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Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasonographic measurements
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bursa Yuksek Ihtisas Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients diagnosed with low back pain

Healthy volunteers

Arm Description

Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.

Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.

Outcomes

Primary Outcome Measures

fascia thickness
The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography.

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2022
Last Updated
May 9, 2022
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05366972
Brief Title
Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain
Official Title
Evaluation of Morphological Features of Thoracolumbar Fascia by Ultrasonography in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 10, 2022 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients diagnosed with low back pain
Arm Type
Active Comparator
Arm Description
Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Measurements of the back muscles and thoracolumbar fascia will be made by ultrasonography.
Intervention Type
Device
Intervention Name(s)
Ultrasonographic measurements
Intervention Description
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
Primary Outcome Measure Information:
Title
fascia thickness
Description
The posterior, middle layer thoracolumbar fascia thickness and Lumbar interface triangle thickness were determined by ultrasonography.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
CSA
Description
CSA (Sectional Area) measurements of erector spina ,quadratus lumborum and latissimus dorsi muscles by ultrasonography
Time Frame
20 minute
Title
VAS
Description
visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable
Time Frame
20 minutes
Title
ODİ
Description
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)
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Korgün Ökmen, Assoc. PhD.
Phone
+905057081021
Email
korgunokmen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Metin Ökmen, Assoc. PhD.
Organizational Affiliation
Bursa Yuksek Ihtisas Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bursa Yuksek Ihtisas Training and Research Hospital
City
Bursa
ZIP/Postal Code
16110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
11074683
Citation
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.
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Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

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