ClinicalTrials.Veeva

Menu

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

H

Hacettepe University

Status

Not yet enrolling

Conditions

Idiopathic Scoliosis
Pain

Study type

Observational

Funder types

Other

Identifiers

NCT06055140
GO 23/516

Details and patient eligibility

About

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

Full description

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.

Enrollment

57 estimated patients

Sex

All

Ages

10+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (with Scoliosis):

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

Inclusion Criteria (for Healthy Individuals):

  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

Trial design

57 participants in 3 patient groups

Idiopathic scoliosis without pain
Description:
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
Description:
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
Description:
In this group, there will be healthy individuals whose pain level, as assessed by the Visual Analog Scale, is below 3.

Trial contacts and locations

1

Loading...

Central trial contact

Sibel Yerli, MSc; Satuk Bugrahan Yinanc, MSc

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems