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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ultrasonographic Assessment of Thoracolumbar Fascia (TLF) Thickness