Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women
Primary Purpose
Low Back Pain, Musculoskeletal Diseases, Pregnancy Complications
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Osteopathic manipulative treatment (OMT)
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Randomized Controlled Trial, Pregnant Women
Eligibility Criteria
Inclusion Criteria: Third trimester pregnancy Exclusion Criteria: High risk pregnancy Previous use of chiropractic manipulation, osteopathic manipulative treatment (OMT), physical therapy, or therapeutic ultrasound during the current pregnancy
Sites / Locations
- Osteopathic Research Center
Outcomes
Primary Outcome Measures
Visual analogue scale for pain, Roland-Morris Disability Questionnaire, and SF-12 Health Status Survey during third trimester of pregnancy and continuing six weeks post-partum
Secondary Outcome Measures
Occurrence of premature labor and delivery as well as obstetrical complications during delivery
Full Information
NCT ID
NCT00298935
First Posted
March 2, 2006
Last Updated
June 21, 2013
Sponsor
University of North Texas Health Science Center
Collaborators
Osteopathic Heritage Foundations
1. Study Identification
Unique Protocol Identification Number
NCT00298935
Brief Title
Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women
Official Title
Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
Osteopathic Heritage Foundations
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether osteopathic manipulative treatment (OMT):
decreases pain and improves physical functioning in women during the third trimester of pregnancy
decreases complications during obstetrical delivery
improves quality of life in the post-partum period
Detailed Description
Women experience multiple changes in their anatomy and physiology during pregnancy that may cause pain and adversely affect quality of life. Additionally, about ten percent of women will experience signs and symptoms of pre-eclampsia or pre-term labor during their first pregnancy.
Preliminary studies of osteopathic manipulative treatment (OMT) have demonstrated a decrease in pain during pregnancy, although the mechanisms responsible for this effect are unclear.
Another theory is that osteopathic manipulative treatment (OMT) may help normalize sympathetic outflow, thereby minimizing pregnancy complications. A recently published retrospective study also suggests that pregnant women receiving osteopathic manipulative treatment (OMT) may be at lower risk for pre-term delivery and the presence of meconium during delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Musculoskeletal Diseases, Pregnancy Complications
Keywords
Randomized Controlled Trial, Pregnant Women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
146 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulative treatment (OMT)
Primary Outcome Measure Information:
Title
Visual analogue scale for pain, Roland-Morris Disability Questionnaire, and SF-12 Health Status Survey during third trimester of pregnancy and continuing six weeks post-partum
Secondary Outcome Measure Information:
Title
Occurrence of premature labor and delivery as well as obstetrical complications during delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Third trimester pregnancy
Exclusion Criteria:
High risk pregnancy
Previous use of chiropractic manipulation, osteopathic manipulative treatment (OMT), physical therapy, or therapeutic ultrasound during the current pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Licciardone, D.O., M.S.
Organizational Affiliation
Osteopathic Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osteopathic Research Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women
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