Pelvic Girdle Pain in a Pregnant Population in Western Norway.

Not Applicable

Completed

• Conditions: Pelvic Girdle Pain
• Interventions: Other: Chiropractic; Other: Conventional medical intervention; Other: Conventional and alternative intervention

• Registration Number: NCT01098136
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-04-01
• Study First Posted: 2010-04-02
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-30
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 650

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chiropractic treatment	Chiropractic	Management for one-sided pelvic pain, as decided by the chiropractor
Conventional health care	Conventional medical intervention	Conventional health care for one-sided pelvic pain
Conventional and alternative treatment	Conventional and alternative intervention	Treament of pregnant women with other pelvic pain syndromes.

Primary Outcome Measures

Name	Time	Method
P4/thigh thrust	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

Name	Time	Method
Oswestry Disability Index	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

Trial Locations

Locations (1)

Stavanger University Hospital, Department of Obstetrics and Gynaecology; 🇳🇴 Stavanger, Norway