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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 11, 2014