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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

September 9, 2009
August 31, 2012
September 2009
August 2010   (final data collection date for primary outcome measure)
Oswestry Disability Index [ Time Frame: 20 weeks after the initial assessment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00974103 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Persistent Low Back and Pelvic Pain 3-6 Months Post Partum
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pelvic Girdle Pain Post Partum
  • Low Back Pain Post Partum
  • Other: exercise advise
    Exercises
    Other Names:
    • Pregnancy
    • Back pain
    • Exercise
    • Post partum
    • chiropractic
  • 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: Chiropractic treatment, exercise
    Chiropractic treatment and exercise
    Intervention: Other: chiropractic treatment and exercises
  • Experimental: Exercises
    Exercise advise
    Intervention: Other: exercise advise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Female
16 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00974103
2009/798, 2009/798
No
Helse Stavanger HF
Helse Stavanger HF
University of Stavanger
Study Director: Jan P Larsen, MD Dr med Helse Stavanger HF
Helse Stavanger HF
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP