title: A randomised non-inferiority controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour.
abstract: BACKGROUND
  Almost one third of women suffer continuous lower back pain during labour. Evidence from three systematic reviews demonstrates that sterile water injections (SWI) provide statistically and clinically significant pain relief in women experiencing continuous lower back pain during labour. The most effective technique to administer SWI is yet to be determined. Therefore, the aim of this study is to determine if the single injection SWI technique is no less effective than the routinely used four injection SWI method in reducing continuous lower back pain during labour.
  
  
  METHODS
  The trial protocol was developed in consultation with an interdisciplinary team of clinical researchers. We aim to recruit 319 women presenting at term, seeking analgesia for continuous severe lower back pain during labour. Participants will be recruited from two major maternity hospitals in Australia. Randomised participants are allocated to receive a four or single intradermal needle SWI technique. The primary outcome is the change in self-reported pain measured by visual analogue scale at baseline and thirty minutes post intervention. Secondary outcomes include VAS change scores at 10, 60, 90 and 120 min, analgesia use, mode of birth and maternal satisfaction.
  
  
  METHODS
  Sample size was calculated to achieve 90% power at an alpha of 0.025 to detect a non-inferiority margin of ≤1 cm on the VAS, using a one-sided, two-sample t-test. Baseline demographic and clinical characteristics will be analysed for comparability between groups. Differences in primary (VAS pain score) and secondary outcomes between groups will be analysed by intention to treat and per protocol analysis using Student's t-test and ANOVA.
  
  
  CONCLUSIONS
  This study will determine if a single intradermal SWI technique is no less effective than the routinely used four injection technique for lower back pain during labour. The findings will allow midwives to offer women requesting SWI during labour an evidence-based alternative technique more easily administered by staff and accepted by labouring women.
  
  
  BACKGROUND
  ACTRN12609000964213.
authors.affiliation: Mater Health Services, South Brisbane, Qld, 4101 Australia. nigel.lee@mater.org.au
authors.forename: Nigel
authors.initials: N
authors.lastname: Lee
authors.forename: Peter
authors.initials: P
authors.lastname: Coxeter
authors.forename: Michael
authors.initials: M
authors.lastname: Beckmann
authors.forename: Joan
authors.initials: J
authors.lastname: Webster
authors.forename: Vanessa
authors.initials: V
authors.lastname: Wright
authors.forename: Tric
authors.initials: T
authors.lastname: Smith
authors.forename: Sue
authors.initials: S
authors.lastname: Kildea
mesh_terms: D016362:Analgesia, Obstetrical / Q000379:methods*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D007271:Injections, Intradermal / Q000379:methods; D048949:Labor Pain / Q000628:therapy*; D017116:Low Back Pain / Q000628:therapy*; D010147:Pain Measurement; D011247:Pregnancy; D016037:Single-Blind Method; D014867:Water / Q000008:administration & dosage*
chemical_list: D014867:Water