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
1 Pain Treatment Unit. Doña Mercedes Primary Health Care Centre, Segovia s/n, Dos Hermanas 41701, Spain
2 Carlos III Health Institute, Network of Research in Health Services in Chronic Diseases (REDISSEC), Sinesio Delgado 4, Madrid 28029, Spain
3 San Andrés Torcal Primary Health Care Centre, José Palanca s/n, Málaga 29003, Spain
4 El Lugar Primary Health Care Centre, Jesús Nazareno s/n, Chiclana 11130, Spain
5 Mallorca Cancer Registry. Balearic Islands Public Health Department, Hospital Psiquiàtric, Camí de Jesús 40, Palma 07010, Spain
6 Vélez Sur Primary Health Care Centre, Fernando Vivar s/n, Vélez-Málaga 29700, Spain
7 Support Research Unit, Costa del Sol Hospital, Autovia A-7, Km 187, Marbella 29603, Spain
Trials 2014, 15:288 doi:10.1186/1745-6215-15-288Published: 16 July 2014
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.
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.
Current Controlled Trials ISRCTN41033073 (date 20/03/2014).