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Trial record 1 of 1 for:    01098136
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Pelvic Girdle Pain in a Pregnant Population in Western Norway.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01098136
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : August 31, 2012
University of Stavanger
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:

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 or disease Intervention/treatment Phase
Pelvic Girdle Pain Other: Chiropractic Other: Conventional medical intervention Other: Conventional and alternative intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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.
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01098136

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Stavanger University Hospital, Department of Obstetrics and Gynaecology
Stavanger, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
University of Stavanger
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Principal Investigator: Stefan Malmquist, DC MSc Helse Stavanger HF
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Helse Stavanger HF Identifier: NCT01098136    
Other Study ID Numbers: 2010/174-4
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012
Keywords provided by Helse Stavanger HF:
Pelvic girdle pain
Outcome study
Additional relevant MeSH terms:
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Pelvic Girdle Pain
Musculoskeletal Pain
Neurologic Manifestations
Signs and Symptoms
Pelvic Pain