Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women
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|ClinicalTrials.gov Identifier: NCT00298935|
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : June 24, 2013
The purpose of this study is to determine whether osteopathic manipulative treatment (OMT):
- decreases pain and improves physical functioning in women during the third trimester of pregnancy
- decreases complications during obstetrical delivery
- improves quality of life in the post-partum period
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Musculoskeletal Diseases Pregnancy Complications||Procedure: Osteopathic manipulative treatment (OMT)||Phase 2|
Women experience multiple changes in their anatomy and physiology during pregnancy that may cause pain and adversely affect quality of life. Additionally, about ten percent of women will experience signs and symptoms of pre-eclampsia or pre-term labor during their first pregnancy.
Preliminary studies of osteopathic manipulative treatment (OMT) have demonstrated a decrease in pain during pregnancy, although the mechanisms responsible for this effect are unclear.
Another theory is that osteopathic manipulative treatment (OMT) may help normalize sympathetic outflow, thereby minimizing pregnancy complications. A recently published retrospective study also suggests that pregnant women receiving osteopathic manipulative treatment (OMT) may be at lower risk for pre-term delivery and the presence of meconium during delivery.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy|
|Study Start Date :||July 2003|
|Actual Study Completion Date :||June 2006|
- Visual analogue scale for pain, Roland-Morris Disability Questionnaire, and SF-12 Health Status Survey during third trimester of pregnancy and continuing six weeks post-partum
- Occurrence of premature labor and delivery as well as obstetrical complications during delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298935
|United States, Texas|
|Osteopathic Research Center|
|Fort Worth, Texas, United States, 76107|
|Principal Investigator:||John C. Licciardone, D.O., M.S.||Osteopathic Research Center|