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Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298935
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : June 24, 2013
Osteopathic Heritage Foundations
Information provided by:
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

Condition or disease Intervention/treatment Phase
Low Back Pain Musculoskeletal Diseases Pregnancy Complications Procedure: Osteopathic manipulative treatment (OMT) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy
Study Start Date : July 2003
Actual Study Completion Date : June 2006

Primary Outcome Measures :
  1. 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 :
  1. Occurrence of premature labor and delivery as well as obstetrical complications during delivery

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298935

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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
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Principal Investigator: John C. Licciardone, D.O., M.S. Osteopathic Research Center
Layout table for additonal information Identifier: NCT00298935    
Other Study ID Numbers: 20-102
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013
Keywords provided by University of North Texas Health Science Center:
Randomized Controlled Trial
Pregnant Women
Additional relevant MeSH terms:
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Pregnancy Complications
Back Pain
Low Back Pain
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms