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Completed

NCT Number: NCT00298935

Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

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

Completed

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Key information

Conditions

Low Back Pain Back Pain Female Urogenital Diseases and Pregnancy Complications Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Osteopathic Research Center

Fort Worth, Texas, 76107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic manipulative treatment (OMT)

Procedure

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Collaborators

  • Osteopathic Heritage Foundations

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Mar 3, 2006
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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