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

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 Overview

• Status: Withdrawn
• Conditions: Pregnancy-related Low Back Pain
• Intervention / Treatment: Other: Lumbopelvic stabilization exercises

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Texas Woman's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: stabilization exercises; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	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)	4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Investigators: Principal Investigator: Kelli J Brizzolara, PhD, Texas Woman's University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (ESTIMATE): November 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: stabilization exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 17919