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CTRI Number  CTRI/2024/03/063488 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Developing screening method for de quervains tenosynovitis among computer users. 
Scientific Title of Study   Developing screening tool for de Quervain tenosynovitis among computer users. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeet Dey 
Designation  Postgraduate Student 
Affiliation  Amity Institute of Physiotherapy 
Address  Avantika pg Room 204 Noida sec 126 uttar pradesh
Amity university noida uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  7209786952  
Fax  0  
Email  jeet.dey@s.amity.edu  
 
Details of Contact Person
Scientific Query  
Name  Rabab Kaur 
Designation  Assistant professor  
Affiliation  Amity University Noida 
Address  Room nunber LG03 Amity Institute of Physiotherapy Amity University Noida Uttar pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  9654478155  
Fax  0  
Email  rkaur4@amity.edu  
 
Details of Contact Person
Public Query  
Name  Rabab Kaur 
Designation  Assistant professor  
Affiliation  Amity University Noida 
Address  Room number LG03 Amity Institute of Physiotherapy Amity University Noida Uttar pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  9654478155  
Fax  0  
Email  rkaur4@amity.edu  
 
Source of Monetary or Material Support  
Amity University, Noida, Uttar Pradesh. Sector 125 
 
Primary Sponsor  
Name  Jeet Dey 
Address  Amity Institute of Physiotherapy Amity University Noida 
Type of Sponsor  Other [self] 
 
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 Jyoti Bhatia  Sumitra Hospital  Department of physiotherapy
Gautam Buddha Nagar
UTTAR PRADESH 		 9899163395

lrjyoti@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumitrahospital,uttarpradesh  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  An individual who experiences discomfort in the wrist joint and spends five to six hours per day, five days a week, working on a computer. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Computer usage more than 5 hours for 5 to 6 days in a week, diagnosed case of de quervain since 1 month, presence of pain and discomfort in thumb region, pain worsen during work and difficulty in gripping objects, numeric pain rating scale less than 7 and patients willing to participate 
 
ExclusionCriteria 
Details  Previous history of wrist trauma or surgery, Rheumatoid arthritic patients, patients having any neurological deficits, patients on any pain reliving medication since 1 month, person having any congenital deformity, patients outside the age bracket, and patients not willing to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To create a rapid assessment tool that aids in prompt identification and treatment of the disease.
 		 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Cost effectiveness  8 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   11/03/2024 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

 De Quervain’s tenosynovitis is a painful and debilitating musculoskeletal disorder that often afflicts computer users due to repetitive thumb and wrist movements. The study employs a multidisciplinary approach, combining clinical assessments, ergonomic evaluations, and self-reported data to create a comprehensive screening instrument. Additionally, the research explores the prevalence of De Quervain’s tenosynovitis within the computer user population and investigates the associated risk factors. The findings of this research contribute to the understanding and management of this condition, potentially reducing its impact on computer-dependent populations and enhancing their overall well-being.

 
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