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.
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
- Type of treatment
- Medical device, Surgery or procedure
- 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.
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.
- First posted2 Jun 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Real Time Ultrasound Feedback in Teaching Abdominal Hollowing Exercises
- ClinicalTrials.gov ID
- NCT00005771
- Acronym / sponsor ID
- NCRR-M01RR00109-0746
- Conditions
- Low Back Pain
- Keywords
- Abdominal Hollowing Exercises
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 2 Jun 2000 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Visual utrasound feedback | Device | – |
| Abdominal Hollowing Exercise | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.