Hemiplegic Shoulder PainNCT07426965
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
An observational study of Hemiplegic Shoulder Pain and Stroke, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hemiplegic shoulder pain is a frequent complication after stroke and may be associated with structural abnormalities detectable by musculoskeletal ultrasound. This prospective cross-sectional observational study aims to evaluate the relationship between shoulder ultrasound abnormality score and pain severity in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegic Shoulder Pain, Stroke
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with stroke and hemiplegic shoulder pain who are admitted to the physical medicine and rehabilitation clinic of Ankara Etlik City Hospital will be included. Eligible patients are between 18 and 75 years of age and within 2 weeks to 6 months after stroke. All participants will undergo clinical assessment and shoulder ultrasound examination at admission.
Who may be able to join
- 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 State Examination (MMSE) score >25
Who cannot join
- Patients with motor aphasia
- Patients with a history of previous surgery on the hemiplegic shoulder for any reason
- Patients with other medical conditions that may independently account for shoulder pain.
- Those with neurodegenerative diseases that cause impairment in cognitive functions, such as dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Ankara, 06010
Ayşe Naz Kalem, MD, +90533 362 69 47, kalemnaz@gmail.com
Aliye Aygün, MD, +90545 476 47 71, aliyeaygunn@hotmail.com
About this study
Official title: The Relationship Between Shoulder Ultrasound Findings and Pain Levels in Acute/Subacute Stroke Patients: A Cross-Sectional Study
Hemiplegic shoulder pain is a frequent complication after stroke and may be associated with structural abnormalities detectable by musculoskeletal ultrasound. This prospective cross-sectional observational study aims to evaluate the relationship between shoulder ultrasound abnormality score and pain severity in patients with post-stroke hemiplegic shoulder pain. Pain severity will be assessed using the Visual Analog Scale (VAS) for rest, exercise, and night pain. Shoulder ultrasound will be performed using a standardized scoring system to quantify structural abnormalities. The primary objective is to investigate whether ultrasound abnormality burden is associated with pain severity in different clinical conditions (rest, exercise, and night).
Read the 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.
- Conditions
- Hemiplegic Shoulder Pain, Stroke
- Keywords
- Visual Analog Scale, Hemiplegic Shoulder Pain, Ultrasound
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of shoulder ultrasound abnormalities
The total number of distinct shoulder abnormalities detected by ultrasonography on the hemiplegic side, including subacromial-subdeltoid bursitis, biceps tendon pathology, rotator cuff pathology, glenohumeral joint effusion, findings suggestive of adhesive capsulitis, and acromioclavicular joint degeneration. The outcome is expressed as a count of detected abnormalities, with a higher count indicating more coexisting ultrasound abnormalities.
Measured: At admission (single assessment on the same day as ultrasound)
Pain intensity at rest (VAS, 0-10)
Pain intensity at rest assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: At admission (single assessment on the same day as ultrasound)
Pain intensity during exercise (VAS, 0-10)
Pain intensity during exercise assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: At admission (single assessment on the same day as ultrasound)
Night pain intensity (VAS, 0-10)
Night pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: At admission (single assessment on the same day as ultrasound)
Secondary outcomes (6)
Presence of rotator cuff pathology
Presence or absence of rotator cuff abnormalities, including tendinopathy, partial-thickness tears, and full-thickness tears, assessed by shoulder ultrasonography on the hemiplegic side.
Measured: At admission (single assessment on the same day as pain evaluation)
Presence of biceps tendon pathology
Presence or absence of biceps tendon abnormalities, including tendinopathy and tenosynovitis, assessed by shoulder ultrasonography on the hemiplegic side.
Measured: At admission (single assessment on the same day as pain evaluation)
Presence of subacromial-subdeltoid bursitis
Presence or absence of subacromial-subdeltoid bursitis assessed by shoulder ultrasonography on the hemiplegic side.
Measured: At admission (single assessment on the same day as pain evaluation)
Presence of glenohumeral joint effusion
Presence or absence of glenohumeral joint effusion assessed by shoulder ultrasonography on the hemiplegic side.
