Pelvic Girdle Pain in a Pregnant Population in Western Norway.

NCT ID: NCT01098136

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Pelvic Girdle Pain

Keywords

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Pelvic girdle pain Chiropractic Single-blinded Outcome study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Chiropractic treatment

Management for one-sided pelvic pain, as decided by the chiropractor

Group Type ACTIVE_COMPARATOR

Chiropractic

Intervention Type OTHER

Manual treatment of musculoskeletal complaints

Conventional health care

Conventional health care for one-sided pelvic pain

Group Type ACTIVE_COMPARATOR

Conventional medical intervention

Intervention Type OTHER

Medical, physiotherapy

Conventional and alternative treatment

Treament of pregnant women with other pelvic pain syndromes.

Group Type ACTIVE_COMPARATOR

Conventional and alternative intervention

Intervention Type OTHER

Medical and alternative methods for treatment of pelvic pain syndromes

Interventions

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Chiropractic

Manual treatment of musculoskeletal complaints

Intervention Type OTHER

Conventional medical intervention

Medical, physiotherapy

Intervention Type OTHER

Conventional and alternative intervention

Medical and alternative methods for treatment of pelvic pain syndromes

Intervention Type OTHER

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Stavanger

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Malmquist, DC MSc

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

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Stavanger University Hospital, Department of Obstetrics and Gynaecology

Stavanger, , Norway

Site Status

Countries

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Norway

References

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Gausel AM, Kjaermann I, Malmqvist S, Andersen K, Dalen I, Larsen JP, Okland I. Chiropractic management of dominating one-sided pelvic girdle pain in pregnant women; a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Sep 29;17(1):331. doi: 10.1186/s12884-017-1528-9.

Reference Type DERIVED
PMID: 28962596 (View on PubMed)

Other Identifiers

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2010/174-4

Identifier Type: -

Identifier Source: org_study_id