跳至主要内容
临床试验/NCT04613648
NCT04613648终止不适用

Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Subacute Stroke Patients in Terms of Adhesive Capsulitis

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
16
试验地点
1
主要终点
Vascularity in the rotator interval

研究概览

简要总结

Although a relationship has been reported between stroke and adhesive capsulitis, it is controversial whether the underlying cause of the capsular changes seen in hemiplegic shoulder pain is true adhesive capsulitis. Although there has been a limited number of studies, ultrasound, which has been reported as a sensitive and specific method in the diagnosis of true (idiopathic) adhesive capsulitis, has not yielded similar results to arthrography and MRI in demonstrating fibrotic and adhesive changes in the glenohumeral capsule in stroke patients with hemiplegic shoulder pain. This study aims to investigate ultrasonographic structural changes that may be associated with adhesive capsulitis in subacute stroke patients with painful and stiff hemiplegic side shoulder.

详细描述

Hemiplegic shoulder pain is one of the commonly seen complications of a stroke. Limitation of shoulder joint movement is added to hemiplegic shoulder pain in time. Therefore, adhesive capsulitis is one of the differential diagnoses that come to mind first in patients with hemiplegic shoulder pain and stiffness. Indeed, in arthrographic and magnetic resonance imaging (MRI) studies, it has been reported that adhesive capsulitis (or more accurately, capsular changes), is quite frequent.

Although a relationship has been reported between stroke and adhesive capsulitis, it is controversial whether the underlying cause of the capsular changes seen in hemiplegic shoulder pain is true adhesive capsulitis. Although these capsular changes and joint limitations in patients with hemiplegic shoulder pain may theoretically be related to idiopathic adhesive capsulitis, secondary causes including spasticity, contracture, fibrosis due to lack of movement, rotator cuff lesions, and glenohumeral subluxation have also been emphasized as a cause of the capsular restriction. Although there have been a limited number of studies, ultrasound, which has been reported as a sensitive and specific method in the diagnosis of true (idiopathic) adhesive capsulitis, has not yielded similar results to arthrography and MRI in demonstrating fibrotic and adhesive changes in the glenohumeral capsule in stroke patients with hemiplegic shoulder pain and stiffness. Because ultrasonographic examinations are mostly focused on rotator cuff tendons, bicipital tendon, and subacromial bursa, lack of detailed examination in terms of adhesive capsulitis may be one of the underlying reasons for this inconsistency. In this context, this study aims to investigate ultrasonographic structural changes that may be associated with adhesive capsulitis in subacute stroke patients with painful and stiff hemiplegic side shoulder.

研究设计

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

入排标准

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

入选标准

  • First stroke
  • Stroke duration from 1 month to 6 months
  • To be able to communicate well
  • Presence of hemiplegic side shoulder pain
  • Limitation of passive glenohumeral joint abduction on the hemiplegic side
  • Limitation of passive glenohumeral joint external rotation of the hemiplegic side

排除标准

  • Stroke duration <1 month or > 6 months
  • Only presence of one of the pain or stiffness in the hemiplegic side shoulder
  • History of pre-stroke shoulder pain independent from the side of shoulder
  • Pain and / or stiffness in the non-hemiplegic side shoulder
  • History of shoulder injury (independent from the side)
  • History of upper extremity surgery (independent from the side)
  • Weakness in both upper extremities
  • Existence of non-stroke diseases (osteoarthritis, inflammatory arthritis, etc.) that may cause restriction in the shoulder joint
  • Inability to communicate properly
  • <40 years old
  • Hand pain and/or swelling in addition to shoulder pain and stiffness,

结局指标

主要结局

Vascularity in the rotator interval

时间窗: Through study completion, an average of 3 year

The presence of increased vascularity in the color Doppler sonographic imaging of the rotator interval on the transverse oblique plane

Coracohumeral ligament thickness

时间窗: Through study completion, an average of 3 year

The thickness in mm of the thickest part of the coracohumeral ligament on the axial-oblique plane with the shoulder in the neutral position

Soft tissue composition of the rotator interval

时间窗: Through study completion, an average of 3 year

The presence of soft tissue increase (hypoechogenic compared to the biceps tendon and hyperechogenic compared to the joint fluid around the biceps tendon) in the imaging of the rotator interval on the transverse oblique plane

次要结局

未报告次要终点

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ilker şengül

Principal Investigator

Izmir Katip Celebi University

研究点 (1)

Loading locations...

相似试验