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Low Back PainPhase 2NCT00005771

The Use of Real Time Ultrasound Feedback in Teaching Abdominal Hollowing Exercises

A Phase 2 study testing Visual utrasound feedback and Abdominal Hollowing Exercise in people with Low Back Pain, run by National Center for Research Resources (NCRR) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Recently, physical therapists have begun treating people who have mechanical low back pain, hypothesized to be caused by segmental instability in the lumbar spine, with a very specific exercise program consisting of trunk stabilization exercises. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Visual utrasound feedback and Abdominal Hollowing Exercise
How many people
Not given
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Phase 2
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Vermont

    Burlington, Vermont, 05401

Other trials in United States

About this study

Recently, physical therapists have begun treating people who have mechanical low back pain, hypothesized to be caused by segmental instability in the lumbar spine, with a very specific exercise program consisting of trunk stabilization exercises. The theory behind the use of trunk stabilization exercises to treat lower back pain is that active contraction of the trunk local segmental muscles helps to control inter-segmental movement in the spine. The initial trunk stabilization exercise that physical therapists teach patients is an abdominal drawing in maneuver often called an abdominal hollowing exercise (AHE). A challenge for physical therapists is to establish the most effective means of teaching people to contract the relevant muscles needed to perform the AHE. The purpose of this study is to examine if supplementing the typical clinical instruction for teaching the AHE with visual ultrasound feedback to the patient is effective at reducing the length of time it takes an individual to learn to perform an AHE.

Three groups of research volunteers will be taught how to do the AHE while receiving different kinds of feedback about their performance in order to determine which type of feedback is most effective in assisting people to learn the AHE. Group 1 will not receive any feedback about performance; Group 2 will receive feedback from palpation and verbal descriptive alone; and Group 3 will receive feedback from palpation, verbal descriptive feedback, and real time ultrasound. For the initial test when subjects are learning the AHE, the number of trials until the subject demonstrates his/her third correct AHE will be the outcome variable. For the retention test, the outcome variable will be the percentage of trials (out of ten) of correctly performed AHEs in the absence of visual, verbal or palpation feedback.

Conditions
Low Back Pain
Being tested
Visual utrasound feedback, Abdominal Hollowing Exercise
Keywords
Abdominal Hollowing Exercises
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.

  • Visual utrasound feedbackDevice

  • Abdominal Hollowing ExerciseProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2000 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005771
Sponsor's protocol ID
NCRR-M01RR00109-0746
Other IDs
M01RR000109
Status last verified
Nov 2001
First submitted
1 Jun 2000
Last updated
24 Jun 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Visual utrasound feedback and Abdominal Hollowing Exercise in people with Low Back Pain, run by National Center for Research Resources (NCRR) 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 0 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?
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 24 Jun 2005.

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