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

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04613648
Collaborator
(none)
60
1
35.9
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Subacute Stroke Patients in Terms of Adhesive Capsulitis
Actual Study Start Date :
Oct 7, 2020
Anticipated Primary Completion Date :
Oct 6, 2023
Anticipated Study Completion Date :
Oct 6, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 İlker Şengül İzmir Turkey 35360

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ilker şengül, Principal Investigator, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT04613648
Other Study ID Numbers:
  • 2020-GOKAE-0356
First Posted:
Nov 3, 2020
Last Update Posted:
Dec 9, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ilker şengül, Principal Investigator, Izmir Katip Celebi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2021