Diaphragm Function in Low Back Pain People (LBP_DIA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain; Low Back Pain, Mechanical
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• Hungary
  • Csongrád-Csanád
    • Szeged, Csongrád-Csanád, Hungary, 6726
      • University of Szeged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female participants, over age 18, who were participated in the study voluntarily.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2021
• Primary Completion (ANTICIPATED): August 15, 2022
• Study Completion (ANTICIPATED): February 8, 2025

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (ACTUAL): August 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: LBP; diaphragm; MSK ultrasound
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LBP_DIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No