Ultrasonographic Assessment of Painful and Stiff Hemiplegic Shoulder in Terms of Adhesive Capsulitis
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| ClinicalTrials.gov Identifier: NCT04613648 |
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Recruitment Status :
Recruiting
First Posted : November 3, 2020
Last Update Posted : December 9, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Adhesive Capsulitis of the Shoulder Hemiplegia | Diagnostic Test: Imaging |
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 |
| Estimated 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 : | October 7, 2020 |
| Estimated Primary Completion Date : | October 6, 2023 |
| Estimated Study Completion Date : | October 6, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Group A
Painful and stiff hemiplegic side shoulders of stroke patients
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Diagnostic Test: Imaging
Ultrasonographic imaging of the shoulder |
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Group B
Asymptomatic non-hemiplegic side shoulders of stroke patients
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Diagnostic Test: Imaging
Ultrasonographic imaging of the shoulder |
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Group C
Non-dominant side shoulders of healthy volunteers
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Diagnostic Test: Imaging
Ultrasonographic imaging of the shoulder |
- 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
- 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
- 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
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613648
| Contact: İlker Şengül, M.D. | 0905337333698 | ilkrsngl@gmail.com | |
| Contact: Ayhan Aşkın, M.D. | 0905327621932 | ayhanaskin@hotmail.com |
| Turkey | |
| İlker Şengül | Recruiting |
| İzmir, Turkey, 35360 | |
| Contact: İlker Şengül, M.D. 05337333698 ilkrsngl@gmail.com | |
| Contact: Ayhan Aşkın, M.D. 05327621932 ayhanaskin@hotmail.com | |
| Principal Investigator: İlker Şengül, M.D. | |
| Sub-Investigator: Ayhan Aşkın, M.D. | |
| Sub-Investigator: Aliye Tosun, M.D. | |
| Sub-Investigator: Özgür Tosun, M.D. | |
| Principal Investigator: | İlker Şengül, M.D. | İzmir Katip Çelebi University |
| Responsible Party: | ilker şengül, Principal Investigator, Izmir Katip Celebi University |
| ClinicalTrials.gov Identifier: | NCT04613648 |
| Other Study ID Numbers: |
2020-GOKAE-0356 |
| First Posted: | November 3, 2020 Key Record Dates |
| Last Update Posted: | December 9, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Shoulder Hemiplegia Adhesive capsulitis |
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Bursitis Hemiplegia Paralysis Neurologic Manifestations |
Nervous System Diseases Joint Diseases Musculoskeletal Diseases |