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Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

Primary Purpose

Low Back Pain, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Placebo Ultrasound
Sponsored by
University of North Texas Health Science Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, Pregnancy, Physiologic, Gait, Low back pain, Heart rate variability

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

No Intervention

Arm Label

Placebo Ultrasound

Osteopathic Manipulative Treatment

Standard Care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CLINICAL STUDY
Subject Confidence in Treatment Assessment at visits 1,7,and 9.
Meconium staining of the amniotic fluid as recorded on the delivery record.
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.
PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Heart rate as measured by ECG.
Arterial pressure as measured by finger photoplethysmographic monitor.
Respiration as measured by a strain gauge belt.
Saphenous vein diameter and flow as measured by surface ultrasound.
Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius
Total leg volume as estimated by strain gauge plethysmography.
Tissue water content as measured by surface dielectric probe.
Venous flow rate as measured by calf plethysmography.
BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Gait cadence as measured by the GAITRite walkway.

Full Information

First Posted
January 22, 2007
Last Updated
August 17, 2018
Sponsor
University of North Texas Health Science Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH), American Osteopathic Association, American Academy of Osteopathy, Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists, Osteopathic Heritage Foundations
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1. Study Identification

Unique Protocol Identification Number
NCT00426244
Brief Title
Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
Official Title
Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH), American Osteopathic Association, American Academy of Osteopathy, Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists, Osteopathic Heritage Foundations

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Pregnancy
Keywords
Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, Pregnancy, Physiologic, Gait, Low back pain, Heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Ultrasound
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Osteopathic Manipulative Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Ultrasound
Other Intervention Name(s)
Sham Ultrasound Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Roland-Morris Low Back Pain and Disability Questionnaire at each visit.
Time Frame
5 years
Title
Quadruple Visual Analog Scale at each visit.
Time Frame
5 years
Title
Ware's Short Form-12 (SF-12)at each visit.
Time Frame
5 years
Title
PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame
5 years
Title
Heart rate and blood pressure variability as measured by ECG and power spectral analysis.
Time Frame
5 years
Title
BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame
5 years
Title
Step length as measured by the GAITRite walkway.
Time Frame
5 years
Title
Foot angle of progression as measured by the GAITRite walkway.
Time Frame
5 years
Title
Gait Symmetry as measured by the GAITRite walkway.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
CLINICAL STUDY
Time Frame
5 years
Title
Subject Confidence in Treatment Assessment at visits 1,7,and 9.
Time Frame
5 yers
Title
Meconium staining of the amniotic fluid as recorded on the delivery record.
Time Frame
5 years
Title
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
Title
PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame
5 years
Title
Heart rate as measured by ECG.
Time Frame
5 years
Title
Arterial pressure as measured by finger photoplethysmographic monitor.
Time Frame
5 years
Title
Respiration as measured by a strain gauge belt.
Time Frame
5 years
Title
Saphenous vein diameter and flow as measured by surface ultrasound.
Time Frame
5 years
Title
Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius
Time Frame
5 years
Title
Total leg volume as estimated by strain gauge plethysmography.
Time Frame
5 years
Title
Tissue water content as measured by surface dielectric probe.
Time Frame
5 years
Title
Venous flow rate as measured by calf plethysmography.
Time Frame
5 years
Title
BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Time Frame
5 years
Title
Gait cadence as measured by the GAITRite walkway.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendi Hensel, D.O., Ph.D.
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States

12. IPD Sharing Statement

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Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

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