NCT01098136

Brief Summary

The objectives in this study are

  1. 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. 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. 3.to investigate possible predictors for treatment outcome in one-sided PGP in pregnant women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

March 22, 2010

Last Update Submit

August 30, 2012

Conditions

Pelvic Girdle Pain

Keywords

Pelvic girdle painChiropracticSingle-blindedOutcome study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Oswestry Disability Index

    Outcome is assessed at follow-up examination 6 weeks post-partum

Study Arms (3)

Chiropractic treatment

ACTIVE COMPARATOR

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

Other: Chiropractic

Conventional health care

ACTIVE COMPARATOR

Conventional health care for one-sided pelvic pain

Other: Conventional medical intervention

Conventional and alternative treatment

ACTIVE COMPARATOR

Treament of pregnant women with other pelvic pain syndromes.

Other: Conventional and alternative intervention

Interventions

ChiropracticOTHER

Manual treatment of musculoskeletal complaints

Chiropractic treatment
Conventional medical interventionOTHER

Medical, physiotherapy

Conventional health care
Conventional and alternative interventionOTHER

Medical and alternative methods for treatment of pelvic pain syndromes

Conventional and alternative treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital, Department of Obstetrics and Gynaecology

Stavanger, 4068, Norway

Location

Related Publications (1)

  • 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.

    PMID: 28962596DERIVED

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Manipulation, ChiropracticCongresses as Topic

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsOrganizationsHealth Care Economics and Organizations

Study Officials

  • Stefan Malmquist, DC MSc

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2010

First Posted

April 2, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

NO(1)