Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05366972
Collaborator
(none)
70
1
2
2.2
32.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasonographic measurements
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Morphological Features of Thoracolumbar Fascia by Ultrasonography in Patients With Low Back Pain
Anticipated Study Start Date :
May 10, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patients diagnosed with low back pain

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

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

Active Comparator: Healthy volunteers

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

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

Outcome Measures

Primary Outcome Measures

  1. fascia thickness [20 minutes]

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

Secondary Outcome Measures

  1. CSA [20 minute]

    CSA (Sectional Area) measurements of erector spina ,quadratus lumborum and latissimus dorsi muscles by ultrasonography

  2. VAS [20 minutes]

    visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Yuksek Ihtisas Training and Research Hospital Bursa Turkey 16110

Sponsors and Collaborators

  • Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Study Chair: Burcu Metin Ökmen, Assoc. PhD., Bursa Yuksek Ihtisas Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Korgün Ökmen, Assoc.Phd.M.D, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05366972
Other Study ID Numbers:
  • 2020/06-24
First Posted:
May 10, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2022