Evaluating acupuncture and standard care for pregnant women with back pain: the EASE Back pilot randomised controlled trial (ISRCTN49955124).

Annette Bishop,Nadine E Foster,Jesse Kigozi,Christine Kettle,Panos Barlas,Alison Lloyd,Bernadette Bartlam,Melanie A Holden,Sue Jowett,Khaled M Ismail,Martyn Lewis,Reuben Ogollah

doi:10.1186/s40814-016-0107-6

Abstract

BackgroundLow 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.MethodsThis 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.ResultsOne 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.ConclusionsA full RCT is feasible and would provide evidence about the effectiveness of acupuncture and inform treatment choices for women with pregnancy-related LBP.Trial registration ISRCTN49955124

Highlights

Low back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are common and often accepted as a ‘normal’ part of pregnancy
This paper reports a pilot randomised controlled trial (RCT) to test the feasibility of a future, full trial to evaluate the effectiveness of adding acupuncture to standard care (SC) for pregnancy-related LBP
Of 388 women assessed for eligibility over the 27-week recruitment period (April to October 2013), 108 did not meet the eligibility criteria

Summary

Introduction

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. Pregnancy-related back pain Low back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are common. Whilst they can occur separately, many women experience both. Studies have shown that women with pregnancy-related LBP have lower quality of life compared with non-pregnant healthy women [6], and reports suggest that 20 to 23% of women take sick leave because of their pain [2]. Pregnancy-related LBP increases with advancing pregnancy, is usually worse at night and interferes with sleep, daily activities and work [4]. An increasing number of affected women request induction of labour or elective caesarean section before the recommended 39th week of gestation [7]

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