Persistent Low Back and Pelvic Pain 3-6 Months Post Partum

August 31, 2012 updated by: Helse Stavanger HF

Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum

The purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. They will then divide the females into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain will be invited to participate in a randomised controlled study where chiropractic intervention is compared to exercises.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a follow up study to "Prevalence of low back pain and pelvic pain in the pregnant population in Stavanger".

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, 4011
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Low back and\or pelvic girdle pain during pregnancy
  • Fluent understanding of spoken and written Norwegian

Exclusion Criteria:

  • hospitalisation due to pain or complications post partum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chiropractic treatment, exercise
Chiropractic treatment and exercise
Other: chiropractic treatment and exercises
Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments
Other Names:
  • Exercise
  • Manipulation
  • Pregnancy
  • Back pain
  • Post partum
  • chiropractic
Experimental: Exercises
Exercise advise
Other: exercise advise
Exercises
Other Names:
  • Exercise
  • Pregnancy
  • Back pain
  • Post partum
  • chiropractic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oswestry Disability Index
Time Frame: 20 weeks after the initial assessment
20 weeks after the initial assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

University of Stavanger

Investigators

  • Study Director: Jan P Larsen, MD Dr med, Helse Stavanger HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/798 (Other Identifier: Regional Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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