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

Terminated

• Conditions: Hemiplegia; Adhesive Capsulitis of the Shoulder
• Interventions: Diagnostic Test: Imaging

• Registration Number: NCT04613648
• Lead Sponsor: Izmir Katip Celebi University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-07
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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

Exclusion Criteria

• 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,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Imaging	Painful and stiff hemiplegic side shoulders of stroke patients
Group B	Imaging	Asymptomatic non-hemiplegic side shoulders of stroke patients
Group C	Imaging	Non-dominant side shoulders of healthy volunteers

Primary Outcome Measures

Name	Time	Method
Vascularity in the rotator interval	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	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	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

Trial Locations

Locations (1)

İlker Şengül; 🇹🇷 İzmir, Turkey