FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/08/035347 [Registered on: 03/08/2021] Trial Registered Prospectively
Last Modified On: 18/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Shear wave elastography in assessing Tendinopathy in an Indian population 
Scientific Title of Study   Role of Shear wave elastography in assessing tendinopathy of supraspinatus tendon and muscle, tendoachilles and common extensor tendon of elbow in an Indian population. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anant Batra 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Radiodiagnosis and Imaging, Kasturba Medical college, Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9582817779  
Fax    
Email  batra.anant@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajagopal K V  
Designation  PROFESSOR  
Affiliation  DEPARTMENT OF RADIODIAGNOSIS AND IMAGING, KASTURBA MEDICAL COLLEGE, MANIPAL 
Address  Department of Radiodiagnosis and Imaging, Kasturba Medical college, Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9448158901  
Fax    
Email  rajagopal.kv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vinay Raju 
Designation  Assistant Professor 
Affiliation  DEPARTMENT OF RADIODIAGNOSIS AND IMAGING, KASTURBA MEDICAL COLLEGE, MANIPAL  
Address  Department of Radiodiagnosis and Imaging, Kasturba Medical college, Manipal Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9686656575  
Fax    
Email  drvinayraju@gmail.com  
 
Source of Monetary or Material Support  
KASTURBA MEDICAL COLLEGE MANIPAL 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal  
Address  Kasturba Medical college Manipal - 576104 Udupi 
Type of Sponsor  Private 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 Anant Batra  Kasturba Hospital  Room No. 12, Department of Radiodiagnosis and Imaging, Kasturba Medical College, Manipal, Udupi, Karnataka
Udupi
KARNATAKA 		 9582817779

batra.anant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M679||Unspecified disorder of synovium and tendon, (2) ICD-10 Condition: M679||Unspecified disorder of synovium and tendon,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  CASES :
1. People with complaint of shoulder pain, suspected tendoachilles abnormality or tenderness of lateral epicondyle.

CONTROLS :-
1. Normal side of the patient with shoulder pain, suspected tendoachilles abnormality or
tenderness of lateral epicondyle
2. If both sides involved, people coming for ultrasound other than shoulder, heel or elbow
but with no history of shoulder pain, pain at the back of heel or tenderness of lateral
epicondyle.
3. Normal appearance of Tendon on conventional US.
4. Written informed consent.
 
 
ExclusionCriteria 
Details  People with history of fracture, surgery or any known case of other systemic
musculoskeletal disorder.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate supraspinatus (SSP) muscle and tendon, tendoachilles and common extensor tendon of elbow using shear wave elastography, define shear-wave velocity (SWV) and stiffness values for tendinopathy.  1 year 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate supraspinatus (SSP) muscle and tendon, tendoachilles and common extensor tendon of elbow using shear wave elastography, define shear-wave velocity (SWV) and stiffness values for normal tendon.  1 year 6 month 
 
Target Sample Size   Total Sample Size="202"
Sample Size from India="202" 
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)   05/08/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   AIMS 
To evaluate supraspinatus (SSP) muscle and tendon, tendoachilles and common extensor tendon of elbow using shear wave elastography (SWE), define shear-wave velocity (SWV) and stiffness values for normal tendon and tendinopathy. 

OBJECTIVES
1. To measure stiffness and SWV values using SWE in people with normal supraspinatus muscle and tendon, tendoachilles tendon and common extensor tendon of elbow. 
2. To measure stiffness and SWV values using SWE in people with abnormal supraspinatus muscle and tendon, tendoachilles tendon and common extensor tendon of elbow.

JUSTIFICATION OF STUDY : Rotator cuff abnormalities are quite common in our population and like many musculoskeletal diseases, the abnormalities shown by complementary test and imaging and conventional US does not always correlate with symptoms. SWE is relatively a new technology that gives objective data of the tissue of Tendons. This helps in good assessment of the tissue quality of tendon for preoperative evaluation and treatment planning. As there is still lack of standardization for accurately evaluating the results, multiple studies need to be done in larger population. So we would like to conduct this study on our Indian Population and aid in standardization by measuring SWV and stiffness values of Supraspinatus Tendon, Tendoachilles and common extensor tendon of elbow for both normal as well as tendinopathic tendon. 
 
Close