Clinical trial NCT06055140: Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis
Official title: Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Idiopathic Scoliosis
Pain
Keywords: fascia
scoliosis
pain
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 57
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Thoracolumbar Fascia Thickness
timeFrame: Baseline
Secondary outcomes:
measure: Visual analog scale
timeFrame: Baseline
measure: Trunk Normal Range of Motion
timeFrame: Baseline
measure: Trunk Flexibility
timeFrame: Baseline
measure: McGill Short Form Pain Questionnaire
timeFrame: Baseline
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: Baseline
measure: Scoliosis Research Society-30 (SRS-30)
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Institute of Health Sciences, Faculty of Physical Therapy and Rehabilitation
state: Altındağ
Study officials:
affiliation: Hacettepe University
name: Sibel Yerli, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Satuk Bugrahan Yinanc, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Gözde Yağcı, PhD, PT
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Fatih Erbahçeci, PhD, PT
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Levent Özçakar, Phd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choudhry MN, Ahmad Z, Verma R. Adolescent Idiopathic Scoliosis. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. eCollection 2016.
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.