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

March 15, 2024 updated by: ilker şengül, Izmir Katip Celebi University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35360
        • İlker Şengül

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subacute stroke patients with painful and stiff shoulder in the hemiplegic side, and healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Painful and stiff hemiplegic side shoulders of stroke patients
Diagnostic test: Imaging
Ultrasonographic imaging of the shoulder
Group B
Asymptomatic non-hemiplegic side shoulders of stroke patients
Diagnostic test: Imaging
Ultrasonographic imaging of the shoulder
Group C
Non-dominant side shoulders of healthy volunteers
Diagnostic test: Imaging
Ultrasonographic imaging of the shoulder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coracohumeral ligament thickness
Time Frame: 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
Through study completion, an average of 3 year
Soft tissue composition of the rotator interval
Time Frame: 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
Through study completion, an average of 3 year
Vascularity in the rotator interval
Time Frame: 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
Through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Principal Investigator: İlker Şengül, M.D., İzmir Katip Çelebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

October 6, 2023

Study Completion (Actual)

October 6, 2023

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-GOKAE-0356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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