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

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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2011

Detailed Clinical Trial Description

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

Intervention(s) in this Clinical Trial

  • Other: exercise advise
    • Exercises
  • Other: chiropractic treatment and exercises
    • Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Chiropractic treatment, exercise
    • Chiropractic treatment and exercise
  • Experimental: Exercises
    • Exercise advise

Outcome Measures for this Clinical Trial

Primary Measures

  • Oswestry Disability Index
    • Time Frame: 20 weeks after the initial assessment
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Helse Stavanger HF Other

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Inger W Kjaermann, MSc. DC 004795220540 ikjaermann@yahoo.no

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00974103

Study ID Number: 2009/798

ClinicalTrials.gov Identifier: NCT00974103

Health Authority: Norway: Ethics Committee

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00974103