Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
Condition: Low Back Pain; Pregnancy
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine to what extent and by what physiological mechanisms
      Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy,
      labor and delivery.
    

Detailed description: 
      The osteopathic philosophy of health is built on a model in which basic body functions are
      coordinated and integrated by the musculoskeletal system. Osteopathic medical students are
      taught to consider these aspects in assessing, diagnosing, and treating the individual
      patient. As a treatment method that reflects the osteopathic philosophy, osteopathic
      manipulative medicine (OMM) is a body-based modality in which the patient is evaluated and
      treated as a whole to improve physiologic functioning and remove impediments to optimal
      health and functioning.

      During pregnancy, a woman's body is challenged by significant and extensive physiological and
      biomechanical changes. Some physiological changes, such as increased fluid volume and
      sympathetic tone, may lead to consequences such as edema, preterm labor, and
      meconium-staining of the amniotic fluid. The biomechanical state of the woman's body is also
      drastically affected; as the fetus grows and the uterus expands, the center of gravity shifts
      forward, rotating the pelvis anteriorly and increasing the lordosis of the low back, and may
      also affect the motion of the hips and legs. These postural changes also have consequences
      such as low back pain, decreased functional status, and altered gait. Both these physiologic
      and biomechanical consequences can have a significant long-term impact on the health of the
      mother and child.

      OMM is theorized to facilitate the body's adjustment to the physiological and biomechanical
      demands of pregnancy and improve the outcomes of pregnancy, labor and delivery. Clinical case
      studies report reduced back pain, shorter labor, and fewer incidences of peripartum
      complications in patients who receive prenatal OMM. However, to date we have found no
      published systematic investigations of the efficacy of OMM in managing the adverse effects
      that pregnancy has on a woman's musculoskeletal system, nor have we found any published
      systematic studies to prove the mechanisms of action of OMM in managing pain, edema, or gait
      in pregnant patients.

      Thus, the overall question that guides this proposal is: to what extent and by what
      physiological mechanisms does Osteopathic Manipulative Medicine (OMM) affect selected
      conditions related to pregnancy, labor and delivery? Based on the principles and theories of
      OMM and the limited previous studies, the hypothesis of this study is that OMM improves
      clinical outcomes including low back pain, functional status, incidence of meconium-stained
      amniotic fluid, and complications of labor and delivery, and that the physiological changes
      related to improved autonomic regulation, peripheral hemodynamic regulation, and
      biomechanical changes related to gait are, in part, responsible for these clinical benefits.
    

Intervention name(s): Osteopathic Manipulative Treatment; Placebo Ultrasound
Intervention type(s): Other; Other
Intervention description(s): OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning.; In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT.
The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects.
Other intervention name(s): Sham Ultrasound Therapy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Osteopathic Manipulative Medicine; Osteopathic Manipulative Treatment; Pregnancy; Physiologic; Gait; Low back pain; Heart rate variability