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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055140
• Other study ID #: GO 23/516
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: January 2024

Study information

• Verified date: September 2023
• Source: Hacettepe University
• Contact: Sibel Yerli, MSc
• Phone: +905374243742
• Email: sibelyerli[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: January 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Idiopathic Scoliosis
• Low Back Pain
• Pain
• Scoliosis

Locations

Country	Name	City	State
Turkey	Hacettepe University, Institute of Health Sciences, Faculty of Physical Therapy and Rehabilitation	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thoracolumbar Fascia Thickness	The thoracolumbar fascia thickness (mm) obtained after ultrasonographic assessment.	Baseline
Secondary	Visual analog scale	The pain levels of individuals obtained after the Visual Analog Scale assessment.Patients will be asked to mark their perceived pain levels on a 100-millimeter horizontal line.	Baseline
Secondary	Trunk Normal Range of Motion	The degrees of trunk flexion, extension, right lateral flexion, and left lateral flexion obtained after goniometric measurements.	Baseline
Secondary	Trunk Flexibility	The sit-and-reach test and trunk rotation values will be recorded in centimeters.	Baseline
Secondary	McGill Short Form Pain Questionnaire	A questionnaire providing numerical outputs about the sensory qualities, affective qualities, and intensity of pain.	Baseline
Secondary	Oswestry Low Back Pain Disability Questionnaire	A questionnaire scored from 0 to 50, assessing the impact of low back pain on daily life activities.	Baseline
Secondary	Scoliosis Research Society-30 (SRS-30)	This questionnaire consists of 30 questions and is used to evaluate the health-related quality of life in individuals with scoliosis.	Baseline