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Letters to the Editor  |   May 2017
Osteopathic Manipulative Treatment During the Third Trimester of Pregnancy
Author Notes
  • Professor and Osteopathic Heritage Foundation Richards-Cohen Distinguished Chair in Clinical Research, University of North Texas Health Science Center-Texas College of Osteopathic Medicine, Fort Worth 
Article Information
Obstetrics and Gynecology / Osteopathic Manipulative Treatment
Letters to the Editor   |   May 2017
Osteopathic Manipulative Treatment During the Third Trimester of Pregnancy
The Journal of the American Osteopathic Association, May 2017, Vol. 117, 289-290. doi:10.7556/jaoa.2017.050
The Journal of the American Osteopathic Association, May 2017, Vol. 117, 289-290. doi:10.7556/jaoa.2017.050
To the Editor: 
Dr Hensel and colleagues recently published the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study protocol1 and findings.2 The protocol included 12 osteopathic manipulative treatment (OMT) techniques used to complement usual obstetric care (UOC) during the third trimester. The primary outcomes were numerical ratings of low back pain and the Roland-Morris Disability Questionnaire (RMDQ). This trial was large, with 400 women randomly assigned to OMT+UOC, placebo ultrasound therapy+UOC, or UOC only.2 Nevertheless, it failed to demonstrate a significant benefit in any primary outcome in women receiving OMT as compared with those receiving placebo ultrasound therapy.2(Table 4) In fact, women who received OMT reported worse outcomes on both the composite measure of pain and RMDQ. Although significant benefits were reported for composite pain and RMDQ when comparing OMT+UOC vs UOC,2(Table 4) neither outcome reflected a treatment effect that was clinically relevant according to evidence standards.3 
My colleagues and I initially reported that OMT was efficacious in achieving statistically significant and clinically important benefits in pain reduction and back-specific functioning during the third trimester.4 A responder analysis of these trial data, not cited by Dr Hensel and colleagues, provides insight on OMT efficacy in preventing back-specific dysfunction.5 Using Cochrane Back Review Group criteria, OMT+UOC was associated with a medium treatment effect vs sham ultrasound therapy+UOC, and a large treatment effect vs UOC only. Responder analysis is now recommended in addition to reporting mean scores for back pain and related outcomes to avoid the skewing of trial results by patients who are clearly insensitive to treatment.6 Such responder analysis has been used to develop an OMT targeting strategy for patients with chronic low back pain.7,8 
The PROMOTE study findings bring into question the conclusion reached by the authors that its protocol appears to be an “effective way to manage low back pain and its associated disability during pregnancy.”1 Although clinical trials involving well-trained practitioners have not clearly identified any safety risk in women treated with OMT during the third trimester,1,4,9 such risks may emerge if OMT were to become widely used in obstetrical practice or administered by less experienced practitioners under the presumption that the techniques are “relatively simple and easily taught.”1 Thus, it is premature to recommend that the PROMOTE study protocol be implemented in obstetrics as indicated by Dr Hensel and colleagues.1 A safer and more practical approach would be to target treatment by experienced practitioners at pregnant women who have favorable OMT response profiles based on emerging research and evidence standards. 
References
Hensel KL, Carnes MS, Stoll ST. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study protocol. J Am Osteopath Assoc. 2016;116(11):716-724. doi: 10.7556/jaoa.2016.142 [CrossRef] [PubMed]
Hensel KL, Buchanan S, Brown SK, Rodriguez M, Cruser dA. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study. Am J Obstet Gynecol. 2015;212(1):108.e101-108.e109. doi: 10.1016/j.ajog.2014.07.043 [CrossRef]
Furlan AD, Pennick V, Bombardier C, van Tulder M. 2009 Updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976). 2009;34(18):1929-1941. doi: 10.1097/BRS.0b013e3181b1c99f [CrossRef] [PubMed]
Licciardone JC, Buchanan S, Hensel KL, King HH, Fulda KG, Stoll ST. Osteopathic manipulative treatment of back pain and related symptoms during pregnancy: a randomized controlled trial. Am J Obstet Gynecol. 2010;202(1):43.e41-43.e48. doi: 10.1016/j.ajog.2009.07.057 [CrossRef]
Licciardone JC, Aryal S. Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria. J Am Osteopath Assoc. 2013;113(10):728-736. doi: 10.7556/jaoa.2013.043 [CrossRef] [PubMed]
Deyo RA, Dworkin SF, Amtmann D, et al Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014;15(6):569-585. [CrossRef] [PubMed]
Licciardone JC, Gatchel RJ, Aryal S. Recovery from chronic low back pain after osteopathic manipulative treatment: a randomized controlled trial. J Am Osteopath Assoc. 2016;116(3):144-155. doi: 10.7556/jaoa.2016.031 [CrossRef] [PubMed]
Licciardone JC, Gatchel RJ, Aryal S. Targeting patient subgroups with chronic low back pain for osteopathic manipulative treatment: responder analyses from a randomized controlled trial. J Am Osteopath Assoc. 2016;116(3):156-168. doi: 10.7556/jaoa.2016.032 [CrossRef] [PubMed]
Hensel KL, Roane BM, Chaphekar AV, Smith-Barbaro P. PROMOTE study: safety of osteopathic manipulative treatment during the third trimester by labor and delivery outcomes. J Am Osteopath Assoc. 2016;116(11):698-703. doi: 10.7556/jaoa.2016.140 [CrossRef] [PubMed]