title: Evaluating acupuncture and standard care for pregnant women with back pain: the EASE Back pilot randomised controlled trial (ISRCTN49955124).
abstract: BACKGROUND
  Low back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are common and often accepted as a 'normal' part of pregnancy. Many women receive little in the way of treatment, and yet pain interferes with sleep, daily activities and work and leads to increasing requests for induction of labour or elective caesarean section. The aim of this study was to assess the feasibility of a full RCT evaluating the benefit of acupuncture for pregnancy-related back pain.
  
  
  METHODS
  This study is a single-centre, three-arm pilot RCT in one large maternity unit and associated antenatal and physiotherapy clinics. Women were eligible if they had pregnancy-related LBP with or without PGP. Exclusions included a history of miscarriage, high risk of early labour or pre-eclampsia, PGP only and previous acupuncture. Interventions were standard care (SC): a self-management booklet with physiotherapy if needed. SC+TA: the booklet and physiotherapy comprising true (penetrating) acupuncture, advice and exercise. SC+NPA: the booklet and physiotherapy comprising non-penetrating acupuncture, advice and exercise. Remote telephone randomisation used a 1:1:1 allocation ratio stratified by gestational weeks. Three measures of pain/function were compared to inform the primary outcome measure in a full RCT: the Pelvic Girdle Questionnaire (PGQ), Oswestry Disability Index (ODI) and 11-point 0-10 numerical rating scale for pain. Analysis focused on process evaluation of recruitment, retention, descriptive information on outcomes, adherence to treatment, occurrence of adverse events and impact of physiotherapist training.
  
  
  RESULTS
  One hundred twenty-five women were randomised (45% of those eligible) between April and October 2013; 73% (n= 91) provided 8-week follow-up data. Three of six recruitment methods accounted for 82% of total uptake: screening questionnaire at the 20-week scan, community midwives issuing study cards, and self-referral following local awareness initiatives. Physiotherapists' self-confidence on managing pregnancy-related LBP improved post training. The PGQ is suitable as the primary outcome in a full trial. The average number of treatment sessions in both SC+TA and SC+NPA was six (in line with treatment protocols). No serious adverse events attributable to the trial treatments were reported.
  
  
  CONCLUSIONS
  A full RCT is feasible and would provide evidence about the effectiveness of acupuncture and inform treatment choices for women with pregnancy-related LBP.
  
  
  BACKGROUND
  ISRCTN49955124.
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Annette
authors.identifier: 0000-0002-9810-7994
authors.initials: A
authors.lastname: Bishop
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Reuben
authors.initials: R
authors.lastname: Ogollah
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Bartlam
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK ; School of Health and Rehabilitation, Keele University, Keele, UK.
authors.forename: Panos
authors.initials: P
authors.lastname: Barlas
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Melanie A
authors.initials: MA
authors.lastname: Holden
authors.affiliation: Birmingham Centre for Women's and Children's Health, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK ; Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
authors.forename: Khaled M
authors.initials: KM
authors.lastname: Ismail
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK ; School of Health and Population Sciences, University of Birmingham, Birmingham, UK ; Health Economics Unit, University of Birmingham, Birmingham, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Jowett
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Martyn
authors.initials: M
authors.lastname: Lewis
authors.affiliation: Manchester Metropolitan University, Manchester, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Lloyd
authors.affiliation: Faculty of Health Sciences, Staffordshire University, Stafford, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Kettle
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK ; School of Health and Population Sciences, University of Birmingham, Birmingham, UK ; Health Economics Unit, University of Birmingham, Birmingham, UK.
authors.forename: Jesse
authors.initials: J
authors.lastname: Kigozi
authors.affiliation: Research Institute for Primary Care & Health Sciences, Keele University, Keele, Staffordshire ST5 5BG UK.
authors.forename: Nadine E
authors.initials: NE
authors.lastname: Foster
keywords: Acupuncture; Low back pain; Pelvic girdle pain; Physiotherapy; Pilot; Pregnancy; RCT