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A Pilot Clinical Trial of Osteopathic Manipulative Treatment During Third Trimester Pregnancy

Journal: The Journal of the American Osteopathic Association Date: 2007/08, 107(8):Pages: 329. doi: Subito , type of study: randomized controlled trial

Full text    (https://www.degruyter.com/document/doi/10.7556/jaoa.2007.107.8.327/html)

Keywords:

female [399]
OMT [3102]
osteopathic manipulative treatment [3124]
pilot study [134]
pregnancy [145]
randomized controlled trial [766]
women [353]

Abstract:

Purpose: The primary purpose of this study was to explore the potential therapeutic effects of osteopathic manipulative treatment (OMT) during the third trimester of pregnancy. Methods: All study procedures were approved by IRB and the study was registered with ClinicalTrials.gov (NCT00298935). Exclusion criteria included either of the following: (1) intent to deliver at a non-designated hospital or (2) high risk pregnancy as determined by the attending obstetrician. Each subject was randomized to one of three treatment groups: (1) usual obstetrical care and OMT (UOBC+OMT); (2) usual obstetrical care and sham ultrasound treatment (UOBC+SUT); or (3) usual obstetrical care only (UOBC only). The UOBC+OMT and UOBC+SUT groups were scheduled to receive treatments at the 30th week (visit 1), 32nd week (visit 2), 34th week (visit 3), 36th week (visit 4), 37th week (visit 5), 38th week (visit 6), and 39th week (visit 7). The primary outcome measures included: (1) an 11-point scale for the typical or average level of back pain; (2) the Roland-Morris Disability Questionnaire; and (3) the SF-12 Version 2 Health Survey (SF-12) scale score for bodily pain and the summary scores for physical health and mental health. All analyses were based on the intention-to-treat principle. Missing data for all primary outcomes were imputed using the carry-forward method. Repeated measures analysis of covariance (ANCOVA) was used to test the hypotheses. Results: A total of 49, 48, and 49 subjects were randomized to the UOBC+OMT, UOBC+SUT, and UOBC only groups, respectively. Typical or average back pain levels decreased over time in the UOBC+OMT group, remained essentially unchanged in the UOBC+SUT group, and increased in the UOBC only group (ANCOVA treatment group x time interaction, P=.02). The Roland-Morris disability scores increased over time in all three treatment groups; however, the rate of increase was significantly different among the groups (ANCOVA treatment group x time interaction, P<.001). Disability progressed less rapidly in the UOBC+OMT group than in the UOBC only group (P<.001), and there was also a trend toward less rapid progression in the UOBC+OMT group in comparison with the UOBC+SUT group (P=.08). Conclusion: OMT was associated with favorable disability and pain outcomes during the third trimester of pregnancy. Supported by a grant from the Osteopathic Heritage Foundations.


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