Back to resultsPersistent Low Back and Pelvic Pain 3-6 Months Post Partum
Primary Purpose
Pelvic Girdle Pain Post Partum, Low Back Pain Post Partum
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
exercise advise
chiropractic treatment and exercises
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Girdle Pain Post Partum focused on measuring low back pain, pelvic pain, pelvic girdle pain, post partum
Eligibility 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
Sites / Locations
- Stavanger university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Chiropractic treatment, exercise
Exercises
Arm Description
Chiropractic treatment and exercise
Exercise advise
Outcomes
Primary Outcome Measures
Oswestry Disability Index
Secondary Outcome Measures
Full Information
NCT ID
NCT00974103
First Posted
September 9, 2009
Last Updated
August 31, 2012
Sponsor
Helse Stavanger HF
Collaborators
University of Stavanger
1. Study Identification
Unique Protocol Identification Number
NCT00974103
Brief Title
Persistent Low Back and Pelvic Pain 3-6 Months Post Partum
Official Title
Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
University of Stavanger
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The study is a follow up study to "Prevalence of low back pain and pelvic pain in the pregnant population in Stavanger".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain Post Partum, Low Back Pain Post Partum
Keywords
low back pain, pelvic pain, pelvic girdle pain, post partum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chiropractic treatment, exercise
Arm Type
Experimental
Arm Description
Chiropractic treatment and exercise
Arm Title
Exercises
Arm Type
Experimental
Arm Description
Exercise advise
Intervention Type
Other
Intervention Name(s)
exercise advise
Other Intervention Name(s)
Pregnancy, Back pain, Exercise, Post partum, chiropractic
Intervention Description
Exercises
Intervention Type
Other
Intervention Name(s)
chiropractic treatment and exercises
Other Intervention Name(s)
Manipulation, Pregnancy, Back pain, Exercise, Post partum, chiropractic
Intervention Description
Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Time Frame
20 weeks after the initial assessment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan P Larsen, MD Dr med
Organizational Affiliation
Helse Stavanger HF
Official's Role
Study Director
Facility Information:
Facility Name
Stavanger university hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Persistent Low Back and Pelvic Pain 3-6 Months Post Partum
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