Clinical trial NCT06978374: Ultrasonographic Assessment of Thoracolumbar Fascia in AxSpA and Controls With Trigger Point Evaluation
Official title: Ultrasonographic Evaluation of Thoracolumbar Fascia Morphology in Axial Spondyloarthropathy and Controls: A Pilot Study With Clinical Assessment of Myofascial Trigger Points
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondylarthritis (axSpA)
Myofascial Trigger Point Pain (MTrP)
Ultrasound Exams
Keywords: Thoracolumbar fascia
Axial Spondyloarthropatis (axSpA)
Myofascial Trigger Point Pain (MTrP)
Ultrasound
Sonography
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasonographic Assessment of Thoracolumbar Fascia (TLF) Thickness
timeFrame: Baseline (Day 1)
measure: Thoracolumbar fascia morphology
timeFrame: Baseline (Day 1)
measure: Presence of myofascial trigger points
timeFrame: Baseline (Day 1)
Secondary outcomes:
measure: Correlation between thoracolumbar fascia thickness and presence of myofascial trigger points
timeFrame: Baseline (Day 1)
measure: Correlation between thoracolumbar fascia morphology and presence of myofascial trigger points
timeFrame: Baseline (Day 1)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Faculty of Medicine Hospital
state: Mamak
Study officials:
affiliation: Ankara University School of Medicine, Department of Rheumathology
name: Sebnem ATAMAN, Study Chair
role: STUDY_CHAIR
affiliation: Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation
name: Yuzlem Gyuner SIDZHIMLI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University School of Medicine, Department of Physical Medicine and Rehabilitation
name: Seçilay GÜNEŞ, Ass Prof
role: STUDY_DIRECTOR
References:
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