Research Obstetrics| Volume 212, ISSUE 1, P108.e1-108.e9, January 2015

Download started.


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


      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.


      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.


      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.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to American Journal of Obstetrics & Gynecology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Wang S.M.
        • Dezinno P.
        • Maranets I.
        • Berman M.R.
        • Caldwell-Andrews A.A.
        • Kain Z.N.
        Low back pain during pregnancy: prevalence, risk factors, and outcomes.
        Obstet Gynecol. 2004; 104: 65-70
        • Mogren I.M.
        • Pohjanen A.I.
        Low back pain and pelvic pain during pregnancy: prevalence and risk factors.
        Spine. 2005; 30: 983-991
      1. Educational Council on Osteopathic Principles of the American Association of College of Osteopathic Medicine. Glossary of osteopathic terminology.
        AACOM. 2011; : 1-60
        • Daly J.M.
        • Frame P.S.
        • Rapoza P.A.
        Sacroiliac subluxation: a common, treatable cause of low-back pain in pregnancy.
        Fam Pract Res J. 1991; 11: 149-159
        • Lynch F.
        The pelvic articulations during pregnancy, labor, and the puerperium: an X-ray study.
        in: George Gray Ward J.M.D. Transactions of the American Gynecological Society. American Gynecological Society, Philadelphia1919: 136
        • Ostgaard H.C.
        • Andersson G.B.
        • Schultz A.B.
        • Miller J.A.
        Influence of some biomechanical factors on low-back pain in pregnancy.
        Spine. 1993; 18: 61-65
        • Treadwell R.C.
        • Magnus W.W.
        Sacral shear: review and a new treatment method for obstetrical patients.
        AAOJ. 1996 (Spring); : 16-18
        • Perkins J.
        • Hammer R.L.
        • Loubert P.V.
        Identification and management of pregnancy-related low back pain.
        J Nurse. 1998; 43: 331-340
        • Clinical Guideline subcommittee on low back pain; American Osteopathic Association
        American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain.
        J Am Osteopath Assoc. 2010; 110: 653-666
        • Licciardone J.C.
        • Stoll S.T.
        • Fulda K.G.
        • et al.
        Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial.
        Spine. 2003; 28: 1355-1362
        • Cherkin D.C.
        • Sherman K.J.
        • Deyo R.A.
        • Shekelle P.G.
        A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain.
        Ann Intern Med. 2003; 138: 898-906
        • Licciardone J.C.
        • Minotti D.E.
        • Gatchel R.J.
        • Kearns C.M.
        • Singh K.P.
        Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial.
        Ann Fam Med. 2013; 11: 122-129
        • King H.H.
        • Tettambel M.A.
        • Lockwood M.D.
        • Johnson K.H.
        • Arsenault D.A.
        • Quist R.
        Osteopathic manipulative treatment in prenatal care: a retrospective case control design study.
        J Am Osteopath Assoc. 2003; 103: 577-582
        • Von Korff M.
        • Deyo R.
        • Cherkin D.
        • Barlow W.
        Back pain in primary care: outcomes at 1 year.
        Spine. 1993; 18: 855-862
        • Roland M.
        • Morris R.
        A study of the natural history of back pain: part I, development of a reliable and sensitive measure of disability in low-back pain.
        Spine. 1983; 8: 141-144
        • Stratford P.W.
        • Binkley J.
        • Solomon P.
        • Gill C.
        • Finch E.
        Assessing change over time in patients with low back pain.
        Phys Ther. 1994; 74: 528-533
        • Beurskens A.J.
        • de Vet H.C.
        • Koke A.J.
        Responsiveness of functional status in low back pain: a comparison of different instruments.
        Pain. 1996; 65: 71-76
        • Kimberly P.E.
        • Funk S.L.
        Outline of osteopathic manipulative procedures: the Kimberly manual, millennium edition.
        Walsworth, Marceline (Mo)2000: 316
        • Nicholas A.S.
        • Nicholas E.A.
        Atlas of osteopathic techniques.
        Wolters Kluwer Health/Lippincott Williams & Wilkins, Philadelphia2012
        • O’Connell J.
        Bioelectric fascial activation and release: the physician’s guide to hunting with Dr Still.
        American Academy of Osteopathy, Indianapolis, IN2000
        • DiGiovanna E.L.
        • Schiowitz S.
        • Dowling D.J.
        An osteopathic approach to diagnosis and treatment.
        Lippincott Williams and Wilkins, Philadelphia2005
        • Radjieski J.M.
        • Lumley M.A.
        • Cantieri M.S.
        Effect of osteopathic manipulative treatment on length of stay for pancreatitis: a randomized pilot study.
        J Am Osteopath Assoc. 1998; 98: 264-272
        • Kaptchuk T.
        • Kelley J.
        • Conboy L.
        • et al.
        Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome.
        BMJ. 2008; 336: 999-1003
        • Licciardone J.
        • Buchanan S.
        • Hensel K.
        • King H.
        • Fulda K.
        • Stoll S.
        Osteopathic manipulative treatment of back pain and related symptoms during pregnancy: a randomized controlled trial.
        Am J Obstet Gynecol. 2010; 202: 43.e1-43.e8
        • Fulda K.G.
        • Slicho T.
        • Stoll S.T.
        Patient expectations for placebo treatments commonly used in osteopathic manipulative treatment (OMT) clinical trials: a pilot study.
        Osteopath Med Prim Care. 2007; 1: 3
        • Field T.
        • Figueiredo B.
        • Hernandez-Reif M.
        • Diego M.
        • Deeds O.
        • Ascencio A.
        Massage therapy reduces pain in pregnant women, alleviates prenatal depression in both parents and improves their relationships.
        J Bodyw Mov Ther. 2008; 12: 146-150
        • Etminan M.
        • Sadatsafavi M.
        • Jafari S.
        • Doyle-Waters M.
        • Aminzadeh K.
        • Fitzgerald J.M.
        Acetaminophen use and the risk of asthma in children and adults: a systematic review and metaanalysis.
        Chest. 2009; 136: 1316-1323
        • Eyers S.
        • Weatherall M.
        • Jefferies S.
        • Beasley R.
        Paracetamol in pregnancy and the risk of wheezing in offspring: a systematic review and meta-analysis.
        Clin Exp Allergy. 2011; 41: 482-489
        • Brandlistuen R.E.
        • Ystrom E.
        • Nulman I.
        • Koren G.
        • Nordeng H.
        Prenatal paracetamol exposure and child neurodevelopment: a sibling-controlled cohort study.
        Int J Epidemiol. 2013; : 1-12
      2. Acetaminophen: Drug Safety Communication–Association with Risk of Serious Skin Reactions. United States Food and Drug Administration website. Available at: Accessed Jan. 13, 2014.

        • Young A.
        • Chaudhry H.J.
        • Rhyne J.
        • Dugan M.
        A census of actively licensed physicians in the United States.
        J Med Reg. 2012; 99: 11-24