Pelvic Girdle Pain in a Pregnant Population in Western Norway.

August 30, 2012 updated by: Helse Stavanger HF

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

The objectives in this study are

  1. 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.
  2. 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.
  3. to investigate possible predictors for treatment outcome in one-sided PGP in pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, 4068
        • Stavanger University Hospital, Department of Obstetrics and Gynaecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chiropractic treatment
Management for one-sided pelvic pain, as decided by the chiropractor
Other: Chiropractic
Manual treatment of musculoskeletal complaints
Active Comparator: Conventional health care
Conventional health care for one-sided pelvic pain
Other: Conventional medical intervention
Medical, physiotherapy
Active Comparator: Conventional and alternative treatment
Treament of pregnant women with other pelvic pain syndromes.
Other: Conventional and alternative intervention
Medical and alternative methods for treatment of pelvic pain syndromes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P4/thigh thrust
Time Frame: Outcome is assessed at follow-up examination 6 weeks post-partum
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.
Outcome is assessed at follow-up examination 6 weeks post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: Outcome is assessed at follow-up examination 6 weeks post-partum
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
Outcome is assessed at follow-up examination 6 weeks post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

University of Stavanger

Investigators

  • Principal Investigator: Stefan Malmquist, DC MSc, Helse Stavanger HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Estimate)

August 31, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/174-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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