NCT06665139

Brief Summary

Pain intensity will be measured with visual analog scale. Sonographic severity grade of shoulder impingement syndrome, serratus anterior muscle, upper trapezius and middle trapezius will be measured with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 25, 2024

Last Update Submit

October 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • sonographic severity grade of shoulder impingment syndrome

    The distance between the acromion and the greater tuberosity will be measured in both neutral and dynamic positions, and the disease severity will be assessed according to the ratio between these two data.

    baseline

Study Arms (2)

impigment

Patients diagnosed with impingement and meeting the criteria will be included,

Diagnostic Test: muscle thickness

healty

the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease.

Diagnostic Test: muscle thickness

Interventions

muscle thicknessDIAGNOSTIC_TEST

Pain intensity will be measured with visual analog scale, sonographic severity grade of shoulder impingement syndrome, muscle thickness of serratus anterior muscle, upper trapezius and middle trapezius with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers.

healtyimpigment

Eligibility Criteria

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

Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease.

You may qualify if:

  • years
  • Cognitive ability to understand test instructions
  • Symptom duration longer than 1 month
  • At least two positive Neer, Hawkins and painful arch tests
  • for healty volunteers
  • years
  • cognitive ability to understand test instructions
  • negative impingment test

You may not qualify if:

  • Fibromyalgia
  • cervical radiculopathy
  • those who have received injections or physical therapy in the last month
  • Those with a disorder that may affect shoulder joint range of motion and muscle mass (previous fracture, surgery, subluxation)
  • BMI over 35
  • inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cansın Medin Ceylan

Istanbul, Bahcelievler, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

  • cansın medin ceylan, MD

    Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 30, 2024

Study Start

September 1, 2024

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations