Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- University of North Texas Health Science Center
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Third trimester pregnancy
Exclusion Criteria
- •High risk pregnancy
- •Previous use of chiropractic manipulation, osteopathic manipulative treatment (OMT), physical therapy, or therapeutic ultrasound during the current pregnancy
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Occurrence of premature labor and delivery as well as obstetrical complications during delivery