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临床试验/NCT06727266
NCT06727266已完成不适用

Ultrasonographic Evaluation of the Shoulder Joint in Patients With Axial Spondyloarthritis

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Shoulder ultrasound findings

研究概览

简要总结

The aim of this observational study is to assess shoulder joint involvement in patients with axial spondyloarthritis using ultrasound and to compare the findings with those of healthy controls.

详细描述

Axial spondyloarthritis (axial SpA) is a chronic inflammatory rheumatic disease that causes inflammation of the spine and sacroiliac joints. The condition usually begins at a young age (between 20 and 40 years). Common complaints include back pain, morning stiffness, and gradual restriction of spinal movement. Complaints of peripheral joint involvement may also be observed.

Shoulder involvement in patients with axial spondyloarthritis (axial SpA) represents a manifestation of the disease that can affect peripheral joints. Shoulder involvement typically develops as a result of an inflammatory process and is manifested by symptoms such as pain, swelling, and limitation of movement. The glenohumeral joint, acromioclavicular joint, subacromial bursa, and rotator cuff tendons are most commonly affected. Such peripheral joint involvement may indicate a more severe progression of axial SpA and an increased future disease burden.

Ultrasound is an inexpensive, non-invasive, and radiation-free imaging modality that is widely used in the assessment of the musculoskeletal system. In inflammatory rheumatic diseases such as axial SpA, ultrasound is a highly effective method for the early detection of inflammation. Inflammatory findings such as synovitis, tenosynovitis, enthesitis, and bursitis can be identified by ultrasound in the early stages of the disease. Early detection of these findings can slow disease progression and prevent joint damage by facilitating timely initiation of treatment.

The objective of this observational study is to evaluate the shoulder joint using ultrasound in patients with axial spondyloarthritis and to compare the findings with healthy controls.

The case group will consist of patients aged 18 to 65 who have been diagnosed with axial spondyloarthritis by a specialist in physical medicine and rehabilitation and who are being followed up at the PMR Outpatient Clinics of the Department of Physical Medicine and Rehabilitation, University of Health Sciences Gaziosmanpaşa Training and Research Hospital.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a radiographic or non-radiographic diagnosis of axial spondyloarthritis according to ASAS 2009 classification criteria
  • Patients aged 18-65
  • For healthy controls; people aged 18-65 years who attended PMR outpatient clinics for any reason, without a diagnosis of inflammatory disease and without complaints of shoulder pain.

排除标准

  • People under 18 and over 65
  • History of shoulder trauma
  • History of upper extremity surgery
  • History of fracture of the upper extremity
  • History of malignancy
  • Pregnancy

结局指标

主要结局

Shoulder ultrasound findings

时间窗: baseline

Pathologies detected in the shoulder joint will be evaluated; tendon damage, bursitis, joint effusion, enthesitis etc. Enthesitis: Abnormal hypoechoic structure (loss of fibrillar structure of the tendon), thickening at the site of attachment of the tendon or ligament to the bone with associated Doppler signal and bone irregularities (calcification, cortical irregularity, enthesophyte). Synovitis: An abnormal hypoechoic intra-articular structure that is less compressed and may give a Doppler signal. Bursitis: Normally the bursa contains a thin layer of fluid, but in bursitis the amount of fluid increases and the bursa enlarges. There may be a marked thickening of the bursa walls. In bursitis, especially if it is chronic, septations (membrane formations) may be seen within the bursa. Effusion: Increased fluid in the joint space, manifested as anechoic fluid. Erosion: Causes irregularity or disruption of the normally flat bone cortex.

次要结局

  • BASDAI(baseline)
  • BASFI(baseline)
  • BASMI(baseline)
  • VAS(baseline)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Berke Demir

doctor

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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