LBP_DIA: Diaphragm Function in Low Back Pain People

Sponsor
Szeged University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05486858
Collaborator
(none)
350
1
48
7.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: MSK ultrasonograpy
  • Other: sitting Functional and Lateral Reach Test

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

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Differencies in the Contraction Ratio of Diaphragm Muscle Between Low Back Pain and Asymptomatic Individuals.
Actual Study Start Date :
Feb 8, 2021
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Feb 8, 2025

Arms and Interventions

Arm Intervention/Treatment
LBP individuals

People who suffer from pain in the lower back area.

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.

Other: 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.

asymptomatic individuals

People who has no low back pain in the patient history.

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. MSK ultrasonography [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.

  2. sitting Functional and Lateral Reach Test [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.

Secondary Outcome Measures

  1. Visual analogue scale [1 min]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Szeged Szeged Csongrád-Csanád Hungary 6726

Sponsors and Collaborators

  • Szeged University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Szeged University
ClinicalTrials.gov Identifier:
NCT05486858
Other Study ID Numbers:
  • LBP_DIA
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Szeged University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022