Abstract
BackgroundAbout 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 designThis 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.DiscussionThis 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 registrationCurrent Controlled Trials ISRCTN41033073 (date 20/03/2014).
Highlights
About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP)
Musculoskeletal pain in pregnant women is often regarded as something that is transient, physiological, and selflimiting, but low back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are associated with an increased risk of suffering these pains in future pregnancies and of the pain becoming chronic [1]
A recent survey showed that over 60% of pregnant women with LBPGP would accept some form of complementary therapy, including acupuncture [27]
Summary
About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). Musculoskeletal pain in pregnant women is often regarded as something that is transient, physiological, and selflimiting, but low back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are associated with an increased risk of suffering these pains in future pregnancies and of the pain becoming chronic [1]. Low back pain is usually defined as occurring between the twelfth rib and the gluteal fold. Pelvic girdle pain is experienced between the posterior iliac crest and the gluteal fold, in the vicinity of the sacroiliac joints. Studies have so far failed to distinguish reliably between the two, and LBP is very likely to be a subgroup of the pelvic pain associated with pregnancy [4]. Similar pathophysiological mechanisms – joint laxity, increased lumbar lordosis, and muscle weakness – have been suggested to be at the cause of both conditions [5,6,7]
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