| 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
|
|
|
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
|
|
|
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 |