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CTRI Number  CTRI/2024/08/072056 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Other (Specify) [POINT-OF-CARE ULTRASOUND]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Point-of-Care Ultrasound to reduce time to diagnose Acute Shoulder Injuries 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. SOUBHIK CHAKRABORTY 
Designation  Junior Resident, Department of Emergency Medicine 
Affiliation  Department Of Emergency Medicine, AIIMS New Delhi 
Address  AIIMS- EM1, Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  8850065634  
Fax    
Email  rcky1999@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. TEJ PRAKASH SINHA 
Designation  Additional Professor, Department of Emergency Medicine 
Affiliation  Department Of Emergency Medicine, AIIMS New Delhi 
Address  1st Floor, Jai Prakash Narayan Apex Trauma Centre- A.I.I.M.S., New Delhi

New Delhi
DELHI
110029
India 
Phone  8518881749  
Fax    
Email  drsinha123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. SOUBHIK CHAKRABORTY 
Designation  Junior Resident, Department of Emergency Medicine 
Affiliation  Department Of Emergency Medicine, AIIMS New Delhi 
Address  AIIMS EM1, Department of Emergency Medicine, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  8850065634  
Fax    
Email  rcky1999@hotmail.com  
 
Source of Monetary or Material Support  
Department of Emergency Medicine, All India Institute of Medical Sciences (A.I.I.M.S.), New Delhi, India-110029 
 
Primary Sponsor  
Name  Department of Emergency Medicine AlIIMS New Delhi 
Address  Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi-110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soubhik Chakraborty  Jai Prakash Narayan Apex Trauma Centre- AIIMS, New Delhi  Emergency Room, Ground Floor, Department of Emergency Medicine.
New Delhi
DELHI 
8850065634

rcky1999@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Point of Care Ultrasound (POCUS) Group for diagnosing Acute Shoulder Injuries  POCUS Shoulder Scan algorithm followed by X-ray/ MRI as per the decision of clinical team  
Comparator Agent  Usual Care Group for Diagnosing Acute Shoulder Injuries  Clinical evaluation, Radiological investigation (X-ray shoulder +/-higher investigation as per the clinical team 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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

 
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