PMID- 25027493
OWN - NLM
STAT- MEDLINE
DCOM- 20150331
LR  - 20211021
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 15
DP  - 2014 Jul 16
TI  - 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.
PG  - 288
LID - 10.1186/1745-6215-15-288 [doi]
AB  - 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 AND DESIGN: 
      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. DISCUSSION: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41033073 (date 
      20/03/2014).
FAU - Vas, Jorge
AU  - Vas J
AD  - Pain Treatment Unit, Dona Mercedes Primary Health Care Centre, Segovia s/n, Dos 
      Hermanas 41701, Spain. jorgef.vas.sspa@juntadeandalucia.es.
FAU - Aranda-Regules, Jose Manuel
AU  - Aranda-Regules JM
FAU - Modesto, Manuela
AU  - Modesto M
FAU - Aguilar, Inmaculada
AU  - Aguilar I
FAU - Baron-Crespo, Mercedes
AU  - Baron-Crespo M
FAU - Ramos-Monserrat, Maria
AU  - Ramos-Monserrat M
FAU - Quevedo-Carrasco, Manuel
AU  - Quevedo-Carrasco M
FAU - Rivas-Ruiz, Francisco
AU  - Rivas-Ruiz F
LA  - eng
SI  - ISRCTN/ISRCTN41033073
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140716
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Acupuncture Points
MH  - *Acupuncture, Ear
MH  - Clinical Protocols
MH  - Disability Evaluation
MH  - Female
MH  - Humans
MH  - Low Back Pain/diagnosis/*therapy
MH  - Pain Measurement
MH  - Pelvic Pain/diagnosis/*therapy
MH  - Pregnancy
MH  - Pregnancy Complications/diagnosis/*therapy
MH  - *Primary Health Care
MH  - Quality of Life
MH  - *Research Design
MH  - Spain
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC4223527
EDAT- 2014/07/17 06:00
MHDA- 2015/04/01 06:00
PMCR- 2014/07/16
CRDT- 2014/07/17 06:00
PHST- 2014/05/13 00:00 [received]
PHST- 2014/07/01 00:00 [accepted]
PHST- 2014/07/17 06:00 [entrez]
PHST- 2014/07/17 06:00 [pubmed]
PHST- 2015/04/01 06:00 [medline]
PHST- 2014/07/16 00:00 [pmc-release]
AID - 1745-6215-15-288 [pii]
AID - 10.1186/1745-6215-15-288 [doi]
PST - epublish
SO  - Trials. 2014 Jul 16;15:288. doi: 10.1186/1745-6215-15-288.