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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974103
First Posted: September 10, 2009
Last Update Posted: September 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Stavanger
Information provided by (Responsible Party):
Helse Stavanger HF
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 20 weeks after the initial assessment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00974103     History of Changes
Other Study ID Numbers: 2009/798
2009/798 ( Other Identifier: Regional Ethics Committee )
First Submitted: September 9, 2009
First Posted: September 10, 2009
Last Update Posted: September 3, 2012
Last Verified: August 2012

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
Pelvic Girdle Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Pain