NCT00426244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

5.3 years

First QC Date

January 22, 2007

Last Update Submit

August 17, 2018

Conditions

Low Back PainPregnancy

Keywords

Osteopathic Manipulative MedicineOsteopathic Manipulative TreatmentPregnancyPhysiologicGaitLow back painHeart rate variability

Outcome Measures

Primary Outcomes (9)

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

    5 years

  • Quadruple Visual Analog Scale at each visit.

    5 years

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

    5 years

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

    5 years

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

    5 years

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

    5 years

  • Step length as measured by the GAITRite walkway.

    5 years

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

    5 years

  • Gait Symmetry as measured by the GAITRite walkway.

    5 years

Secondary Outcomes (15)

  • CLINICAL STUDY

    5 years

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

    5 yers

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

    5 years

  • 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.

    5 years

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

    5 years

  • +10 more secondary outcomes

Study Arms (3)

Placebo Ultrasound

SHAM COMPARATOR

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: Placebo Ultrasound

Osteopathic Manipulative Treatment

ACTIVE COMPARATOR

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: Osteopathic Manipulative Treatment

Standard Care

NO INTERVENTION

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.

Interventions

Osteopathic Manipulative TreatmentOTHER

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.

Osteopathic Manipulative Treatment
Placebo UltrasoundOTHER

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.

Also known as: Sham Ultrasound Therapy
Placebo Ultrasound

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Deemed high risk by the obstetrician (including but not limited to: abruptio placenta, placenta previa, severe pre-eclampsia/eclampsia, vaginal bleeding, gestational diabetes)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (70)

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  • Hensel KL, Roane BM, Chaphekar AV, Smith-Barbaro P. PROMOTE Study: Safety of Osteopathic Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes. J Am Osteopath Assoc. 2016 Nov 1;116(11):698-703. doi: 10.7556/jaoa.2016.140.

    PMID: 27802555DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kendi Hensel, D.O., Ph.D.

    University of North Texas Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 24, 2007

Study Start

April 1, 2006

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

US(1)