NCT00298935

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for phase_2 low-back-pain

Timeline
Completed

Started Jul 2003

Typical duration for phase_2 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

July 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

First QC Date

March 2, 2006

Last Update Submit

June 21, 2013

Conditions

Low Back PainMusculoskeletal DiseasesPregnancy Complications

Keywords

Randomized Controlled TrialPregnant Women

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Occurrence of premature labor and delivery as well as obstetrical complications during delivery

Interventions

Osteopathic manipulative treatment (OMT)PROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Third trimester pregnancy

You may not qualify if:

  • High risk pregnancy
  • Previous use of chiropractic manipulation, osteopathic manipulative treatment (OMT), physical therapy, or therapeutic ultrasound during the current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osteopathic Research Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Low Back PainMusculoskeletal DiseasesPregnancy Complications

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • John C. Licciardone, D.O., M.S.

    Osteopathic Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 3, 2006

Study Start

July 1, 2003

Study Completion

June 1, 2006

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

US(1)