Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

June 21, 2013 updated by: University of North Texas Health Science Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Osteopathic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Occurrence of premature labor and delivery as well as obstetrical complications during delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Texas Health Science Center

Collaborators

Osteopathic Heritage Foundations

Investigators

  • Principal Investigator: John C. Licciardone, D.O., M.S., Osteopathic Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 2, 2006

First Posted (ESTIMATE)

March 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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