Pelvic Girdle Pain in a Pregnant Population in Western Norway.

Pelvic Girdle Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098136
• Other study ID #: 2010/174-4
• Status: Completed
• Phase: N/A
• First received: March 22, 2010
• Last updated: August 30, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Lumbopelvic pain

• Pelvic pain

• Performed ultrasound examination at 18th pregnancy week

• Expected normal pregnancy without complications

• Good competency in Norwegian language

Study Design

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

Related Conditions & MeSH terms

• Pelvic Girdle Pain

Intervention

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

Locations

Country	Name	City	State
Norway	Stavanger University Hospital, Department of Obstetrics and Gynaecology	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	University of Stavanger

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P4/thigh thrust	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	No
Secondary	Oswestry Disability Index	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	No