Pelvic Girdle Pain in a Pregnant Population in Western Norway.
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|ClinicalTrials.gov Identifier: NCT01098136|
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : August 31, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Girdle Pain||Other: Chiropractic Other: Conventional medical intervention Other: Conventional and alternative intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||650 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: Chiropractic treatment
Management for one-sided pelvic pain, as decided by the chiropractor
Manual treatment of musculoskeletal complaints
Active Comparator: Conventional health care
Conventional health care for one-sided pelvic pain
Other: Conventional medical intervention
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
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01098136
|Stavanger University Hospital, Department of Obstetrics and Gynaecology|
|Stavanger, Norway, 4068|
|Principal Investigator:||Stefan Malmquist, DC MSc||Helse Stavanger HF|