Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

NCT ID: NCT00298935

Last Updated: 2013-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Low Back Pain Musculoskeletal Diseases Pregnancy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Osteopathic manipulative treatment (OMT)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Osteopathic Heritage Foundations

OTHER

Sponsor Role collaborator

University of North Texas Health Science Center

OTHER

Sponsor Role lead

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Osteopathic Research Center

Locations

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Osteopathic Research Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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20-102

Identifier Type: -

Identifier Source: org_study_id

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