Pregnancy-related Low Back PainNCT02606786
Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
A study testing Lumbopelvic stabilization exercises in people with Pregnancy-related Low Back Pain, run by Texas Woman's University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy-related Low Back Pain
- What is being tested?
- Lumbopelvic stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Neurological signs
- Systemic disease
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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).
- Conditions
- Pregnancy-related Low Back Pain
- Being tested
- Lumbopelvic stabilization exercises
- Keywords
- stabilization exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbopelvic stabilization exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| stabilization exercises | Experimental | 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. Receives: Other: Lumbopelvic stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Oswestry Low Back Pain Questionnaire
Low back pain (LBP)-related disability
Measured: 4 weeks, 12 weeks
Secondary outcomes (3)
Numeric Pain Rating Scale
Pain intensity
Measured: 4 weeks, 12 weeks
Ultrasonographic measurements
Thickness of abdominal muscles at rest and with contraction
Measured: 4 weeks, 12 weeks
Participant perceived level of improvement
Subjective rating of change in response to treatment using the Global Rating of Change Scale (GROC)
Measured: 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Difficulty with participant recruitment and retainment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy-related Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelli Brizzolara, Texas Woman's University
- Investigators
- Kelli J Brizzolara, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606786
- Sponsor's protocol ID
- 17919
- Status last verified
- Sep 2017
- First submitted
- 18 Mar 2015
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
- ClinicalTrials.gov ID
- NCT02606786
- Acronym / sponsor ID
- 17919
- Conditions
- Pregnancy-related Low Back Pain
- Keywords
- stabilization exercises
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with participant recruitment and retainment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stabilization exercises | Experimental | Other: Lumbopelvic stabilization exercisesLumbopelvic 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Neurological signs
- Systemic disease
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbopelvic stabilization exercisesThe 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. | Other | stabilization exercises |
Primary outcome
Change in Modified Oswestry Low Back Pain Questionnaire
Time frame: 4 weeks, 12 weeks
Low back pain (LBP)-related disability
3 secondary outcomes
Numeric Pain Rating Scale
Time frame: 4 weeks, 12 weeks
Ultrasonographic measurements
Time frame: 4 weeks, 12 weeks
Participant perceived level of improvement
Time frame: 4 weeks, 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli J Brizzolara, PhD principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbopelvic stabilization exercises in people with Pregnancy-related Low Back Pain, run by Texas Woman's University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Oswestry Low Back Pain Questionnaire (time frame: 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.