A Pilot Clinical Trial of OMT and Pregnancy by the national Osteopathic Research Center

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A woman’s first pregnancy brings about adverse changes in her biomechanical structure and overall physiology that commonly leads to problems before, during and after her delivery. There is evidence that Osteopathic Manipulative Treatment (OMT) is used extensively in pregnant patients. We propose to conduct a prospective randomized, blinded, controlled pilot study to examine the effect of OMT on pain and quality of life during and after the third trimester of a first pregnancy.

84 primigravida subjects will be recruited and randomly assigned to one of three treatment arms of this pilot study: 1) OMT; 2) sub-therapeutic placebo ultrasound; and 3) no treatment. During the participants’ third trimester and post-partum period, they will all receive standard obstetrical care from their obstetricians at the University of North Texas Health Science Center-Fort Worth, Obstetrics & Gynecology (OB/GYN) Clinic. Subsequently, they will deliver their babies at the Osteopathic Medical Center of Texas. Our primary outcome measure will be to evaluate the efficacy of OMT in: 1) decreasing low back and pelvic pain in the pre- and post-partum period; and 2) improving the overall quality of life in the pre- and post-partum period. Our secondary outcome measure will be to preliminarily examine the efficacy of OMT to decrease the incidence of complications of pregnancy, labor, and delivery. Pain in the low back and pelvis will be separately evaluated at each pre- and post-natal visit using the Quadruple Visual Analog Pain Scale. Treatment effects on disability and quality of life will be assessed utilizing the Roland-Morris Low Back Pain and Disability Questionnaire and the SF-12v2 Short Form General Health Survey. The relative potencies of placebo effect in each of the three treatment arms will be assessed via a Subject Confidence-in-Treatment Assessment administered at the beginning and end of the study. Pregnancy complications will be recorded and analyzed for treatment effects. Statistical analysis will seek to determine the significance of epidemiological cofactors versus treatment effects among the three treatment groups before drawing definitive conclusions.
If a positive treatment effect is discovered, this project will be followed by a multi-center study of sufficient statistical power to definitively determine the clinical efficacy of OMT in conjunction with standard obstetrical care of third trimester primigravida women.