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

NCT06055140 | Unknown DMC

• 1 other identifier: GO 23/516
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Scoliosis; Pain

Keywords

fascia; scoliosis; pain

Outcome Measures

Primary Outcomes (1)

• Thoracolumbar Fascia Thickness

  The thoracolumbar fascia thickness (mm) obtained after ultrasonographic assessment.

  Baseline

Secondary Outcomes (6)

• Visual analog scale

  Baseline

• Trunk Normal Range of Motion

  Baseline

• Trunk Flexibility

  Baseline

• McGill Short Form Pain Questionnaire

  Baseline

• Oswestry Low Back Pain Disability Questionnaire

  Baseline

Study Arms (3)

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.

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.

Control

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

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be selected using snowball sampling from individuals diagnosed with idiopathic scoliosis and aged 10 years or older, who meet the inclusion criteria. Snowball sampling involves initially recruiting participants who meet the inclusion criteria and then asking them to refer other potential participants from their social network who also have idiopathic scoliosis. Exclusion criteria will involve individuals with neurological, psychological, congenital, or rheumatological conditions, those with a history of surgery or trauma involving the lower extremities or spinal region within the last 1 year, and individuals who have received any previous treatment related to scoliosis.

You may qualify if:

• Being 10 years of age or older
• Having a diagnosis of idiopathic scoliosis
• Having a Cobb angle measurement above 15 degrees
• Being 10 years of age or older
• Have no pathological spinal curvature.
• Have no history of low back pain in the last 3 months (Visual Analog Scale score \<3/10).

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

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

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

Related Publications (2)

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

  PMID: 27347243 BACKGROUND

• 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.

  PMID: 37189537 BACKGROUND

MeSH Terms

Conditions

Pain; Scoliosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Sibel Yerli, MSc, PT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Satuk Bugrahan Yinanc, MSc, PT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Gözde Yağcı, PhD, PT

  Hacettepe University

  STUDY DIRECTOR

• Fatih Erbahçeci, PhD, PT

  Hacettepe University

  STUDY DIRECTOR

• Levent Özçakar, Phd, MD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel Yerli, MSc

CONTACT

+905374243742; sibelyerli@hacettepe.edu.tr

Satuk Bugrahan Yinanc, MSc

CONTACT

+905453957815; satukby@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 26, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

TU (1)