title: Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial.
abstract: BACKGROUND
  About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care.
  
  
  METHODS
  This study will be a four-parallel-arm, multicentre, randomised, placebo-controlled trial. A total of 212 pregnant women (24 to 36 weeks' gestation), aged at least 17 years, with LBPGP, will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group (VAAc), to the non-specific auricular acupuncture plus standard obstetric care group (NSAAc), to the non-specific placebo auricular acupuncture plus standard obstetric care group (PAAc), or the standard obstetric care group (SOC). The VAAc, NSAAc, and PAAc groups will receive treatment at three auricular acupuncture points (specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups), once a week for 2 weeks; the SOC group will receive only standard obstetric care during the same period. The primary outcome will be the reduction in pain intensity, according to the visual analogue scale (iVAS), at 2 weeks after the start of treatment. The secondary outcomes will be functional status with respect to LBPGP (according to the Roland-Morris disability questionnaire), health-related quality of life (SF12) at 2 weeks after the start of treatment, and iVAS at 12 and 48 weeks postpartum.
  
  
  CONCLUSIONS
  This trial will implement a high-quality methodology and may provide evidence for the efficacy, safety, and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN41033073 (date 20/03/2014).
authors.affiliation: Pain Treatment Unit, Doña Mercedes Primary Health Care Centre, Segovia s/n, Dos Hermanas 41701, Spain. jorgef.vas.sspa@juntadeandalucia.es.
authors.forename: Jorge
authors.initials: J
authors.lastname: Vas
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Aranda-Regules
authors.forename: Manuela
authors.initials: M
authors.lastname: Modesto
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Aguilar
authors.forename: Mercedes
authors.initials: M
authors.lastname: Barón-Crespo
authors.forename: María
authors.initials: M
authors.lastname: Ramos-Monserrat
authors.forename: Manuel
authors.initials: M
authors.lastname: Quevedo-Carrasco
authors.forename: Francisco
authors.initials: F
authors.lastname: Rivas-Ruiz
mesh_terms: D015669:Acupuncture Points; D020831:Acupuncture, Ear; D002985:Clinical Protocols; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000628:therapy*; D010147:Pain Measurement; D017699:Pelvic Pain / Q000175:diagnosis / Q000628:therapy*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000628:therapy*; D011320:Primary Health Care; D011788:Quality of Life; D012107:Research Design; D013030:Spain; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome