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

Pregnancy-related Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02606786
• Other study ID #: 17919
• Status: Withdrawn
• Phase: N/A
• First received: March 18, 2015
• Last updated: September 6, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2017
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pregnancy-related Low Back Pain

Intervention

Other:
• Lumbopelvic stabilization exercises
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.

Locations

Country	Name	City	State
United States	Texas Woman's University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Oswestry Low Back Pain Questionnaire	Low back pain (LBP)-related disability	4 weeks, 12 weeks
Secondary	Numeric Pain Rating Scale	Pain intensity	4 weeks, 12 weeks
Secondary	Ultrasonographic measurements	Thickness of abdominal muscles at rest and with contraction	4 weeks, 12 weeks
Secondary	Participant perceived level of improvement	Subjective rating of change in response to treatment using the Global Rating of Change Scale (GROC)	4 weeks, 12 weeks