Pelvic Girdle Pain in a Pregnant Population in Western Norway.

Study Overview
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Brief Summary
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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.

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

Conditions
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Pelvic Girdle Pain

Intervention / Treatment
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* Other: Chiropractic
* Other: Conventional medical intervention
* Other: Conventional and alternative intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lumbopelvic pain Pelvic pain Performed ultrasound examination at 18th pregnancy week Expected normal pregnancy without complications Good competency in Norwegian language
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chiropractic treatment<br>Management for one-sided pelvic pain, as decided by the chiropractor | Other: Chiropractic<br>* Manual treatment of musculoskeletal complaints<br>|
| Active Comparator: Conventional health care<br>Conventional health care for one-sided pelvic pain | Other: Conventional medical intervention<br>* Medical, physiotherapy<br>|
| Active Comparator: Conventional and alternative treatment<br>Treament of pregnant women with other pelvic pain syndromes. | Other: Conventional and alternative intervention<br>* Medical and alternative methods for treatment of pelvic pain syndromes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic girdle pain, Chiropractic, Single-blinded, Outcome study