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Completed

NCT Number: NCT01098136

Pelvic Girdle Pain in a Pregnant Population in Western Norway.

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.

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Key information

Conditions

Pelvic Girdle Pain Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stavanger University Hospital, Department of Obstetrics and Gynaecology

Stavanger, 4068, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

chiropractic

Other

Manual treatment of musculoskeletal complaints

Conventional medical intervention

Other

Medical, physiotherapy

Conventional and alternative intervention

Other

Medical and alternative methods for treatment of pelvic pain syndromes

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • University of Stavanger

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2010
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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