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Completed

NCT Number: NCT00426244

Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic manipulative treatment

Other

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.

Placebo Ultrasound

Other

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

Primary outcomes

  1. Roland-Morris Low Back Pain and Disability Questionnaire at each visit.

    Time frame: 5 years

  2. Quadruple Visual Analog Scale at each visit.

    Time frame: 5 years

  3. Ware's Short Form-12 (SF-12)at each visit.

    Time frame: 5 years

  4. PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks)

    Time frame: 5 years

  5. Heart rate and blood pressure variability as measured by ECG and power spectral analysis.

    Time frame: 5 years

  6. BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)

    Time frame: 5 years

  7. Step length as measured by the GAITRite walkway.

    Time frame: 5 years

  8. Foot angle of progression as measured by the GAITRite walkway.

    Time frame: 5 years

  9. Gait Symmetry as measured by the GAITRite walkway.

    Time frame: 5 years

Secondary outcomes

  1. CLINICAL STUDY

    Time frame: 5 years

  2. Subject Confidence in Treatment Assessment at visits 1,7,and 9.

    Time frame: 5 yers

  3. Meconium staining of the amniotic fluid as recorded on the delivery record.

    Time frame: 5 years

  4. 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. PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks)

    Time frame: 5 years

  6. Heart rate as measured by ECG.

    Time frame: 5 years

  7. Arterial pressure as measured by finger photoplethysmographic monitor.

    Time frame: 5 years

  8. Respiration as measured by a strain gauge belt.

    Time frame: 5 years

  9. Saphenous vein diameter and flow as measured by surface ultrasound.

    Time frame: 5 years

  10. Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius

    Time frame: 5 years

  11. Total leg volume as estimated by strain gauge plethysmography.

    Time frame: 5 years

  12. Tissue water content as measured by surface dielectric probe.

    Time frame: 5 years

  13. Venous flow rate as measured by calf plethysmography.

    Time frame: 5 years

  14. BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)

    Time frame: 5 years

  15. Gait cadence as measured by the GAITRite walkway.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Collaborators

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

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 24, 2007
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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