Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain
Evaluation of Morphological Features of Thoracolumbar Fascia by Ultrasonography in Patients With Low Back Pain
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started May 2022
Shorter than P25 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedMay 12, 2022
May 1, 2022
2 months
May 5, 2022
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
fascia thickness
The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography.
20 minutes
Secondary Outcomes (3)
CSA
20 minute
VAS
20 minutes
ODİ
30 minutes
Study Arms (2)
Patients diagnosed with low back pain
ACTIVE COMPARATORMeasurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.
Healthy volunteers
ACTIVE COMPARATORMeasurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.
Interventions
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
Eligibility Criteria
You may qualify if:
- years old
- Patients with low back pain for more than 6 months
- Healthy volunteers
You may not qualify if:
- Previous low back or back surgery
- Uncontrolled Diabetes Mellitus
- Mental retardation
- Metabolic disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110, Turkey (Türkiye)
Related Publications (1)
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
PMID: 11074683RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Burcu Metin Ökmen, Assoc. PhD.
Bursa Yuksek Ihtisas Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Phd.M.D
Study Record Dates
First Submitted
May 5, 2022
First Posted
May 10, 2022
Study Start
May 10, 2022
Primary Completion
July 1, 2022
Study Completion
July 15, 2022
Last Updated
May 12, 2022
Record last verified: 2022-05