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

Sponsor
Hacettepe University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06055140
Collaborator
(none)
57
1
3
18.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    57 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Thoracolumbar Fascia Thickness [Baseline]

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

    Secondary Outcome Measures

    1. Visual analog scale [Baseline]

      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.

    2. Trunk Normal Range of Motion [Baseline]

      The degrees of trunk flexion, extension, right lateral flexion, and left lateral flexion obtained after goniometric measurements.

    3. Trunk Flexibility [Baseline]

      The sit-and-reach test and trunk rotation values will be recorded in centimeters.

    4. McGill Short Form Pain Questionnaire [Baseline]

      A questionnaire providing numerical outputs about the sensory qualities, affective qualities, and intensity of pain.

    5. Oswestry Low Back Pain Disability Questionnaire [Baseline]

      A questionnaire scored from 0 to 50, assessing the impact of low back pain on daily life activities.

    6. Scoliosis Research Society-30 (SRS-30) [Baseline]

      This questionnaire consists of 30 questions and is used to evaluate the health-related quality of life in individuals with scoliosis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University, Institute of Health Sciences, Faculty of Physical Therapy and Rehabilitation Ankara Altındağ Turkey 06100

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    • Principal Investigator: Sibel Yerli, MSc, PT, Hacettepe University
    • Principal Investigator: Satuk Bugrahan Yinanc, MSc, PT, Hacettepe University
    • Study Director: Gözde Yağcı, PhD, PT, Hacettepe University
    • Study Director: Fatih Erbahçeci, PhD, PT, Hacettepe University
    • Principal Investigator: Levent Özçakar, Phd, MD, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gözde Yagci (Gür), Associate Professor, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT06055140
    Other Study ID Numbers:
    • GO 23/516
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gözde Yagci (Gür), Associate Professor, Hacettepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 26, 2023