Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

August 17, 2018 updated by: Kendi Hensel, DO, PhD, University of North Texas Health Science Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The osteopathic philosophy of health is built on a model in which basic body functions are coordinated and integrated by the musculoskeletal system. Osteopathic medical students are taught to consider these aspects in assessing, diagnosing, and treating the individual patient. As a treatment method that reflects the osteopathic philosophy, osteopathic manipulative medicine (OMM) is a body-based modality in which the patient is evaluated and treated as a whole to improve physiologic functioning and remove impediments to optimal health and functioning.

During pregnancy, a woman's body is challenged by significant and extensive physiological and biomechanical changes. Some physiological changes, such as increased fluid volume and sympathetic tone, may lead to consequences such as edema, preterm labor, and meconium-staining of the amniotic fluid. The biomechanical state of the woman's body is also drastically affected; as the fetus grows and the uterus expands, the center of gravity shifts forward, rotating the pelvis anteriorly and increasing the lordosis of the low back, and may also affect the motion of the hips and legs. These postural changes also have consequences such as low back pain, decreased functional status, and altered gait. Both these physiologic and biomechanical consequences can have a significant long-term impact on the health of the mother and child.

OMM is theorized to facilitate the body's adjustment to the physiological and biomechanical demands of pregnancy and improve the outcomes of pregnancy, labor and delivery. Clinical case studies report reduced back pain, shorter labor, and fewer incidences of peripartum complications in patients who receive prenatal OMM. However, to date we have found no published systematic investigations of the efficacy of OMM in managing the adverse effects that pregnancy has on a woman's musculoskeletal system, nor have we found any published systematic studies to prove the mechanisms of action of OMM in managing pain, edema, or gait in pregnant patients.

Thus, the overall question that guides this proposal is: to what extent and by what physiological mechanisms does Osteopathic Manipulative Medicine (OMM) affect selected conditions related to pregnancy, labor and delivery? Based on the principles and theories of OMM and the limited previous studies, the hypothesis of this study is that OMM improves clinical outcomes including low back pain, functional status, incidence of meconium-stained amniotic fluid, and complications of labor and delivery, and that the physiological changes related to improved autonomic regulation, peripheral hemodynamic regulation, and biomechanical changes related to gait are, in part, responsible for these clinical benefits.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The woman must have medical clearance from her obstetrician at each study visit
  • Must be less than or at 30 weeks gestation at the start of the study

Exclusion Criteria:

  • Deemed high risk by the obstetrician (including but not limited to: abruptio placenta, placenta previa, severe pre-eclampsia/eclampsia, vaginal bleeding, gestational diabetes)
  • Age 17 years or younger. Females 17 years of age and younger are considered pediatric high risk pregnancies and therefore ineligible for inclusion
  • If a patient receives any other manual therapies such as massage, physical therapy, or chiropractic therapy, during the trial, she will be dropped from the study
  • Subjects with a history of syncope either before or during this pregnancy will be excluded from participation in the substudy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: 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.
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.

Other Names:
  • Sham Ultrasound Therapy
ACTIVE_COMPARATOR: 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: 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.
NO_INTERVENTION: Standard Care
Subject only receives care from her OB provider. Subjects were allowed to receive conventional obstetrical care with the exception of OMT, massage therapy, physical therapy, chiropractic manipulation, or therapeutic ultrasound intended to treat musculoskeletal disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Roland-Morris Low Back Pain and Disability Questionnaire at each visit.
Time Frame: 5 years
5 years
Quadruple Visual Analog Scale at each visit.
Time Frame: 5 years
5 years
Ware's Short Form-12 (SF-12)at each visit.
Time Frame: 5 years
5 years
PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame: 5 years
5 years
Heart rate and blood pressure variability as measured by ECG and power spectral analysis.
Time Frame: 5 years
5 years
BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame: 5 years
5 years
Step length as measured by the GAITRite walkway.
Time Frame: 5 years
5 years
Foot angle of progression as measured by the GAITRite walkway.
Time Frame: 5 years
5 years
Gait Symmetry as measured by the GAITRite walkway.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
CLINICAL STUDY
Time Frame: 5 years
5 years
Subject Confidence in Treatment Assessment at visits 1,7,and 9.
Time Frame: 5 yers
5 yers
Meconium staining of the amniotic fluid as recorded on the delivery record.
Time Frame: 5 years
5 years
Other outcomes of pregnancy, labor and delivery including incidence of high-risk status, incidence of pre-term labor, length of labor, use of forceps or suction device, and pain medication use as recorded in the prenatal and delivery record.
Time Frame: 5 years
5 years
PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame: 5 years
5 years
Heart rate as measured by ECG.
Time Frame: 5 years
5 years
Arterial pressure as measured by finger photoplethysmographic monitor.
Time Frame: 5 years
5 years
Respiration as measured by a strain gauge belt.
Time Frame: 5 years
5 years
Saphenous vein diameter and flow as measured by surface ultrasound.
Time Frame: 5 years
5 years
Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius
Time Frame: 5 years
5 years
Total leg volume as estimated by strain gauge plethysmography.
Time Frame: 5 years
5 years
Tissue water content as measured by surface dielectric probe.
Time Frame: 5 years
5 years
Venous flow rate as measured by calf plethysmography.
Time Frame: 5 years
5 years
BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame: 5 years
5 years
Gait cadence as measured by the GAITRite walkway.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Texas Health Science Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
American Academy of Osteopathy
Osteopathic Heritage Foundations
American Osteopathic Association
Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists

Investigators

  • Principal Investigator: Kendi Hensel, D.O., Ph.D., University of North Texas Health Science Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

January 22, 2007

First Submitted That Met QC Criteria

January 22, 2007

First Posted (ESTIMATE)

January 24, 2007

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23AT003304-01A1 (NIH)
  • 5K23AT003304-05 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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