Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

Phase 2

Completed

• Conditions: Low Back Pain; Musculoskeletal Diseases; Pregnancy Complications

• Registration Number: NCT00298935
• Lead Sponsor: University of North Texas Health Science Center

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-03
• Study Completion: 2006-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Occurrence of premature labor and delivery as well as obstetrical complications during delivery

Trial Locations

Locations (1)

Osteopathic Research Center; 🇺🇸 Fort Worth, Texas, United States