The Journal of the American Osteopathic Association, 2005/07, 105(7):320-321. doi: 10.7556/jaoa.2005.105.7.317, type of study: ,rct,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

Full text    (https://www.degruyter.com/document/doi/10.7556/jaoa.2005.105.7.317/html)

Keywords:

female [655]
OMT [3925]
osteopathic manipulative treatment [3946]
pilot study [216]
pregnancy [174]
randomized controlled trial [947]
women [608]

Abstract:

Hypothesis: Osteopathic manipulative treatment (OMT) may reduce pain, improve functioning, and lead to better clinical outcomes during the third trimester of pregnancy, labor and delivery, and the post-partum period. Methods: Subjects for this randomized clinical trial have been recruited since August 2003 in the Department of Obstetrics and Gynecology at the University of North Texas Health Science Center. Approximately 100 subjects are expected to complete the trial. Subjects are enrolled at the 28th week of pregnancy. Exclusion criteria include any of the following: (1) presentation for obstetrical care following the 28th week of pregnancy; (2) intent to deliver at a non-designated hospital; and (3) high-risk pregnancy as determined by the attending obstetrician. The latter category includes, but is not limited to, maternal age, vaginal bleeding, gestational diabetes, preeclampsia/eclampsia, placenta previa, and abruptio placenta. Each subject is randomized to one of three groups: (1) usual obstetrical care and OMT (UOBC+OMT); (2) usual obstetrical care and sham ultrasound treatment (UOBC+SUT); and (3) usual obstetrical care only (UOBC only). The OMT and sham ultrasound treatments are provided by licensed physicians during seven prenatal visits (assuming a full-term pregnancy) and two post-partum visits. The primary outcomes include: (1) a visual analogue scale for low back pain; and (2) the Roland-Morris Disability Questionnaire. Secondary outcomes include: (1) the Medical Outcomes Study Short Form-12 scales; and (2) maternal and fetal complications during pregnancy, labor, and delivery. Results: Of the first 900 clinic patients screened through March 2005, 351 (39%) were eligible for inclusion in the trial and 99 (28% of eligibles) elected to participate and were randomized. Of these, 48 (49%) have completed the trial, 20 (20%) are currently enrolled, and 31 (31%) withdrew of their own volition or because of the incidence of a high-risk pregnancy complication. Conclusions: The trial continues to recruit and follow subjects. Comprehensive data analyses will be performed at thetrial’s conclusion. If favorable outcomes are observed, a larger clinical trial will be warranted.