Pelvic Girdle Pain in a Pregnant Population in Western Norway.

This study has been completed.

Sponsor:

Collaborator:

University of Stavanger

Information provided by (Responsible Party):

Helse Stavanger HF

ClinicalTrials.gov Identifier:

NCT01098136

First received: March 22, 2010

Last updated: August 30, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2010

Last Updated Date

August 30, 2012

Start Date ^ICMJE

March 2010

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

P4/thigh thrust [ Time Frame: Outcome is assessed at follow-up examination 6 weeks post-partum ] [ Designated as safety issue: No ]

As outcome measures we are using pain provocation tests (P4/thigh thrust, Patrick's Faber, Gaenslen's test, and modified Trendelenburg's test), pain palpation tests (long dorsal ligament test and palpation of the symphysis), and a functional test, the active straight leg raise (ASLR) test. All tests are published and described in European guidelines on pelvic girdle pain (PGP). Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. Epub 2008 Feb 8.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01098136 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Oswestry Disability Index [ Time Frame: Outcome is assessed at follow-up examination 6 weeks post-partum ] [ Designated as safety issue: No ]

The Oswestry Disability Index is one of the principal condition-specific outcome measures the last 30 years for management of disabling effects from spinal disorders

Original Secondary Outcome Measures ^ICMJE

Oswestry Disability Index [ Time Frame: Outcome is assessed at follow-up examination 6 weeks post partum ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pelvic Girdle Pain in a Pregnant Population in Western Norway.

Official Title ^ICMJE

A Study of Pelvic Girdle Pain in a Pregnant Population in Western Norway - Incidence, Cumulative Prevalence, Course and Intervention.

Brief Summary

The objectives in this study are

to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6 weeks after delivery.
to examine the outcome of chiropractic management for a dominating one-sided PGP subgroup of pregnant women in a single-blinded controlled study, and to use efficacy measures that include pain, functional impairment, and sick-leave frequency.
to investigate possible predictors for treatment outcome in one-sided PGP in pregnant women.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pelvic Girdle Pain

Intervention ^ICMJE

Other: Chiropractic
Manual treatment of musculoskeletal complaints
Other: Conventional medical intervention
Medical, physiotherapy
Other: Conventional and alternative intervention
Medical and alternative methods for treatment of pelvic pain syndromes

Study Arm (s)

Active Comparator: Chiropractic treatment
Management for one-sided pelvic pain, as decided by the chiropractor

Intervention: Other: Chiropractic
Active Comparator: Conventional health care
Conventional health care for one-sided pelvic pain

Intervention: Other: Conventional medical intervention
Active Comparator: Conventional and alternative treatment
Treament of pregnant women with other pelvic pain syndromes.

Intervention: Other: Conventional and alternative intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

650

Completion Date

December 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Lumbopelvic pain
Pelvic pain
Performed ultrasound examination at 18th pregnancy week
Expected normal pregnancy without complications
Good competency in Norwegian language

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01098136

Other Study ID Numbers ^ICMJE

2010/174-4

Has Data Monitoring Committee

Responsible Party

Helse Stavanger HF

Study Sponsor ^ICMJE

Helse Stavanger HF

Collaborators ^ICMJE

University of Stavanger

Investigators ^ICMJE

Principal Investigator:

Stefan Malmquist, DC MSc

Helse Stavanger HF

Information Provided By

Helse Stavanger HF

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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