Clinical trial NCT04613648: Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Terms of Adhesive Capsulitis
Official title: Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Subacute Stroke Patients in Terms of Adhesive Capsulitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adhesive Capsulitis of the Shoulder
Hemiplegia
Keywords: Shoulder
Hemiplegia
Adhesive capsulitis
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subacute stroke patients with painful and stiff shoulder in the hemiplegic side, and healthy volunteers

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Coracohumeral ligament thickness
timeFrame: Through study completion, an average of 3 year
measure: Soft tissue composition of the rotator interval
timeFrame: Through study completion, an average of 3 year
measure: Vascularity in the rotator interval
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İlker Şengül
Study officials:
affiliation: İzmir Katip Çelebi University
name: İlker Şengül, M.D.
role: PRINCIPAL_INVESTIGATOR
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