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Randomized Controlled Trial
. 2015 Jan;212(1):108.e1-9.
doi: 10.1016/j.ajog.2014.07.043. Epub 2014 Jul 25.

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

Kendi L Hensel  1 , Steve Buchanan  2 , Sarah K Brown  3 , Mayra Rodriguez  4 , des Anges Cruser  5
Affiliations
Randomized Controlled Trial

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

Kendi L Hensel et al. Am J Obstet Gynecol. 2015 Jan.

Abstract

Objective: The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery.

Study design: Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were assigned randomly to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included 7 treatments over 9 weeks. The OMT protocol included specific techniques that were administered by board-certified OMT specialists. Outcomes were assessed with the use of 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 women in the PUT group and 133 women in the UCO group. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back-related functioning (P < .001 for both groups), with outcomes for the OMT group similar to that of the PUT group; however, both groups were significantly improved compared with the UCO group. For secondary outcome of meconium-stained amniotic fluid, there were no differences among the groups.

Conclusion: OMT was effective for mitigating pain and functional deterioration compared with UCO; 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 the third trimester.

Keywords: low back pain; osteopathic manipulation; pregnancy.

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Figures

Fig. 1
Fig. 1
Flow of women through the PROMOTE trial.
Fig. 2
Fig. 2. Mean change in self-reported pain and back functioning for each group by study visit
2A. For RDMQ, there was an effect for treatment group, time, and interaction (all P<.001). 2B. For CPI, there was an effect for treatment group, time, and interaction (P<.001, P=.048 and P<.001 respectively). 2C. For Pain Now, treatment group was significant (P<.001), but not time (P=.139). However there was an interaction for group and time (P<.002). 2D. For Pain Average, both treatment group and time were significant (P=.004 and P=.012 respectively), however the interaction was not (P=.185). 2E. For Pain Best, treatment group was significant (P<.001), but not time (P=.845). However there was an interaction for group and time (P=.001). 2F. For Pain Worst, there were differences for treatment group, time, and interaction (P<.001, P=.004 and P<.001 respectively).
See this image and copyright information in PMC

Comment in

  • Osteopathic Manipulative Treatment During the Third Trimester of Pregnancy.
    Licciardone JC. Licciardone JC. J Am Osteopath Assoc. 2017 May 1;117(5):289-290. doi: 10.7556/jaoa.2017.050. J Am Osteopath Assoc. 2017. PMID: 28459477 No abstract available.
  • Response.
    Hensel KL, Roane BM, Smith-Barbaro P. Hensel KL, et al. J Am Osteopath Assoc. 2017 May 1;117(5):290. doi: 10.7556/jaoa.2017.051. J Am Osteopath Assoc. 2017. PMID: 28459479 No abstract available.

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