Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by University of North Texas Health Science Center.
Recruitment status was Recruiting

Sponsor:

Collaborators:

National Center for Complementary and Alternative Medicine (NCCAM)

American Osteopathic Association

Information provided by:

University of North Texas Health Science Center

ClinicalTrials.gov Identifier:

NCT00426244

First received: January 22, 2007

Last updated: April 16, 2010

Last verified: March 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
Low Back Pain Pregnancy	Other: Osteopathic Manipulative Treatment Other: Placebo Ultrasound Other: Standard Care	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:

Roland-Morris Low Back Pain and Disability Questionnaire at each visit. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Quadruple Visual Analog Scale at each visit. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Ware's Short Form-12 (SF-12)at each visit. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Heart rate and blood pressure variability as measured by ECG and power spectral analysis. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Step length as measured by the GAITRite walkway. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Foot angle of progression as measured by the GAITRite walkway. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Gait Symmetry as measured by the GAITRite walkway. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CLINICAL STUDY [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Subject Confidence in Treatment Assessment at visits 1,7,and 9. [ Time Frame: 5 yers ] [ Designated as safety issue: No ]
Meconium staining of the amniotic fluid as recorded on the delivery record. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Heart rate as measured by ECG. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Arterial pressure as measured by finger photoplethysmographic monitor. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Respiration as measured by a strain gauge belt. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Saphenous vein diameter and flow as measured by surface ultrasound. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Total leg volume as estimated by strain gauge plethysmography. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Tissue water content as measured by surface dielectric probe. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Venous flow rate as measured by calf plethysmography. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Gait cadence as measured by the GAITRite walkway. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: Placebo Ultrasound	Other: Placebo Ultrasound The treatments were provided by the same physicians who provided OMT. 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.
Active Comparator: OMT	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	Other: Standard Care 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426244

Contacts

Contact: Mayra Rodriguez, BS

817-735-2910

marodrig@hsc.unt.edu

Locations

United States, Texas
University of North Texas Health Science Center - Osteopathic Research Center	Recruiting
Fort Worth, Texas, United States, 76107
Contact: Mayra Rodriguez, BS 817-735-2910 marodrig@hsc.unt.edu
Principal Investigator: Kendi Hensel, D.O.

Sponsors and Collaborators

University of North Texas Health Science Center

National Center for Complementary and Alternative Medicine (NCCAM)

American Osteopathic Association

Investigators

Principal Investigator:

Kendi Hensel, D.O.

University of North Texas Health Science Center - Osteopathic Research Center

More Information

Publications:

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Responsible Party:	Kendi Lee Hensel, DO, University of North Texas
ClinicalTrials.gov Identifier:	NCT00426244 History of Changes
Other Study ID Numbers:	K23 AT003304-01A1, K23AT003304-01A1, K23 AT003304-01A1
Study First Received:	January 22, 2007
Last Updated:	April 16, 2010
Health Authority:	United States: Federal Government

Keywords provided by University of North Texas Health Science Center:

Osteopathic Manipulative Medicine
Osteopathic Manipulative Treatment
Pregnancy
Physiologic

Gait
Low back pain
Heart rate variability

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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