Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
Primary Purpose
Pregnancy-related Low Back Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbopelvic stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy-related Low Back Pain focused on measuring stabilization exercises
Eligibility Criteria
Inclusion Criteria:
- Unilateral low back pain near the sacro-iliac joint (SIJ) (distal and/or lateral to L5-S1 in the buttocks) and/or symphysis pubis
- Pain onset during pregnancy or within 3 weeks of delivery
- Most recent delivery within 6-24 weeks
- At least 2/6 positive SIJ provocation tests (thigh thrust, sacral compression, sacral distraction, sacral thrust, Gaenslen's test)
- Positive active straight leg raise (ASLR) test.
Exclusion Criteria:
- Neurological signs
- Systemic disease
- Currently pregnant
Sites / Locations
- Texas Woman's University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stabilization exercises
Arm Description
Lumbopelvic stabilization exercises have been shown to decrease pain and disability in those with low back pain. The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine.
Outcomes
Primary Outcome Measures
Change in Modified Oswestry Low Back Pain Questionnaire
Low back pain (LBP)-related disability
Secondary Outcome Measures
Numeric Pain Rating Scale
Pain intensity
Ultrasonographic measurements
Thickness of abdominal muscles at rest and with contraction
Participant perceived level of improvement
Subjective rating of change in response to treatment using the Global Rating of Change Scale (GROC)
Full Information
NCT ID
NCT02606786
First Posted
March 18, 2015
Last Updated
September 6, 2017
Sponsor
Texas Woman's University
1. Study Identification
Unique Protocol Identification Number
NCT02606786
Brief Title
Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
Official Title
Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty with participant recruitment and retainment
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effectiveness of lumbopelvic stabilization exercises on women who have undergone Caesarian sections on: 1) disability using the Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).
Detailed Description
Pregnancy-related low back pain is a very complex problem. Decreased strength and endurance in the trunk and hip muscles have been shown in those with pregnancy-related low back pain. Lumbopelvic stabilization exercises have been shown to decrease pain and disability in those with low back pain. However, there have been very few studies with post-partum women, specifically those who have undergone Caesarian section births.
The purpose of this study is to examine the effectiveness of lumbopelvic stabilization exercises on women who have undergone Caesarian sections on: 1) disability using the Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy-related Low Back Pain
Keywords
stabilization exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stabilization exercises
Arm Type
Experimental
Arm Description
Lumbopelvic stabilization exercises have been shown to decrease pain and disability in those with low back pain. The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine.
Intervention Type
Other
Intervention Name(s)
Lumbopelvic stabilization exercises
Intervention Description
The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine.
Primary Outcome Measure Information:
Title
Change in Modified Oswestry Low Back Pain Questionnaire
Description
Low back pain (LBP)-related disability
Time Frame
4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Pain intensity
Time Frame
4 weeks, 12 weeks
Title
Ultrasonographic measurements
Description
Thickness of abdominal muscles at rest and with contraction
Time Frame
4 weeks, 12 weeks
Title
Participant perceived level of improvement
Description
Subjective rating of change in response to treatment using the Global Rating of Change Scale (GROC)
Time Frame
4 weeks, 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Unilateral low back pain near the sacro-iliac joint (SIJ) (distal and/or lateral to L5-S1 in the buttocks) and/or symphysis pubis
Pain onset during pregnancy or within 3 weeks of delivery
Most recent delivery within 6-24 weeks
At least 2/6 positive SIJ provocation tests (thigh thrust, sacral compression, sacral distraction, sacral thrust, Gaenslen's test)
Positive active straight leg raise (ASLR) test.
Exclusion Criteria:
Neurological signs
Systemic disease
Currently pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli J Brizzolara, PhD
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
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