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.