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

This study has been completed.
Sponsor:
Collaborator:
University of Stavanger
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00974103
First received: September 9, 2009
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Pelvic Girdle Pain Post Partum
Low Back Pain Post Partum
 Other: exercise advise
Other: chiropractic treatment and exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 20 weeks after the initial assessment ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Manipulation
  • Pregnancy
  • Back pain
  • Exercise
  • Post partum
  • chiropractic
Experimental: Exercises
Exercise advise
 Other: exercise advise
Exercises
Other Names:
  • Pregnancy
  • Back pain
  • Exercise
  • Post partum
  • chiropractic

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974103

Locations
Norway
Stavanger university hospital
Stavanger, Norway, 4011
Sponsors and Collaborators
Helse Stavanger HF
University of Stavanger
Investigators
Study Director: Jan P Larsen, MD Dr med Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00974103     History of Changes
Other Study ID Numbers: 2009/798, 2009/798
Study First Received: September 9, 2009
Last Updated: August 31, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Helse Stavanger HF:
low back pain
pelvic pain
pelvic girdle pain
post partum

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pelvic Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013