Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
Low Back Pain, Pregnancy
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, Pregnancy, Physiologic, Gait, Low back pain, Heart rate variability
Eligibility Criteria
Inclusion Criteria:
- The woman must have medical clearance from her obstetrician at each study visit
- Must be less than or at 30 weeks gestation at the start of the study
Exclusion Criteria:
- Deemed high risk by the obstetrician (including but not limited to: abruptio placenta, placenta previa, severe pre-eclampsia/eclampsia, vaginal bleeding, gestational diabetes)
- Age 17 years or younger. Females 17 years of age and younger are considered pediatric high risk pregnancies and therefore ineligible for inclusion
- If a patient receives any other manual therapies such as massage, physical therapy, or chiropractic therapy, during the trial, she will be dropped from the study
- Subjects with a history of syncope either before or during this pregnancy will be excluded from participation in the substudy
Sites / Locations
- University of North Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Sham Comparator
Active Comparator
No Intervention
Placebo Ultrasound
Osteopathic Manipulative Treatment
Standard Care
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.
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.
Subject only receives care from her OB provider. Subjects were allowed to receive conventional obstetrical care with the exception of OMT, massage therapy, physical therapy, chiropractic manipulation, or therapeutic ultrasound intended to treat musculoskeletal disorders.