Measured: At admission (single assessment on the same day as pain evaluation)
Ultrasonographic findings suggestive of adhesive capsulitis
Presence or absence of ultrasonographic findings suggestive of adhesive capsulitis in the hemiplegic shoulder.
Measured: At admission (single assessment on the same day as pain evaluation)
Presence of acromioclavicular joint degeneration
Presence or absence of acromioclavicular joint degenerative changes assessed by shoulder ultrasonography on the hemiplegic side.
Measured: At admission (single assessment on the same day as pain evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start17 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
- Investigators
- Nihal Tezel, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426965
- Sponsor's protocol ID
- AEŞH-BADEK1-2025-682
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22674236Huang 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.
PubMed 22854896
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Shoulder Ultrasound Findings and Pain Levels in Acute/Subacute Stroke Patients: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07426965
- Acronym / sponsor ID
- AEŞH-BADEK1-2025-682
- Conditions
- Hemiplegic Shoulder Pain, Stroke
- Keywords
- Visual Analog Scale, Hemiplegic Shoulder Pain, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemiplegic shoulder pain is a frequent complication after stroke and may be associated with structural abnormalities detectable by musculoskeletal ultrasound. This prospective cross-sectional observational study aims to evaluate the relationship between shoulder ultrasound abnormality score and pain severity in patients with post-stroke hemiplegic shoulder pain. Pain severity will be assessed using the Visual Analog Scale (VAS) for rest, exercise, and night pain. Shoulder ultrasound will be performed using a standardized scoring system to quantify structural abnormalities. The primary objective is to investigate whether ultrasound abnormality burden is associated with pain severity in different clinical conditions (rest, exercise, and night).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with stroke and hemiplegic shoulder pain who are admitted to the physical medicine and rehabilitation clinic of Ankara Etlik City Hospital will be included. Eligible patients are between 18 and 75 years of age and within 2 weeks to 6 months after stroke. All participants will undergo clinical assessment and shoulder ultrasound examination at admission.
Key inclusion criteria (4 listed)
- 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 State Examination (MMSE) score >25
Key exclusion criteria (4 listed)
- Patients with motor aphasia
- Patients with a history of previous surgery on the hemiplegic shoulder for any reason
- Patients with other medical conditions that may independently account for shoulder pain.
- Those with neurodegenerative diseases that cause impairment in cognitive functions, such as dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of shoulder ultrasound abnormalities
Time frame: At admission (single assessment on the same day as ultrasound)
The total number of distinct shoulder abnormalities detected by ultrasonography on the hemiplegic side, including subacromial-subdeltoid bursitis, biceps tendon pathology, rotator cuff pathology, glenohumeral joint effusion, findings suggestive of adhesive capsulitis, and acromioclavicular joint degeneration. The outcome is expressed as a count of detected abnormalities, with a higher count indicating more coexisting ultrasound abnormalities.
Pain intensity at rest (VAS, 0-10)
Time frame: At admission (single assessment on the same day as ultrasound)
Pain intensity at rest assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Pain intensity during exercise (VAS, 0-10)
Time frame: At admission (single assessment on the same day as ultrasound)
Pain intensity during exercise assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Night pain intensity (VAS, 0-10)
Time frame: At admission (single assessment on the same day as ultrasound)
Night pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
6 secondary outcomes
Presence of rotator cuff pathology
Time frame: At admission (single assessment on the same day as pain evaluation)
Presence of biceps tendon pathology
Time frame: At admission (single assessment on the same day as pain evaluation)
Presence of subacromial-subdeltoid bursitis
Time frame: At admission (single assessment on the same day as pain evaluation)
Presence of glenohumeral joint effusion
Time frame: At admission (single assessment on the same day as pain evaluation)
Ultrasonographic findings suggestive of adhesive capsulitis
Time frame: At admission (single assessment on the same day as pain evaluation)
Presence of acromioclavicular joint degeneration
Time frame: At admission (single assessment on the same day as pain evaluation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 22674236Pong 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.
- Background: PubMed 22854896Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nihal Tezel study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegic Shoulder Pain and Stroke, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of shoulder ultrasound abnormalities (time frame: At admission (single assessment on the same day as ultrasound)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07426965, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.