search
Back to results

Pelvic Girdle Pain in a Pregnant Population in Western Norway.

Primary Purpose

Pelvic Girdle Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Chiropractic
Conventional medical intervention
Conventional and alternative intervention
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Girdle Pain focused on measuring Pelvic girdle pain, Chiropractic, Single-blinded, Outcome study

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Stavanger University Hospital, Department of Obstetrics and Gynaecology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Chiropractic treatment

Conventional health care

Conventional and alternative treatment

Arm Description

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

Conventional health care for one-sided pelvic pain

Treament of pregnant women with other pelvic pain syndromes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2010
Last Updated
August 30, 2012
Sponsor
Helse Stavanger HF
Collaborators
University of Stavanger
search

1. Study Identification

Unique Protocol Identification Number
NCT01098136
Brief Title
Pelvic Girdle Pain in a Pregnant Population in Western Norway.
Official Title
A Study of Pelvic Girdle Pain in a Pregnant Population in Western Norway - Incidence, Cumulative Prevalence, Course and Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
University of Stavanger

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
Keywords
Pelvic girdle pain, Chiropractic, Single-blinded, Outcome study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chiropractic treatment
Arm Type
Active Comparator
Arm Description
Management for one-sided pelvic pain, as decided by the chiropractor
Arm Title
Conventional health care
Arm Type
Active Comparator
Arm Description
Conventional health care for one-sided pelvic pain
Arm Title
Conventional and alternative treatment
Arm Type
Active Comparator
Arm Description
Treament of pregnant women with other pelvic pain syndromes.
Intervention Type
Other
Intervention Name(s)
Chiropractic
Intervention Description
Manual treatment of musculoskeletal complaints
Intervention Type
Other
Intervention Name(s)
Conventional medical intervention
Intervention Description
Medical, physiotherapy
Intervention Type
Other
Intervention Name(s)
Conventional and alternative intervention
Intervention Description
Medical and alternative methods for treatment of pelvic pain syndromes
Primary Outcome Measure Information:
Title
P4/thigh thrust
Description
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.
Time Frame
Outcome is assessed at follow-up examination 6 weeks post-partum
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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
Time Frame
Outcome is assessed at follow-up examination 6 weeks post-partum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lumbopelvic pain Pelvic pain Performed ultrasound examination at 18th pregnancy week Expected normal pregnancy without complications Good competency in Norwegian language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Malmquist, DC MSc
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital, Department of Obstetrics and Gynaecology
City
Stavanger
ZIP/Postal Code
4068
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28962596
Citation
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.
Results Reference
derived

Learn more about this trial

Pelvic Girdle Pain in a Pregnant Population in Western Norway.

We'll reach out to this number within 24 hrs