NCT01015846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

6 months

First QC Date

September 28, 2009

Last Update Submit

November 16, 2009

Conditions

Low Back Pain

Keywords

CoreRedcordRUSIlow back

Outcome Measures

Primary Outcomes (1)

  • TrA activation ratio measured by RUSI

    Pre - during - post exercise during a single day

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Exercise

Core stability exercise

ACTIVE COMPARATOR

Traditional core stability exercise

Other: Core stability exercise

Interventions

ExerciseOTHER

Redcord (sling exercise) and traditional exercise

Intervention
Core stability exerciseOTHER

Traditional core stability exercise

Core stability exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Low back pain with stabilization classification

You may not qualify if:

  • Fractures, neurological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • 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.

    PMID: 23160344DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Susan Saliba

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2009

First Posted

November 18, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

US(1)