Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

Summary

The purpose of this study is to determine to what extent and by what physiological mechanisms Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy, labor and delivery.

Conditions

• Low Back Pain
• Pregnancy

Interventions

OTHER

Osteopathic Manipulative Treatment

OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning.

OTHER

Placebo Ultrasound

In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT. The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• American Osteopathic Association

  collaborator OTHER

• American Academy of Osteopathy

  collaborator OTHER

• Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists

  collaborator UNKNOWN

• Osteopathic Heritage Foundations

  collaborator OTHER

• University of North Texas Health Science Center

  lead OTHER

Principal Investigators

• Kendi Hensel, D.O., Ph.D. · University of North Texas Health Science Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-04-30

Primary Completion

2011-07-31

Completion

2011-09-30

Countries

• United States

Study Locations