Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05366972
• Other study ID #: 2020/06-24
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: May 2022
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Korgün Ökmen, Assoc. PhD.
• Phone: +905057081021
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 15, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Ultrasonographic measurements
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

Locations

Country	Name	City	State
Turkey	Bursa Yuksek Ihtisas Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fascia thickness	The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography.	20 minutes
Secondary	CSA	CSA (Sectional Area) measurements of erector spina ,quadratus lumborum and latissimus dorsi muscles by ultrasonography	20 minute
Secondary	VAS	visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable	20 minutes
Secondary	ODI	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