Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study

Abstract

Objective To evaluate the efficacy of Osteopathic Manipulative Treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and improve selected outcomes of labor and delivery. Study Design PROMOTE was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were randomized to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included seven treatments over nine weeks. The OMT protocol included specific techniques administered by board-certified OMT specialists. Outcomes were assessed using self-report measures for pain and back-related functioning, and medical records for delivery outcomes. Results There were 136 women in the OMT group, 131 in PUT, and 133 in UCO. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back related functioning (P<.001 for both), with outcomes for the OMT group similar to that of the PUT, but both groups were significantly improved compared to UCO. For secondary outcome of meconium- stained amniotic fluid there were no differences between the groups. Conclusion OMT was effective for mitigating pain and functional deterioration compared to the UCO group; however OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during their third trimester.

Evidence-Based Evaluation of Complementary Health Approaches for Pain Management in the United States

“…In pregnant women with LBP, 2 studies compared the benefit of adding OMT or a placebo-ultrasound to usual obstetric care, and reported significant, modest improvements with added care but no significant between-group differences. 28, 29 No RCTs reported significant adverse events.…”

Correction

“…Dr Licciardone expresses concern regarding data from a 2015 article by Hensel et al 1 Given the findings of the current study 2 and previous study, 1 we stand by our conclusion that the OMT protocol used in the PROMOTE study appears to be a safe 2 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…”

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol

“…Published in 2015, the PROMOTE study 20 A standardized OMT protocol is difficult to apply for every patient. In this study, the goal was to create a protocol that would address the dysfunctions seen in most pregnant patients.…”

“…With slight modification, the OMT protocol used in that pilot study was the prototype for the PROMOTE study. 20 The primary hypothesis of the PROMOTE study was that application of an OMT protocol would improve low back pain and functional status in the third trimester of pregnancy and would reduce the incidence of certain complications of pregnancy, labor, and delivery. This hypothesis was measured by selected outcomes of pregnancy: low back pain, functional status, and complications of labor and delivery.…”