Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women - Full Text View

Sponsors and Collaborators:	University of North Texas Health Science Center Osteopathic Heritage Foundations
Information provided by:	University of North Texas Health Science Center
ClinicalTrials.gov Identifier:	NCT00298935

Purpose

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	Intervention	Phase
Low Back Pain Musculoskeletal Diseases Pregnancy Complications	Procedure: Osteopathic manipulative treatment (OMT)	Phase II

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy

Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	146
Study Start Date:	July 2003
Study Completion Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298935

Locations

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

Sponsors and Collaborators

University of North Texas Health Science Center

Osteopathic Heritage Foundations

Investigators

Principal Investigator:

John C. Licciardone, D.O., M.S.

Osteopathic Research Center

More Information

Study ID Numbers:	20-102
Study First Received:	March 2, 2006
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00298935
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Texas Health Science Center:

Randomized Controlled Trial
Pregnant Women

Study placed in the following topic categories:

Signs and Symptoms
Pregnancy Complications
Musculoskeletal Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009