Low Back PainNCT04324242
Activating Transversus Abdominis Muscle
An observational study of Low Back Pain and Rehabilitative Ultrasound, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Rehabilitative Ultrasound, Spinal Stabilization
- What is being tested?
- abdominal hallowing maneuver
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2020to 15 Sep 2020
- Phase
- Observational
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers between ages of 18-25 with no spinal problems.
Who may be able to join
- healthy volunteers between ages of 18-25
Who cannot join
- Volunteers excluded if they had (1) history of LBP, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. Each volunteer gave their informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Çankaya, 06530
Esra Dülger, 05395821958, esradulger@hacettepe.edu.tr
About this study
Official title: Activating Transversus Abdominis Muscle: A Comparison Of Two Different Feedback Methods
Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Individuals with low back pain may have some troubles to understand proper contraction of TrA. Therefore, to contract the TrA, two different feedback techniques have been used to instruct. In this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of TrA muscle using ADIM. We aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.
- Being tested
- abdominal hallowing maneuver
- 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.
abdominal hallowing maneuverOther
abdominal hallowing maneuver includes tucking navel in and up. To be able to control the effect of breathing it was instructed to start the maneuver at the end of the expiration. During the maneuver it was instructed to focus on increasing the thickness of TrA without increasing the thickness of IO and EO
| Study group | Role | What they receive |
|---|---|---|
| Group1 | visual feedback Receives: Other: abdominal hallowing maneuver | |
| Group2 | traditional feedback Receives: Other: abdominal hallowing maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness change in TrA muscle
thickness change in TrA muscle
Measured: 1 month
Secondary outcomes (2)
thickness change in EO muscle
thickness change in EO muscle
Measured: 1 month
thickness change in IO muscle
thickness change in IO muscle
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start13 Apr 2020
- Primary completion30 Apr 2020
- Study completion15 Sep 2020 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Dülger, Hacettepe University
- Investigators
- Sevil Bilgin, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324242
- Sponsor's protocol ID
- GO 16/808
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Transversus Abdominis Muscle: A Comparison Of Two Different Feedback Methods
- ClinicalTrials.gov ID
- NCT04324242
- Acronym / sponsor ID
- GO 16/808
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 27 Mar 2020 (actual)
- 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.
Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Individuals with low back pain may have some troubles to understand proper contraction of TrA. Therefore, to contract the TrA, two different feedback techniques have been used to instruct. In this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of TrA muscle using ADIM. We aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Other: abdominal hallowing maneuvervisual feedback |
| Group2 | – | Other: abdominal hallowing maneuvertraditional feedback |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers between ages of 18-25 with no spinal problems.
Key inclusion criteria (1 listed)
- healthy volunteers between ages of 18-25
Key exclusion criteria (1 listed)
- Volunteers excluded if they had (1) history of LBP, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. Each volunteer gave their informed consent.
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 |
|---|---|---|
| abdominal hallowing maneuverabdominal hallowing maneuver includes tucking navel in and up. To be able to control the effect of breathing it was instructed to start the maneuver at the end of the expiration. During the maneuver it was instructed to focus on increasing the thickness of TrA without increasing the thickness of IO and EO | Other | Group1, Group2 |
Primary outcome
thickness change in TrA muscle
Time frame: 1 month
thickness change in TrA muscle
2 secondary outcomes
thickness change in EO muscle
Time frame: 1 month
thickness change in IO muscle
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Sevil Bilgin principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Rehabilitative Ultrasound, run by Hacettepe University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 12 Jun 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Dülger (+905395821958, esradulger@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness change in TrA muscle (time frame: 1 month). It is what the study was designed to measure, not a finding.
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 12 Jun 2020.