Low Back PainLBP_DIANCT05486858
Diaphragm Function in Low Back Pain People
An observational study of Low Back Pain and Low Back Pain, Mechanical, run by Szeged University at 1 site in Hungary.
Trial summary
Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Low Back Pain, Mechanical
- What is being tested?
- MSK ultrasonograpy and sitting Functional and Lateral Reach Test
- How many people
- 350 participants
- Where
- 1 siteHungary
- Study dates
- 8 Feb 2021to 8 Feb 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female participants, over age 18, who were participated in the study voluntarily.
Who may be able to join
- capable to get the scene of the measurements
- age is over 18
Who cannot join
- serious neurologycal disorder, which affects the performance on the functional tests
- previous surgical intervention which has been affected the trunk
- intensive pain, which prevent the individual to perform the needed positions (supine and sitting)
- serious lung disease or breathing disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differencies in the Contraction Ratio of Diaphragm Muscle Between Low Back Pain and Asymptomatic Individuals.
Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. Postural function of diaphragm was screened in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured and contraction ratio was calculated. Additionally, the stability limits of the trunk were measured. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.
Read the detailed description
Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. The postural function of diaphragm was screened with Zonare Zone Ultrasound System in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured by using an elecric caliper of the ultrasound device and the contraction ratio was calculated. Additionally, the stability limits of the trunk were measured with sitting functional reach and sitting lateral reach tests. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.
- Conditions
- Low Back Pain, Low Back Pain, Mechanical
- Being tested
- MSK ultrasonograpy, sitting Functional and Lateral Reach Test
- Keywords
- LBP, diaphragm, MSK ultrasound
- 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.
MSK ultrasonograpyOther
MSK ultrasonography was used to measure the thickness of diaphragm muscle in supine and sitting position and in a relaxed and in a contracted state.
sitting Functional and Lateral Reach TestOther
Sitting reach tests were used to measure the stability limits of the trunk in different directions. Functional reach test is for testing the forward direction and lateral reach tests are for testing the right and the left directions.
| Study group | Role | What they receive |
|---|---|---|
| LBP individuals | People who suffer from pain in the lower back area. Receives: Other: MSK ultrasonograpy; Other: sitting Functional and Lateral Reach Test | |
| asymptomatic individuals | People who has no low back pain in the patient history. Receives: Other: MSK ultrasonograpy; Other: sitting Functional and Lateral Reach Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSK ultrasonography
An imaging procedure that allows doctors, physiotherapist to see muscles, joints, and more. For diagnosing muscle tears/strains, nerves, and arthritis. Physical therapy or injection of medicine may be next step. Involves radiology and center for musculoskeletal care.
In our study, the thickness of diaphragm muscle was measured in supine and sitting positions. Its contraction ratio was calculated, based on the relaxed and the contracted states of the muscle.
Measured: 20 min
sitting Functional and Lateral Reach Test
Special functional tests for testing the stability limits of the trunk. These are measured in sitting position, with the feet on the ground and without any support. The induvidual has to lean forward/right/left directions with forward stretched arms. We calculated the distance between the start and end positions of the fingers.
Measured: 5 min
Secondary outcomes (1)
Visual analogue scale
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. VAS is the most common pain scale. We ask the participants to indicate with the visual analogue scale the intensity of low back pain.
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start8 Feb 2021
- Primary completion15 Aug 2022 (estimated)
- Study completion8 Feb 2025 (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-control
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486858
- Sponsor's protocol ID
- LBP_DIA
- Acronym
- LBP_DIA
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differencies in the Contraction Ratio of Diaphragm Muscle Between Low Back Pain and Asymptomatic Individuals.
- ClinicalTrials.gov ID
- NCT05486858
- Acronym / sponsor ID
- LBP_DIA / LBP_DIA
- Conditions
- Low Back Pain, Low Back Pain, Mechanical
- Keywords
- LBP, diaphragm, MSK ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 8 Feb 2025 (estimated)
- First posted
- 4 Aug 2022 (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.
Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. Postural function of diaphragm was screened in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured and contraction ratio was calculated. Additionally, the stability limits of the trunk were measured. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.
Detailed description
Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. The postural function of diaphragm was screened with Zonare Zone Ultrasound System in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured by using an elecric caliper of the ultrasound device and the contraction ratio was calculated. Additionally, the stability limits of the trunk were measured with sitting functional reach and sitting lateral reach tests. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBP individuals | – | Other: MSK ultrasonograpy, Other: sitting Functional and Lateral Reach TestPeople who suffer from pain in the lower back area. |
| asymptomatic individuals | – | Other: MSK ultrasonograpy, Other: sitting Functional and Lateral Reach TestPeople who has no low back pain in the patient history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female participants, over age 18, who were participated in the study voluntarily.
Key inclusion criteria (2 listed)
- capable to get the scene of the measurements
- age is over 18
Key exclusion criteria (4 listed)
- serious neurologycal disorder, which affects the performance on the functional tests
- previous surgical intervention which has been affected the trunk
- intensive pain, which prevent the individual to perform the needed positions (supine and sitting)
- serious lung disease or breathing disorder
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 |
|---|---|---|
| MSK ultrasonograpyMSK ultrasonography was used to measure the thickness of diaphragm muscle in supine and sitting position and in a relaxed and in a contracted state. | Other | LBP individuals, asymptomatic individuals |
| sitting Functional and Lateral Reach TestSitting reach tests were used to measure the stability limits of the trunk in different directions. Functional reach test is for testing the forward direction and lateral reach tests are for testing the right and the left directions. | Other | LBP individuals, asymptomatic individuals |
Primary outcome
MSK ultrasonography
Time frame: 20 min
An imaging procedure that allows doctors, physiotherapist to see muscles, joints, and more. For diagnosing muscle tears/strains, nerves, and arthritis. Physical therapy or injection of medicine may be next step. Involves radiology and center for musculoskeletal care. In our study, the thickness of diaphragm muscle was measured in supine and sitting positions. Its contraction ratio was calculated, based on the relaxed and the contracted states of the muscle.
sitting Functional and Lateral Reach Test
Time frame: 5 min
Special functional tests for testing the stability limits of the trunk. These are measured in sitting position, with the feet on the ground and without any support. The induvidual has to lean forward/right/left directions with forward stretched arms. We calculated the distance between the start and end positions of the fingers.
1 secondary outcome
Visual analogue scale
Time frame: 1 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Low Back Pain and Low Back Pain, Mechanical, run by Szeged University at 1 site in Hungary.
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 2 inclusion and 4 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 4 Aug 2022. 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 Hungary. 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?
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?
MSK ultrasonography (time frame: 20 min). The study lists 2 primary outcomes in all. 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 4 Aug 2022.