Ultrasonographic Assessment of Thoracolumbar Fascia in AxSpA and Controls With Trigger Point Evaluation

NCT06978374 | Completed

• 1 other identifier: AUPMRYGSThesis
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate whether changes in the thoracolumbar fascia (TLF)-a connective tissue in the lower back-are related to pain and disease severity in patients with axial spondyloarthropathy (ax-SpA), a chronic inflammatory spine condition. The study involves adults diagnosed with ax-SpA and healthy volunteers of similar age and gender. The main questions it aims to answer are: Is the thickness or shape of the thoracolumbar fascia different in patients with ax-SpA compared to healthy individuals? Is there a relationship between changes in the thoracolumbar fascia and the presence of painful muscle trigger points? Researchers will compare measurements in ax-SpA patients and healthy volunteers to see if differences in fascia structure are linked to pain, function, and disease activity. Participants will: Undergo a back ultrasound (non-invasive imaging) to assess the thickness and structure of the thoracolumbar fascia. Be examined for muscle trigger points using gentle manual palpation. Complete questionnaires and assessments on physical function, quality of life, and disease activity.

Conditions

Axial Spondylarthritis (axSpA); Myofascial Trigger Point Pain (MTrP); Ultrasound Exams

Keywords

Thoracolumbar fascia; Axial Spondyloarthropatis (axSpA); Myofascial Trigger Point Pain (MTrP); Ultrasound; Sonography

Outcome Measures

Primary Outcomes (3)

• Ultrasonographic Assessment of Thoracolumbar Fascia (TLF) Thickness

  Thickness of the thoracolumbar fascia (TLF) will be measured using musculoskeletal ultrasound at the L2-L3 vertebral level, bilaterally. Unit of measures: millimeters (mm)

  Baseline (Day 1)

• Thoracolumbar fascia morphology

  The morphology of the thoracolumbar fascia will be evaluated bilaterally as either regular or irregular based on ultrasonographic appearance at the same level. Unit of Measure: Categorical (Regular/Irregular)

  Baseline (Day 1)

• Presence of myofascial trigger points

  Presence or absence of myofascial trigger points will be assessed through standardized manual palpation criteria during clinical examination. Unit of Measure: Binary (Present/Absent)

  Baseline (Day 1)

Secondary Outcomes (2)

• Correlation between thoracolumbar fascia thickness and presence of myofascial trigger points

  Baseline (Day 1)

• Correlation between thoracolumbar fascia morphology and presence of myofascial trigger points

  Baseline (Day 1)

Study Arms (2)

AxSpA group

This study included individuals aged between 18 and 65 years who were classified as having axial spondyloarthritis (axSpA), including both radiographic and non-radiographic forms, according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria. Participants with additional health conditions that could affect thoracolumbar fascia (TLF) morphology or spinal biomechanics were excluded from the study. Exclusion criteria included: History of severe back or lower extremity trauma or surgery, Significant spinal deformity (e.g., scoliosis, kyphosis, spinal stenosis), History of spinal surgery, History of spinal fracture, Malignancy or spinal infection, Neurological deficit due to nerve root compression, Neurological or major psychiatric disorders, Bleeding disorders, Previous lumbar steroid injection or current systemic steroid use, Pregnancy, Disability status or ongoing legal process related to low back pain, Presence of acute systemic infection

Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrP

Healthy group

Participants in the healthy control group were age-matched (18-65 years) and selected according to the same exclusion criteria applied to the patient group.

Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrP

Interventions

Sonographic examination of thoracolumbar fascia, manual examination of MTrP OTHER

Patients were positioned in the prone position, with a cushion placed under the abdomen to flatten the lumbar lordosis. A 14-18 MHz linear transducer was used for ultrasonographic (USG) evaluation, performed with a GE Logiq P5 ultrasound device (Serial No: GE-114118SU3). The USG probe was placed longitudinally at the L2-L3 intervertebral level, 2 cm lateral to the vertical line connecting the spinous processes on both sides, in order to assess the thoracolumbar fascia (TLF).

AxSpA group; Healthy group

Eligibility Criteria

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

Study Population

Adult male and female participants aged 18 to 65 years, who presented to the Rheumatology outpatient clinics of Ankara University School of Medicine Hospital, including individuals diagnosed with axial spondyloarthritis based on ASAS criteria and healthy controls who provided written informed consent.

You may qualify if:

• Individuals aged between 18 and 65 years
• Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of -SpondyloArthritis International Society (ASAS) classification criteria, or being a healthy control with no known musculoskeletal or systemic inflammatory disease
• Ability to lie in the prone position for ultrasonographic examination
• Willingness to participate in the study

You may not qualify if:

• History of significant back or lower extremity trauma or orthopedic surgery
• Presence of major spinal deformities (e.g., scoliosis, kyphosis, spinal stenosis)
• History of spinal surgery or spinal fracture
• Known malignancy or spinal infection
• Neurological deficits due to nerve root compression
• Presence of a diagnosed neurological or major psychiatric disorder
• Known bleeding disorders
• History of lumbar steroid injection or current use of systemic corticosteroids
• Current pregnancy
• Legal or disability status related to low back pain
• Presence of an acute systemic infection
• Refusal or inability to provide written informed consent

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University, Faculty of Medicine Hospital

Ankara, Mamak, 06100, Turkey (Türkiye)

Location

Related Publications (5)

• De Coninck K, Hambly K, Dickinson JW, Passfield L. Measuring the morphological characteristics of thoracolumbar fascia in ultrasound images: an inter-rater reliability study. BMC Musculoskelet Disord. 2018 Jun 1;19(1):180. doi: 10.1186/s12891-018-2088-5.

  PMID: 29859080 BACKGROUND

• Abe H, Hayashi S, Kim JH, Murakami G, Rodriguez-Vazquez JF, Jin ZW. Fetal development of the thoracolumbar fascia with special reference to the fascial connection with the transversus abdominis, latissimus dorsi, and serratus posterior inferior muscles. Surg Radiol Anat. 2021 Jun;43(6):917-928. doi: 10.1007/s00276-020-02668-4. Epub 2021 Jan 12.

  PMID: 33438110 BACKGROUND

• Boccon Gibod L, Correas G, Godefroy D, Ducellier R, Teyssier P. [Radio-transparent renal calculi and epithelial tumours. Contribution of ultrasound and CT scan to the diagnosis (author's transl)]. Nouv Presse Med. 1981 Oct 31;10(39):3231-2. French.

  PMID: 7301552 BACKGROUND

• Kondrup F, Gaudreault N, Venne G. The deep fascia and its role in chronic pain and pathological conditions: A review. Clin Anat. 2022 Jul;35(5):649-659. doi: 10.1002/ca.23882. Epub 2022 Apr 27.

  PMID: 35417568 BACKGROUND

• Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.

  PMID: 31151377 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Sebnem ATAMAN, Study Chair

  Ankara University School of Medicine, Department of Rheumathology

  STUDY CHAIR

• Yuzlem Gyuner SIDZHIMLI, MD

  Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Seçilay GÜNEŞ, Ass Prof

  Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 18, 2025
• Study Start: November 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: March 30, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)