Trial record 7 of 22 for:    ultrasound [TREATMENT] AND prenatal [ALL-FIELDS] | Open Studies

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
American Osteopathic Association
Investigators
Principal Investigator: Kendi Hensel, D.O. University of North Texas Health Science Center - Osteopathic Research Center
  More Information

Publications:
Lynch FW. The pelvic articulations during pregnancy, labor and the puerperium: An X-ray study. Surgery, Gynecology, and Obstetrics 30: 575-580, 1920.
Treadwell RC, Magnus WW. Sacral shear: Review and a new treatment method for obstetricial patients. AAO Journal (Spring): 16-18, 1996.
Heckman JD, Sassard R. Current Concepts Review: Musculoskeletal Considerations in Pregnancy. The Journal of Bone and Joint Surgery 76-A(11): 1720-1730, 1994.
Brandy RE, Rottman J, Kappler RE, Veith EK. Forty first Annual AOA Research Conference Abstracts, 1997: Part 1: Osteopathic Manipulation to Treat Musculoskeletal Pain Associated with Pregnancy. JAOA 97(8): 479, 1997.
Whiting LM. Can the Length of Labor be Shortened by Osteopathic Treatment. Journal of the American Osteopathic Association (11): 917-921, 1911.
Whiting LM. The osteopathic management of pregnancy and the reduction of obstetrical mortality. Journal of the American Osteopathic Association 33(8): 531-533, 1934.
Still, EM. Osteopathic Obstetrics. Journal of Osteopathy 4(4): 203-204, 1897.
Dooley W. Osteopathy's Contribution to Prenatal Care. Journal of the American Osteopathic Association 46(1): 6-7, 1946.
Hart LM. Obstetrical practice. Journal of American Osteopathic Association (July): 609-614, 1918.
King HH, Osteopathic manipulative treatment in prenatal care: Evidence supporting improved outcomes and health policy implications. The American Academy of Osteopathy Journal (Summer): 25-33, 2000.
Taylor GW. The osteopathic management of nausea and vomiting of pregnancy. Journal of American Osteopathic Association 48(11): 581-582, 1949.
Troyanovich S. Pregnancy and the Chiropractic Advantage. Today's Chiropractic, 21(6): 46-48, 1992.
Kuchera ML, Kuchera WA. (1994).Osteopathic Considerations in Systemic Dysfunction, revised 2nd Ed. Greyden Press; Columbus, OH; pp 55, 85, 187, 193.
Smutny CJ, Wells WR, Bosak A. Osteopathic Considerations in Parkinson's Disease. Journal of the American Osteopathic Association 98 (7): 389, 1998.
Wells MR, McCarty CL, Smutny CJ, Scandalis TA, Dittrich F, Fazzini EA Osteopathic Manipulation in the Management of Parkinson's Disease: Preliminary Findings. The Journal of the American Osteopathic Association 100(8): 522, 2000.
Guadagnino MR. Spinal manipulative therapy for 12 pregnant patients suffering from low back pain. Journal of Chiropractic Technique 11(3): 108-112, 1999.
Webster KE, Wittwer E, Feller JA. Validity of the GAITRite® walkway system for the measurement of averaged and individual step parameters of gait. GAIT & Posture. October 2004.
Graham KE, Shaw HH, Mills M, Cotton L. Pregnancy, 3rd Trimester and Pre-Delivery: Goals of OMM in Pregnant Patient during Third Trimester and Pre-Delivery. Anatomic and Physiologic Basis of Osteopathic Manipulative Medicine in Visceral Disease. 1st Edition, 74-75, 2001.
Price DD, Harkins SW. Psychophysical Approaches to Pain Measurement and Assessment. In Turk DC, Melzack R, Editors: Handbook of Pain Assessment, New York: Guliford Press, 1992: 11-132.
Johnson K. An Integrated Approach for Treating the OB Patient: Treating the Five Diaphrams of the Body, Part I. American Academy of Osteopathy Journal (Winter): 6-9, 1991.
Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000.

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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014