- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426965
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
The Relationship Between Shoulder Ultrasound Findings and Pain Levels in Acute/Subacute Stroke Patients: A Cross-Sectional Study
Study Overview
Status
Conditions
Detailed Description
Hemiplegic shoulder pain is a common complication after stroke and may negatively affect rehabilitation outcomes. Structural abnormalities such as rotator cuff pathology, biceps tendon disorders, bursitis, adhesive capsulitis, and glenohumeral subluxation can be evaluated using musculoskeletal ultrasound.
This prospective cross-sectional observational study aims to investigate the relationship between shoulder ultrasound abnormality score and pain severity in patients with post-stroke hemiplegic shoulder pain. Adult stroke patients with hemiplegic shoulder pain will be evaluated at admission.
Pain severity will be assessed using the Visual Analog Scale (VAS) separately for rest, movement, and night pain. Shoulder ultrasound will be performed using a standardized protocol, and a total ultrasound abnormality score will be calculated.
The primary objective is to evaluate the association between ultrasound abnormality score and pain severity. Secondary analyses will assess the relationship between specific ultrasound findings and pain severity.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Recruiting
- Ankara Etlik Şehir Hastanesi
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Contact:
- ayşe naz kalem, md
- Phone Number: +905333626947
- Email: kalemnaz@gmail.com
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Contact:
- aliye aygün, md
- Phone Number: +905454764771
- Email: aliyeaygunn@hotmail.com
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Principal Investigator:
- nihal tezel, Associate Professor
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Sub-Investigator:
- aliye aygün, MD,Resident Physician
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Sub-Investigator:
- ayşe naz kalem, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between 18-75 years of age
- Patients with a history of stroke within the last 2 weeks to 6 months
- Patients with shoulder pain on the hemiplegic side
- Mini-mental status test score >25
Exclusion Criteria:
- Motor aphasic patient group
- Patients with a history of previous surgery on the hemiplegic shoulder for any reason
- Those with other diseases that can explain the shoulder pain
- Those with neurodegenerative diseases that cause impairment in cognitive functions, such as dementia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Post-stroke Hemiplegic Shoulder Pain Patients
Adult stroke patients with hemiplegic shoulder pain who are evaluated at admission.
Pain severity is assessed using the Visual Analog Scale (VAS) for rest, movement, and night pain.
Shoulder ultrasound is performed using a standardized protocol, and an ultrasound abnormality score is calculated to evaluate the relationship between structural abnormalities and pain severity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Association between shoulder ultrasound abnormality score and pain severity
Time Frame: At admission (single assessment on the same day as ultrasound)
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Relationship between total shoulder ultrasound abnormality score and Visual Analog Scale (VAS) pain scores (rest, movement, and night pain) assessed at admission.
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At admission (single assessment on the same day as ultrasound)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Pong YP, Wang LY, Huang YC, Leong CP, Liaw MY, Chen HY. Sonography and physical findings in stroke patients with hemiplegic shoulders: a longitudinal study. J Rehabil Med. 2012 Jun;44(7):553-7. doi: 10.2340/16501977-0987.
- Huang SW, Liu SY, Tang HW, Wei TS, Wang WT, Yang CP. Relationship between severity of shoulder subluxation and soft-tissue injury in hemiplegic stroke patients. J Rehabil Med. 2012 Sep;44(9):733-9. doi: 10.2340/16501977-1026.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AEŞH-BADEK1-2025-682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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