Study of the Effectiveness of Osteopathic Manipulative Tr... | NCT00298935

Studies
Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

NCT00298935

Sponsor

University of North Texas Health Science Center

Status

Completed

Last Update Posted

Jun 24, 2013Estimated

Enrollment

146

Phase

Phase 2

Conditions

Low Back Pain
Musculoskeletal Diseases
Pregnancy Complications

Interventions

Osteopathic manipulative treatment (OMT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Mar 2, 2006

First Submission Date that Met QC Criteria

Mar 2, 2006

First Posted Date

Mar 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2013

Last Update Posted Date

Jun 24, 2013Estimated

Name	Class
Osteopathic Heritage Foundations	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146

Name	Type	Description	Arm Group Labels	Other Names
Osteopathic manipulative treatment (OMT)	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Occurrence of premature labor and delivery as well as obstetrical complications during delivery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John C. Licciardone, D.O., M.S.	Osteopathic Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osteopathic Research Center		Fort Worth	Texas	76107	United States

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain
D009140	Musculoskeletal Diseases
D011248	Pregnancy Complications

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026301	Manipulation, Osteopathic

Ancestor Terms

ID	Term
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities

Browse Leaves

Not provided

Browse Branches

Not provided