FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/10/046465 [Registered on: 13/10/2022] Trial Registered Prospectively
Last Modified On: 25/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational analytical study 
Study Design  Other 
Public Title of Study   A study to know the factors associated with shoulder pain so that we can take the avoidable step to decrease incidence of shoulder pain.  
Scientific Title of Study   Factors associated with higher Disability and Dysfunction of shoulder in patients Of Subacromial Impingement syndrome and Rotator Cuff Tear 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitesh Gahlot 
Designation  Associate professor (Orthopaedics) 
Affiliation  AIIMS jodhpur 
Address  Associate Professor, Department Of Orthopaedics, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342001
India 
Phone  9116096665  
Fax    
Email  doc.nitesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitesh Gahlot 
Designation  Associate professor (Orthopaedics) 
Affiliation  AIIMS Jodhpur 
Address  Department of Orthopaedics, AIIMS JODHPUR

Jodhpur
RAJASTHAN
342001
India 
Phone  9116096665  
Fax    
Email  doc.nitesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amir Suhail 
Designation  Junior Resident, Orthopaedics 
Affiliation  AIIMS Jodhpur 
Address  Department of Orthopaedics, AIIMS JODHPUR

Jodhpur
RAJASTHAN
342001
India 
Phone  9758276686  
Fax    
Email  suhail.amir22@gmail.com  
 
Source of Monetary or Material Support  
AIIMS JODHPUR 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  AIIMS Jodhpur 
Type of Sponsor  Research institution and hospital 
 
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 Amir Suhail  AIIMS JODHPUR  Department of Orthopaedics, OPD ground floor c block
Jodhpur
RAJASTHAN 		 9758276686

suhail.amir22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1. At least one test of Rotator cuff tear is positive
(Painful arc test) or(Neers Impingement test)or (Hawkins kennedy test)
2. Shoulder pain of atleast 6 weeks.
3. X ray and MRI done for Diagnosis
4.Age> 18 years and < 70 years 
 
ExclusionCriteria 
Details  1. Rheumatoid Arthritis
2. Symptomatic Osteoarthritis of shoulder
3. shoulder instability
4. biceps long tendon pathologies
5. glenoid injury due to trauma 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
ASES SCORE, VAS and QUICKDASH SCORE   18 WEEKS  
 
Secondary Outcome  
Outcome  TimePoints 
ASES SCORE, VAS SCORE AND QUICKDASH SCORE WITH HIGHER DISABILITY  18 WEEKS 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   CTRI 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  LINK

  6. For how long will this data be available start date provided 21-09-2022 and end date provided 01-09-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is an observational analytical study to find out the risk factors associated with higher functional impairment and disability in patients with shoulder pain due to subacromial impingement and rotator cuff tear. 
Close