Diaphragm Function in Low Back Pain People

Low Back Pain Clinical Trial

— LBP_DIA  

Official title:

Differencies in the Contraction Ratio of Diaphragm Muscle Between Low Back Pain and Asymptomatic Individuals.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05486858
• Other study ID #: LBP_DIA
• Status: Active, not recruiting
• Start date: February 8, 2021
• Est. completion date: February 8, 2025

Study information

• Verified date: August 2022
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: February 8, 2025
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• capable to get the scene of the measurements
• age is over 18

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Other:
• MSK ultrasonograpy
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 Test
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.

Locations

Country	Name	City	State
Hungary	University of Szeged	Szeged	Csongrád-Csanád

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 min
Primary	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.	5 min
Secondary	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.	1 min