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:
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

January 22, 2007
April 16, 2010
April 2006
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • 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.
  • CLINICAL STUDY
Complete list of historical versions of study NCT00426244 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Low Back Pain
  • Pregnancy
  • 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

    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.

  • 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.
  • Sham Comparator: Placebo Ultrasound
    Intervention: Other: Placebo Ultrasound
  • Active Comparator: OMT
    Intervention: Other: Osteopathic Manipulative Treatment
  • No Intervention: Standard Care
    Subject only receives care from her OB provider
    Intervention: Other: Standard Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact: Mayra Rodriguez, BS 817-735-2910 marodrig@hsc.unt.edu
United States
 
NCT00426244
K23 AT003304-01A1, K23AT003304-01A1, K23 AT003304-01A1
Yes
Kendi Lee Hensel, DO, University of North Texas
University of North Texas Health Science Center
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • American Osteopathic Association
Principal Investigator: Kendi Hensel, D.O. University of North Texas Health Science Center - Osteopathic Research Center
University of North Texas Health Science Center
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP