NCT07426965

Brief 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 patients with post-stroke hemiplegic shoulder pain. Pain severity will be assessed using the Visual Analog Scale (VAS) for rest, movement, 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

February 17, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 17, 2026

Last Update Submit

February 17, 2026

Conditions

Keywords

Visual Analog ScaleHemiplegic Shoulder PainUltrasound

Outcome Measures

Primary Outcomes (1)

  • Association between shoulder ultrasound abnormality score and pain severity

    Relationship between total shoulder ultrasound abnormality score and Visual Analog Scale (VAS) pain scores (rest, movement, and night pain) assessed at admission.

    At admission (single assessment on the same day as ultrasound)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik Şehir Hastanesi

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 22674236BACKGROUND
  • 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.

    PMID: 22854896BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

February 17, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations