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
  Purpose

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.

Condition Intervention
Pelvic Girdle Pain
Other: Chiropractic
Other: Conventional medical intervention
Other: Conventional and alternative intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Pelvic Girdle Pain in a Pregnant Population in Western Norway - Incidence, Cumulative Prevalence, Course and Intervention.

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 650
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lumbopelvic pain
  • Pelvic pain
  • Performed ultrasound examination at 18th pregnancy week
  • Expected normal pregnancy without complications
  • Good competency in Norwegian language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098136

Locations
Norway
Stavanger University Hospital, Department of Obstetrics and Gynaecology
Stavanger, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
University of Stavanger
Investigators
Principal Investigator: Stefan Malmquist, DC MSc Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01098136     History of Changes
Other Study ID Numbers: 2010/174-4
Study First Received: March 22, 2010
Last Updated: August 30, 2012
Health Authority: Norway: Ethics Committee

Keywords provided by Helse Stavanger HF:
Pelvic girdle pain
Chiropractic
Single-blinded
Outcome study

ClinicalTrials.gov processed this record on July 22, 2014