OBJECTIVE: To assess the cost-effectiveness of acupuncture for pelvic girdle and low back pain (PGLBP) during pregnancy. DESIGN: Pragmatic-open-label randomised controlled trial. SETTING: Five maternity hospitals. POPULATION: Pregnant women with PGLBP. METHOD: 1:1 randomization to standard care or standard care plus acupuncture (5 sessions by an acupuncturist midwife). MAIN OUTCOME MEASURE: Efficacy: proportion of days with self-assessed pain by numerical rating scale (NRS) <= 4/10. Cost effectiveness (societal viewpoint, time horizon: pregnancy): incremental cost per days with NRS <= 4/10. Indirect non-healthcare costs included daily compensations for sick leave and productivity loss caused by absenteeism or presenteeism. RESULTS: 96 women were allocated to acupuncture and 103 to standard care (total 199). The proportion of days with NRS <= 4/10 was greater in the acupuncture group than in the standard care group (61% versus 48%, p = 0.007). The mean Oswestry disability score was lower in the acupuncture group than with standard care alone (33 versus 38, delta 5, 95% CI 0.8 to 9, p = 0.02). Average total costs were higher in the control group (2,947 Euro) than in the acupuncture group (2,635 Euro, delta -312 Euro, 95% CI -966 to +325 Euro), resulting from the higher indirect costs of absenteeism and presenteeism. Acupuncture was a dominant strategy when both healthcare and non-healthcare costs were included. Costs for the health system (employer and out-of-pocket costs excluded) were slightly higher for acupuncture (1,512 Euro versus 1,452 Euro, delta 60 Euro, 95% CI -272 to +470 Euro). CONCLUSION: Acupuncture was a dominant strategy when accounting for employer costs. A 100% probability of cost-effectiveness was obtained for a willingness to pay of 100 per days with pain NRS <= 4.

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