Dr Licciardone expresses concern regarding data from a 2015 article by Hensel et al¹ that directly addressed the question of treatment effectiveness. In that Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study, pregnant women in the OMT group showed improvement over those in the usual care only group in all but 1 measure. A subsequent PROMOTE study showed that the OMT techniques used in the study were safe for use during pregnancy.² However, when the placebo ultrasound therapy group outcomes were compared with the OMT group outcomes, no statistically significant differences were reported, as Dr Licciardone correctly states. We discussed our theories to explain this occurrence in the article.¹ 

Licciardone and Aryal³ previously published data that evaluated effectiveness of OMT in reducing risk of progressive back-pain dysfunction using the 2009 Cochrane Back Review Group recommendations. Their findings showed marginal benefits of OMT vs placebo ultrasound therapy in pregnant women (N=144; P=.046). The authors acknowledged that the sample size used in their study was small, potentially explaining why they reported a marginal difference. Direct comparison with their findings would require different analyses of the PROMOTE data. Dr Licciardone also references an earlier analysis of his data that examined the effectiveness of OMT in pregnant women compared with sham ultrasound therapy and standard care⁴; this analysis was comparable to the 2015 study by Hensel et al¹ in that the placebo ultrasound group did not statistically differ from the OMT group in posttreatment back-specific dysfunction. 

Given the findings of the current study² and previous study,¹ we stand by our conclusion that the OMT protocol used in the PROMOTE study appears to be a safe² and effective way of managing low back pain and its associated disability during pregnancy.^1,3,4 We acknowledge the concern Dr Licciardone expresses regarding the potential risks of teaching these techniques to less experienced practitioners. Although it is not uncommon for study protocols to be published^5,6 for both reproducibility and educational purposes, appropriate training is expected of practitioners, as is the case with any OMT technique. For this reason, training in this protocol has been conducted at colleges of osteopathic medicine and at national osteopathic meetings of the American Academy of Osteopathy, the American College of Osteopathic Obstetricians and Gynecologists, and the American Osteopathic Association. In the almost 10 years that these protocols have been taught in these settings, no adverse events have been reported to date, to our knowledge. 

Although standardized OMT protocols are more frequently used, we also support the development of personalized interventions, which may be based on favorable OMT response profiles, as suggested by Dr Licciardone, or on other factors identified by scientific findings. Additional research is required to fully inform such personalization, and we hope that data from the PROMOTE studies aid in this pursuit.