跳至主要内容
临床试验/NCT06572696
NCT06572696招募中不适用

Ultrasonographic Evaluation of Asymptomatic Shoulder Joint Pathologies in Rheumatoid Arthritis Patients Compared to Healthy Controls: Case-Controlled Study

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Ultrasound Shoulder Pathology Rating Scale

研究概览

简要总结

Ultrasonographic determination of changes and degree of damage in asymptomatic shoulder joint periarticular structures in RA patients and comparison with healthy controls.

详细描述

It was designed as a prospective single-blind case-controlled clinical study. Written informed consent was obtained from all study participants who met the study criteria and agreed to participate in the study.

30 RA patients between the ages of 18-75 who had been diagnosed with RA for at least 12 months according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and had no complaint of shoulder pain; Patients will be randomly assigned to the patient group according to the order in which they arrive at the outpatient clinic, regardless of age, gender and disease activation. Exclusion criteria for the study include patients with clinically suspected shoulder pathology, a history of previous shoulder surgery, a history of direct trauma to the shoulder, a history of infectious arthritis, other connective tissue diseases, serious and chronic somatic or psychiatric diseases, any previous fracture in the upper extremities, and patients with limited joint movement.

Healthy volunteers who do not have any complaints or problems regarding the shoulder area will be included in the control group, consisting of a total of 30 participants with similar age, gender and non-RA comorbidities as the RA patient group. Exclusion criteria are the same as the exclusion criteria for the RA patient group.

Demographic data of RA and healthy volunteers such as age, height, weight, body mass index (BMI), gender, marital status, education level, occupation and dominant hand will be recorded. Joint examinations will be performed by an experienced rheumatologist to evaluate the patients' sensitive and swollen joints. The medical history of the patients with RA, including the duration of the disease and the medications they use, and the shoulder joint examination of all participants will be performed by the same physical medicine and rehabilitation specialist doctor blinded to the patient and healthy volunteers. During the examination, joint range of motion (ROM) which include active and passive flexion, extension, abduction, internal and external rotation movements of the shoulder and special tests (Hawkins, Neer, Jobe, Patte, Yergason, Gerber) will be used.

US evaluation of both shoulders of all participants will be performed by the same experienced doctor with more than 5 years of experience in this field, using the MyLab60 brand US machine with a 7-12 MHz superficial probe. The physician performing the evaluation will be blinded to the participants. In order to evaluate intra-rater reliability, measurements will be made twice on 5 patients, 1 day apart.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • RA patients between the ages of 18-75 who has been diagnosed with RA for at least 12 months according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and has no complaint of shoulder pain.

排除标准

  • Patients with clinically suspected shoulder pathology, a history of previous shoulder surgery, a history of direct trauma to the shoulder, a history of infectious arthritis, other connective tissue diseases, serious and chronic somatic or psychiatric diseases, any fracture in the upper extremities, and patients with limited joint movement.

结局指标

主要结局

Ultrasound Shoulder Pathology Rating Scale

时间窗: 20 minute

Ultrasound Shoulder Pathology Rating Scale point

次要结局

  • Acromiohumeral Distance(5 minute)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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