Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

Not Applicable

• Conditions: Low Back Pain
• Interventions: Device: Ultrasonographic measurements

• Registration Number: NCT05366972
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-09
• Study Start: 2022-05-10
• Study First Posted: 2022-05-10
• Last Update Posted: 2022-05-12
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with low back pain	Ultrasonographic measurements	Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.
Healthy volunteers	Ultrasonographic measurements	Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.

Primary Outcome Measures

Name	Time	Method
fascia thickness	20 minutes	The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography.

Secondary Outcome Measures

Name	Time	Method
CSA	20 minute	CSA (Sectional Area) measurements of erector spina ,quadratus lumborum and latissimus dorsi muscles by ultrasonography
VAS	20 minutes	visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable
ODİ	30 minutes	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)

Trial Locations

Locations (1)

Bursa Yuksek Ihtisas Training and Research Hospital; 🇹🇷 Bursa, Turkey