INTRODUCTION: Ear acupuncture carried out in primary care by trained midwives, with no specialist training in acupuncture, may be effective in alleviating pregnancy-related lower back and/or posterior pelvic girdle pain (LBPGP). The objective of this study was to assess the effect of ear acupuncture associated with standard obstetric care, in the primary care setting, on LBPGP experienced by pregnant women. MATERIAL AND METHODS: This four-group, multicentre, randomised controlled trial was conducted at 18 public primary care centres in three regions in Spain, with the participation of 220 pregnant women at 24 to 36 weeks of gestation, aged 18 years or more, diagnosed with pregnancy-related LBPGP and who had not previously received ear acupuncture. The trial was conducted from March 2014 to December 2016. Participants were randomly assigned (1:1:1:1) to receive standard obstetric care plus two sessions (over two weeks) of verum ear acupuncture, or non-specific ear acupuncture, or placebo ear acupuncture, or standard obstetric care alone. The primary outcome was change in pain intensity, assessed using a visual analogue scale (0 to 100 mm) from baseline to the end of treatment (T2). Secondary outcomes included change or presence of pain at 3 months (T3) and at one year (T4) postpartum, and changes in responses to the Roland Morris disability questionnaire (RMDQ) and Short Form-12 Health Survey (SF-12) at the end of treatment. RESULTS: 55 women were randomised to each group, and 205 completed the study. With respect to baseline values, the reduction in pain intensity among the verum ear acupuncture group versus Standard obstetric care was significantly greater, both at T2 (65.8%, 95%CI 56.2 to 75.3 versus 25.1%, 95%CI 15.3 to 34.9) and at T3 (93.8%, 95%CI 88.7 to 99.0 versus 67.9%, 95%CI 55.3 to 80.5). Moreover, significant changes were found in the verum ear acupuncture group versus standard obstetric care at T2, in reduced RMDQ scores (70.9%, 95%CI 61.8 to 80.1 versus 21.2%, 95%CI 8.6 to 33.7) and in increased SF-12 scores on the physical scale (40.5%, 95%CI 31.5 to 49.4 versus 8.1%, 95%CI 0.8 to 15.5). CONCLUSIONS: After two weeks' treatment, ear acupuncture, applied by midwives, and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.

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