NCT06742359

Brief Summary

Shoulder pain is the third most common musculoskeletal pain complaint in the world with an incidence of 7-30%. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Imaging in impingement syndrome is usually based on different imaging modalities. X-ray, magnetic resonance imaging (MRI) and ultrasound are the most commonly used, and MRI is considered by many authors to be the most reliable imaging modality for evaluation of the rotator cuff because it allows evaluation of soft tissues as well as bony abnormalities such as subacromial osteophytes and acromioclavicular joint capsular hypertrophy. MRI allows the diagnosis of rotator cuff tears with greater interobserver reliability than ultrasound in assessing tear size, retraction and atrophy. Few studies have investigated the impact of pathologic findings on MRI on the degree of symptoms and functional impairment seen in these patients. The aim of this study was to investigate the relationship between shoulder pain and function and MRI findings in patients with subacromial impingement syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 16, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

Subacromial impingement syndromepainfunctionmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain Assessment: The visual analog scale is a one-dimensional measure of pain intensity and is widely used in adult populations, including rheumatologic patients. It can be used horizontally or vertically. The patient marks their pain on a 10 cm ruler with no pain at one end and the most severe pain at the other. Patients are asked to rank their pain intensity on a 10-point scale, where 0 = no pain, 5 = moderate pain and 10 = unbearable pain. In this method, the patient is told that there are two extremes and that they are free to mark any point in between. A higher value indicates more severe pain.

    2 months

Secondary Outcomes (1)

  • Function

    2 months

Study Arms (1)

patients with subacromial impingement syndrome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with subacromial impingement syndrome.

You may qualify if:

  • To be between the ages of 18-65
  • Shoulder pain for at least six weeks

You may not qualify if:

  • Presence of a rheumatologic disease,
  • Presence of neurological disease
  • Pregnancy
  • Symptomatic osteoarthritis of the shoulder, shoulder instability, pathologies of the tendon of the long head of the biceps, glenoid injuries and partial tears greater than 3 mm and full-thickness tears of the rotator cuff
  • Corticosteroid, hyaluronic acid and/or PRP injection in the shoulder area within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Duygu Silte Karamanlioglu, Medical doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

January 31, 2025

Primary Completion

March 30, 2025

Study Completion

April 30, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations