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

A

Ankara University

Status

Completed

Conditions

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

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06978374
AUPMRYGSThesis

Details and patient eligibility

About

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.

Full description

The goal of this observational study is to explore whether structural changes in the thoracolumbar fascia (TLF)-a connective tissue layer in the lower back-are related to pain, stiffness, and disease activity in individuals with axial spondyloarthropathy (ax-SpA), a chronic inflammatory condition that affects the spine and can cause significant back pain and limited mobility. The study also examines whether these changes are linked to myofascial trigger points, which are sensitive or painful spots in the muscles.

This research includes adults diagnosed with ax-SpA, as well as healthy volunteers of similar age and gender who do not have chronic back pain or spinal diseases.

The main questions it aims to answer are:

Do patients with ax-SpA have increased thickness or irregular structure in the thoracolumbar fascia compared to healthy individuals? Is there a connection between fascia changes and the presence of painful muscle trigger points? Are these findings related to the severity of disease symptoms, such as pain, stiffness, physical function, and quality of life? Does the use of anti-inflammatory or immune-modulating medications affect the presence of these muscle trigger points? Researchers will compare ultrasound and clinical findings between ax-SpA patients and healthy volunteers to determine whether structural differences in the fascia can be used as a non-invasive indicator of disease burden.

Participants will:

Undergo a high-resolution ultrasound scan of their lower back to assess the structure and thickness of the thoracolumbar fascia.

Receive a manual examination to check for muscle trigger points in the lower back.

Complete questionnaires related to pain, function, fatigue, and quality of life.

Share information about their medical history, including the use of medications such as non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), and TNF-alpha inhibitors.

Enrollment

132 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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
  • Provision of written informed consent prior to inclusion

Exclusion criteria

  • 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

Trial design

132 participants in 2 patient groups

AxSpA group
Description:
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
Treatment:
Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrP
Healthy group
Description:
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.
Treatment:
Other: Sonographic examination of thoracolumbar fascia, manual examination of MTrP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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