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Clinical Trials/CTRI/2024/08/072056
CTRI/2024/08/072056
Not yet recruiting
Not Applicable

Efficacy of Point-of-Care Ultrasound in reduction of time to diagnose Acute Shoulder Injuries as compared to Usual Care in adult trauma patients presenting to Emergency Department: An Open Label Randomized Control Trial

Department of Emergency Medicine AlIIMS New Delhi1 site in 1 country60 target enrollmentStarted: August 20, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Department of Emergency Medicine AlIIMS New Delhi
Enrollment
60
Locations
1
Primary Endpoint
To determine the median time in diagnosing shoulder injuries (Proximal humerus fracture, rotator cuff injuries & glenohumeral joint dislocations, scapular and clavicular fractures.) in Point-of-Care Ultrasonography group vs Usual Care group

Overview

Brief Summary

Acute shoulder injuries can lead to significant pain, functional impairment, and reduced quality of life. Prompt recognition, accurate diagnosis, and appropriate management are crucial to prevent long-term complications and facilitate optimal recovery.

A study published in the American Journal of Sports Medicine estimated the annual incidence of shoulder injuries in the United States to be approximately 14.7 per 1,000 person-years, with the highest rates observed in individuals aged 18 to 44 years.

 Point-of-Care Ultrasound (POCUS) provides real-time imaging, and can assess for abnormalities such as impingement, tendon tears, or instability during active movement. It may offer cost savings as compared to repeat radiographs and MRI and can provide real-time guidance for therapeutic interventions, such as injections or aspirations. Several studies have demonstrated the diagnostic accuracy and reliability of POCUS in the evaluation of shoulder injuries, including its ability to detect rotator cuff tears, subacromial/subdeltoid bursitis, and glenohumeral joint effusion. It is radiation-free, making it a safer imaging modality, particularly for pregnant women and pediatric patients and allows for interactive discussion with patients during the imaging process so that they can actively participate in shared decision-making regarding their treatment plan.

There have been no studies in India and very limited studies worldwide bringing out the reduction in time by POCUS as compared to conventional diagnostic bundle to diagnose acute shoulder trauma, which is an emergency

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients with complaints of injury to shoulder having age more than or equal to 18 years Shoulder injuries of less than 48 hours duration Patients willing to give consent.

Exclusion Criteria

  • Patients with non traumatic shoulder related complaints Age less than 18 years Hemodynamically unstable patients or on Mechanical Ventilation Patients with known diagnosis or already treated outside Patients with prior operation in the shoulder region.

Outcomes

Primary Outcomes

To determine the median time in diagnosing shoulder injuries (Proximal humerus fracture, rotator cuff injuries & glenohumeral joint dislocations, scapular and clavicular fractures.) in Point-of-Care Ultrasonography group vs Usual Care group

Time Frame: At Baseline

Secondary Outcomes

  • To study the time taken for initiation of definite management in both the groups(At baseline)
  • To find out if there is any change in management decision(At baseline)

Investigators

Sponsor
Department of Emergency Medicine AlIIMS New Delhi
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr. SOUBHIK CHAKRABORTY

Department Of Emergency Medicine, AIIMS New Delhi

Study Sites (1)

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