Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

This study has been completed.
Osteopathic Heritage Foundations
Information provided by:
University of North Texas Health Science Center Identifier:
First received: March 2, 2006
Last updated: June 21, 2013
Last verified: June 2013

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00298935

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

No publications provided Identifier: NCT00298935     History of Changes
Other Study ID Numbers: 20-102
Study First Received: March 2, 2006
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Texas Health Science Center:
Randomized Controlled Trial
Pregnant Women

Additional relevant MeSH terms:
Low Back Pain
Musculoskeletal Diseases
Pregnancy Complications
Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on November 27, 2015