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Ultrasound Assessment During Exercise (Redcord RUSI)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Core stability exercise
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Core, Redcord, RUSI, low back

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Low back pain with stabilization classification

Exclusion Criteria:

  • Fractures, neurological condition

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Core stability exercise

Arm Description

Traditional core stability exercise

Outcomes

Primary Outcome Measures

TrA activation ratio measured by RUSI

Secondary Outcome Measures

Full Information

First Posted
September 28, 2009
Last Updated
November 16, 2009
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT01015846
Brief Title
Ultrasound Assessment During Exercise
Acronym
Redcord RUSI
Official Title
Assessment of Transverse Abdominis Muscle Function Associated With Stabilization Exercises in Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the ability of the transverse abdominis (TrA) to contract during and after two different types of exercise - either sling based exercise or traditional core stability exercise. The TrA is measured by real time ultrasound imaging. The investigators hypothesized that the sling based exercise would activate the TrA to a greater degree and that there would be a greater activation after the exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Core, Redcord, RUSI, low back

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Core stability exercise
Arm Type
Active Comparator
Arm Description
Traditional core stability exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Redcord (sling exercise) and traditional exercise
Intervention Type
Other
Intervention Name(s)
Core stability exercise
Intervention Description
Traditional core stability exercise
Primary Outcome Measure Information:
Title
TrA activation ratio measured by RUSI
Time Frame
Pre - during - post exercise during a single day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Low back pain with stabilization classification Exclusion Criteria: Fractures, neurological condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Saliba
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23160344
Citation
Grooms DR, Grindstaff TL, Croy T, Hart JM, Saliba SA. Clinimetric analysis of pressure biofeedback and transversus abdominis function in individuals with stabilization classification low back pain. J Orthop Sports Phys Ther. 2013 Mar;43(3):184-93. doi: 10.2519/jospt.2013.4397. Epub 2012 Nov 16.
Results Reference
derived

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Ultrasound Assessment During Exercise

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