Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

Low Back Pain Clinical Trial

Official title:

Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298935
• Other study ID #: 20-102
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2006
• Last updated: June 21, 2013
• Start date: July 2003
• Est. completion date: June 2006

Study information

• Verified date: June 2013
• Source: University of North Texas Health Science Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain
• Musculoskeletal Diseases
• Pregnancy Complications

Intervention

Procedure:
• Osteopathic manipulative treatment (OMT)

Locations

Country	Name	City	State
United States	Osteopathic Research Center	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of North Texas Health Science Center	Osteopathic Heritage Foundations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of premature labor and delivery as well as obstetrical complications during delivery