NCT05266391

Brief Summary

Since pain is usually accompanied by a substantial effect on daily life that results in the extensive use of healthcare resources. In subacromial impingement syndrome, shoulder pain affects the quality of life negatively by affecting upper extremity functions and interrupting night sleep. It is very important to control the pain in order to reduce the loss to the labor force and prevent the pain from becoming chronic. Various physical treatment methods such as ultrasound, hot pack, transcutaneous electrical nerve stimulation, etc., and injections or medical agents are recommended. This study aimed to compare the effects of ultrasound (US)-guided in comparison to landmark guided subacromial corticosteroids injection on shoulder range of motion (ROM), pain, and functional status in patients with subacromial impingement syndrome (SAIS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

Same day

First QC Date

February 28, 2022

Last Update Submit

February 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS)

    It is a scale scored from 0 to 10 to evaluate the severity of pain. Patients are asked to rate the pain they feel as '0' for no pain and '10' for the most severe pain they have encountered in their life

    Change from baseline visual analogue scale score at 1 month

Secondary Outcomes (3)

  • Shoulder joint range of motion (ROM)

    Change from baseline Shoulder joint range of motion at 1 month

  • Shoulder Pain and Disability Index (SPADI)

    Change from baseline Shoulder Pain and Disability Index at 1 month

  • The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)

    Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month

Study Arms (2)

group 1

patients who received US-guided subacromial corticosteroid injections

Other: subacromial corticosteroid injections

group 2

patients who underwent blind subacromial corticosteroid injections

Other: subacromial corticosteroid injections

Interventions

Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).

group 1group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with the diagnosis of Subacromial impingement syndrome who underwent subacromial corticosteroid injections in our interventional physiatry clinic between September 2017 and February 2018 were included in this study.

You may qualify if:

  • Shoulder posterolateral pain that increased with shoulder abduction,
  • Restriction of the shoulder passive and active range of motion (ROM),
  • Patients with positive Neer and Hawkins impingement test,
  • Patients with SAIS whose diagnosis was confirmed by magnetic resonance imaging (MRI), and
  • Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).

You may not qualify if:

  • Patients who received corticosteroid, local anesthetic, hyaluronic acid, and platelet-rich plasma injections in the shoulder in the last one year,
  • patients who had previous history of surgery or fracture in their thorax, neck, upper extremity or shoulder joint,
  • patients with a rheumatological, cognitive or psychiatric, central or peripheral neurological disease (stroke, spinal cord injury, brachial plexus injury, etc.),
  • patients whose MRI presented a partial or complete rotator cuff tear, calcific tendinitis or labral tear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Kadriye Ones, Prof

    Istanbul Physical Medicine Rehabilitation Training & Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 4, 2022

Study Start

June 1, 2018

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations