life, health/social care and patient resource use. Women will be randomly allocated to intervention or control. Two weeks following randomisation, all participants will attend a physiotherapy session via web conference to receive standardised information and suggested exercises. In addition, interventio CONDITION: Chronic pelvic girdle pain following pregnancy ; Pregnancy and Childbirth PRIMARY OUTCOME: Pain intensity in four categories (worst level of pelvic pain during the day, average level of pelvic pain during the day, worst level of pelvic pain during the night, average level of pelvic pain during the night) measured using the Numerical Rating of Pain Scale (NRPS) questionnaire at baseline then fortnightly for 24 weeks INCLUSION CRITERIA: 1. Women aged greater than or equal to 18 years 2. Able and willing to provide informed consent 3. Self‐reported persistent pelvic girdle pain (PGP) (=3 months postpartum) 4. Self‐reported severe PGP (causing walking or stair climbing to be bothersome) 5. Diagnosed with PGP in line with European guidelines 6. PGP must have started or been aggravated during pregnancy, as determined by self report SECONDARY OUTCOME: ; 1. Symptoms and function assessed using the pelvic girdle questionnaire (PGQ) at baseline, 12 and 24 weeks; 2. Quality of life assessed using EQ5D5L at baseline, 12 and 24 weeks; 3. Quality of life assessed using SF36v2 at baseline, 12 and 24 weeks; 4. Incontinence assessed using the International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form (ICIQ‐UI SF) at baseline, 12 and 24 weeks; 5. Depression assessed using the Edinburgh Postnatal Depression Scale (EPDS) at baseline, 12 and 24 weeks; 6. Kinesiophobia/fear of movement assessed using Tamp Scale Kinesiophobia (TSK) at baseline, 12 and 24 weeks; 7. Body perception assessed using Freemantle Back Awareness Questionnaire (FreBAQ) at baseline, 12 and 24 weeks; 8. Resource use assessed using health resource use questionnaire at baseline, 12 and 24 weeks;