Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

NCT ID: NCT05366972

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2022-07-15

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Patients diagnosed with low back pain

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

Group Type ACTIVE_COMPARATOR

Ultrasonographic measurements

Intervention Type DEVICE

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

Healthy volunteers

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

Group Type ACTIVE_COMPARATOR

Ultrasonographic measurements

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Korgün Ökmen

Assoc.Phd.M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu Metin Ökmen, Assoc. PhD.

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

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Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Korgün Ökmen, Assoc. PhD.

Role: CONTACT

+905057081021

References

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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.

Reference Type RESULT
PMID: 11074683 (View on PubMed)

Other Identifiers

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2020/06-24

Identifier Type: -

Identifier Source: org_study_id

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