NCT00905112

Brief Summary

The investigators propose such a trial to compare a Musculoskeletal and Obstetric Management (MOM) program to standard obstetric care alone for lower back pain/pelvic pain (LBP/PP) during and after pregnancy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

October 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 20, 2009

Status Verified

May 1, 2009

Enrollment Period

2.7 years

First QC Date

May 18, 2009

Last Update Submit

May 19, 2009

Conditions

Lower Back PainPelvic PainMusculoskeletal Pain

Keywords

PregnancyPainMusculoskeletal manipulationsExercise

Outcome Measures

Primary Outcomes (1)

  • Quebec Task Force Disability Scale Questionnaire (QDQ)

    Baseline, 33 weeks of gestation and 3 months postpartum

Secondary Outcomes (9)

  • Numerical Rating Scale (NRS)

    Baseline, 33 weeks of gestation and 3 months postpartum

  • Personal Pain History (PPH)

    Baseline, 33 weeks of gestation and 3 months postpartum

  • Straight Leg Raise (SLR)

    Baseline, 33 weeks of gestation and 3 months postpartum

  • Active Straight Leg Raise (ASLR)

    Baseline, 33 weeks of gestation and 3 months postpartum

  • Long Dorsal Ligament Test (LDLT)

    Baseline, 33 weeks of gestation and 3 months postpartum

  • +4 more secondary outcomes

Study Arms (2)

MOMS

EXPERIMENTAL

Receives manual therapy, stabilization exercise and patient education

Other: Manual Therapy

STOB

ACTIVE COMPARATOR

Receive standard obstetrical care

Other: Standard OB Care

Interventions

Manual TherapyOTHER

Receives manual therapy, stabilization exercise and patient education

MOMS
Standard OB CareOTHER

Receive standard obstetrical care

STOB

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female Patients 15-45 years of age
  • Pregnant - 24-28 weeks gestation
  • LBP and/or PP

You may not qualify if:

  • History of fracture, neoplasm, previous surgery of lumbar spine, pelvis, hip or femur
  • Acute inflammatory or infectious disease
  • Chronic pain prior to pregnancy (pain persisting for \> 8 weeks prior to pregnancy)
  • Mental health disorder requiring medication/treatment
  • Back pain from visceral diseases
  • Peripheral vascular disease and/or cardiac disease requiring medical treatment
  • Severe disabling health problems
  • Substance abuse
  • Ongoing treatment for back pain by other health care providers
  • Pending or current litigation
  • Multiple birth pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Center for Advanced Medicine

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

MeSH Terms

Conditions

Low Back PainPelvic PainMusculoskeletal PainPainMotor Activity

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

October 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 20, 2009

Record last verified: 2009-05

Locations

US(3)