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

Hemiplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04613648
• Other study ID #: 2020-GOKAE-0356
• Status: Terminated
• Start date: October 7, 2020
• Est. completion date: October 6, 2023

Study information

• Verified date: March 2024
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Adhesive Capsulitis of the Shoulder
• Bursitis
• Hemiplegia

Intervention

Diagnostic Test:
• Imaging
Ultrasonographic imaging of the shoulder

Locations

Country	Name	City	State
Turkey	Ilker Sengül	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

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Wu H, Tian H, Dong F, Liang W, Song D, Zeng J, Ding Z, Shi Y, Luo H, Xu J. The role of grey-scale ultrasound in the diagnosis of adhesive capsulitis of the shoulder: a systematic review and meta-analysis. Med Ultrason. 2020 Sep 5;22(3):305-312. doi: 10.11152/mu-2430. Epub 2020 Apr 14. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coracohumeral ligament thickness	The thickness in mm of the thickest part of the coracohumeral ligament on the axial-oblique plane with the shoulder in the neutral position	Through study completion, an average of 3 year
Primary	Soft tissue composition of the rotator interval	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	Through study completion, an average of 3 year
Primary	Vascularity in the rotator interval	The presence of increased vascularity in the color Doppler sonographic imaging of the rotator interval on the transverse oblique plane	Through study completion, an average of 3 year