Effectiveness of Lumbopelvic Stabilization Exercises for... | NCT02606786

Studies
Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain

NCT02606786

Sponsor

Texas Woman's University

Status

Withdrawn

Last Update Posted

Sep 7, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Pregnancy-related Low Back Pain

Interventions

Lumbopelvic stabilization exercises

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty with participant recruitment and retainment

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Mar 18, 2015

First Submission Date that Met QC Criteria

Nov 13, 2015

First Posted Date

Nov 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2017

Last Update Posted Date

Sep 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kelli Brizzolara, Assistant Professor, Texas Woman's UniversityPrincipal Investigator

Lead Sponsor

Texas Woman's UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Lumbopelvic stabilization exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumbopelvic stabilization exercises	Other	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 Module

Primary Outcomes

Measure	Description	Time Frame
Change in Modified Oswestry Low Back Pain Questionnaire	Low back pain (LBP)-related disability	4 weeks, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Numeric Pain Rating Scale	Pain intensity	4 weeks, 12 weeks
Ultrasonographic measurements	Thickness of abdominal muscles at rest and with contraction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kelli J Brizzolara, PhD	Texas Woman's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Woman's University		Dallas	Texas	75235	United States