Low Back PainRedcord RUSINCT01015846
Ultrasound Assessment During Exercise
A study testing Exercise and Core stability exercise in people with Low Back Pain, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise and Core stability exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low back pain with stabilization classification
Who cannot join
- Fractures, neurological condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Assessment of Transverse Abdominis Muscle Function Associated With Stabilization Exercises in Low Back Pain Patients
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.
- Conditions
- Low Back Pain
- Being tested
- Exercise, Core stability exercise
- Keywords
- Core, Redcord, RUSI, low back
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Redcord (sling exercise) and traditional exercise
Core stability exerciseOther
Traditional core stability exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Exercise |
| Core stability exercise | Active comparator | Traditional core stability exercise Receives: Other: Core stability exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
TrA activation ratio measured by RUSI
Measured: Pre - during - post exercise during a single day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Susan Saliba, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015846
- Sponsor's protocol ID
- 14046
- Acronym
- Redcord RUSI
- Status last verified
- Nov 2009
- First submitted
- 28 Sep 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23160344
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transverse Abdominis Muscle Function Associated With Stabilization Exercises in Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT01015846
- Acronym / sponsor ID
- Redcord RUSI / 14046
- Conditions
- Low Back Pain
- Keywords
- Core, Redcord, RUSI, low back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise |
| Core stability exercise | Active comparator | Other: Core stability exerciseTraditional core stability exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Low back pain with stabilization classification
Key exclusion criteria (1 listed)
- Fractures, neurological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseRedcord (sling exercise) and traditional exercise | Other | Intervention |
| Core stability exerciseTraditional core stability exercise | Other | Core stability exercise |
Primary outcome
TrA activation ratio measured by RUSI
Time frame: Pre - during - post exercise during a single day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
- Derived from this study: PubMed 23160344Grooms 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Saliba principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Core stability exercise in people with Low Back Pain, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TrA activation ratio measured by RUSI (time frame: Pre - during - post exercise during a single day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2009.