Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

Study Overview
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Brief Summary
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Recently, it has been reported that the thoracolumbar fascia may play a role in the pathophysiology of chronic low back pain.There is still no standard method for imaging and analyzing the thoracolumbar fascia.The aim of this study is to advance the understanding of the role of the thoracolumbar fascia in chronic low back pain as well as to advance the analysis methods.

Official Title
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Evaluation of Morphological Features of Thoracolumbar Fascia by Ultrasonography in Patients With Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Ultrasonographic measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Patients with low back pain for more than 6 months Healthy volunteers Exclusion Criteria: Previous low back or back surgery Uncontrolled Diabetes Mellitus Mental retardation Metabolic disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients diagnosed with low back pain<br>Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography. | Device: Ultrasonographic measurements<br>* Posterior layers of the thoracolumbar fascia ,middle layers of the thoracolumbar fascia thickness and Lumbar interfacial triangle thickness CSA (cross-sectional area) measurements of erector spinae muscles, quadratus lumborum muscles and the latissimus dorsi muscles<br>|
| Active Comparator: Healthy volunteers<br>Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography. | Device: Ultrasonographic measurements<br>* Posterior layers of the thoracolumbar fascia ,middle layers of the thoracolumbar fascia thickness and Lumbar interfacial triangle thickness CSA (cross-sectional area) measurements of erector spinae muscles, quadratus lumborum muscles and the latissimus dorsi muscles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fascia thickness | The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSA | CSA (Sectional Area) measurements of erector spina ,quadratus lumborum and latissimus dorsi muscles by ultrasonography | 20 minute | 
| VAS | visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable | 20 minutes | 
| ODİ | Oswestry Disability Index Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.(1) | 30 minutes |