Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis

NCT ID: NCT06055140

Last Updated: 2023-09-26

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

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-31

Brief Summary

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This observational study seeks to explore the potential association between thoracolumbar fascia characteristics and low back pain in individuals diagnosed with idiopathic scoliosis.

Detailed Description

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This observational study aims to investigate the potential link between thoracolumbar fascia characteristics and low back pain in individuals with idiopathic scoliosis. The hypothesis underlying this study posits that alterations in thoracolumbar fascia thickness and properties contribute to changes in trunk flexibility and subsequently influence the occurrence and intensity of low back pain in patients with idiopathic scoliosis. The researchers believe that an increase in thoracolumbar fascia thickness may lead to reduced trunk flexibility, restricting the normal range of motion and potentially causing or exacerbating low back pain.

To explore this hypothesis, the study will include participants diagnosed with idiopathic scoliosis. The researchers will measure thoracolumbar fascia thickness using ultrasound and assess trunk flexibility through various range of motion tests, including trunk flexion, extension, and lateral flexion using a goniometer, as well as the sit-and-reach test. To quantify the severity of the spinal curvature, the Cobb angle will be measured on anteroposterior standing radiographs.

Participants will also be asked to report their pain levels using the Visual Analog Scale, a simple tool where individuals rate their pain on a scale from 0 to 10. By analyzing the collected data, the researchers aim to establish potential correlations between thoracolumbar fascia thickness, trunk flexibility, and low back pain in individuals with idiopathic scoliosis.

Conditions

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Idiopathic Scoliosis Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Idiopathic scoliosis without pain

In this group, there will be individuals diagnosed with idiopathic scoliosis whose Cobb angle is above 15 degrees and whose pain level, as assessed by the Visual Analog Scale, is below 3.

No interventions assigned to this group

Idiopathic scoliosis with pain

In this group, there will be individuals diagnosed with idiopathic scoliosis whose Cobb angle is above 15 degrees, and their pain level, as assessed by the Visual Analog Scale, is above 3.

No interventions assigned to this group

Control

In this group, there will be healthy individuals whose pain level, as assessed by the Visual Analog Scale, is below 3.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Being 10 years of age or older
2. Having a diagnosis of idiopathic scoliosis
3. Having a Cobb angle measurement above 15 degrees


1. Being 10 years of age or older
2. Have no pathological spinal curvature.
3. Have no history of low back pain in the last 3 months (Visual Analog Scale score \<3/10).

Exclusion Criteria

1. Having any neurological, psychological, congenital, or rheumatological condition
2. Having a history of surgery or trauma involving the lower extremities or spinal region within the last 1 year
3. Having received any previous treatment related to scoliosis
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Gözde Yagci (Gür)

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sibel Yerli, MSc, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Satuk Bugrahan Yinanc, MSc, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Gözde Yağcı, PhD, PT

Role: STUDY_DIRECTOR

Hacettepe University

Fatih Erbahçeci, PhD, PT

Role: STUDY_DIRECTOR

Hacettepe University

Levent Özçakar, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University, Institute of Health Sciences, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Sibel Yerli, MSc

Role: CONTACT

+905374243742

Satuk Bugrahan Yinanc, MSc

Role: CONTACT

+905453957815

References

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Choudhry MN, Ahmad Z, Verma R. Adolescent Idiopathic Scoliosis. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. eCollection 2016.

Reference Type BACKGROUND
PMID: 27347243 (View on PubMed)

Pirri C, Pirri N, Guidolin D, Macchi V, Porzionato A, De Caro R, Stecco C. Ultrasound Imaging of Thoracolumbar Fascia Thickness: Chronic Non-Specific Lower Back Pain versus Healthy Subjects; A Sign of a "Frozen Back"? Diagnostics (Basel). 2023 Apr 16;13(8):1436. doi: 10.3390/diagnostics13081436.

Reference Type BACKGROUND
PMID: 37189537 (View on PubMed)

Other Identifiers

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GO 23/516

Identifier Type: -

Identifier Source: org_study_id

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