NCT06978374

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

Ultrasonographic Evaluation of Thoracolumbar Fascia Morphology in Axial Spondyloarthropathy and Controls: A Pilot Study With Clinical Assessment of Myofascial Trigger Points

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Sonographic examination of thoracolumbar fascia, manual examination of MTrP	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).

Timeline

• Start date: 2020-11-01
• Primary completion: 2024-12-01
• Completion: 2025-03-30
• First posted: 2025-05-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: Turkey (Türkiye)