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Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women

Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00298935
Enrollment
146
Registered
2006-03-03
Start date
2003-07-31
Completion date
2006-06-30
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Musculoskeletal Diseases, Pregnancy Complications

Keywords

Randomized Controlled Trial, Pregnant Women

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.

Interventions

PROCEDUREOsteopathic manipulative treatment (OMT)

Sponsors

Osteopathic Heritage Foundations
CollaboratorOTHER
University of North Texas Health Science Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Occurrence of premature labor and delivery as well as obstetrical complications during delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026