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CTRI Number  CTRI/2024/09/074508 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Long-term Thumb Pain in Rifle Shooters of the Indian Armed Forces: Prevalence and Impact on Quality of Life 
Scientific Title of Study   Prevalence and Associated risk factors of chronic thumb pain on overall quality of life among Riffle Shooters in Indian Armed Forces- A cross sectional study 
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 Mohammad Sidiq 
Designation  Associate Proffesor 
Affiliation  Galgotias University 
Address  Room No.B316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit Gautam Buddha Nagar, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Sidiq 
Designation  Associate Proffesor 
Affiliation  Galgotias University 
Address  Room No.B316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit Gautam Buddha Nagar, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anshika Suyal 
Designation  Student 
Affiliation  Galgotias University 
Address  Room No.E005, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit Gautam Buddha Nagar, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  07017752792  
Fax    
Email  anshika.21SMAS1010040@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Yamuna Expry, Opposite International Circuit, Greater Noida, Uttar Pradesh, 2032021 
 
Primary Sponsor  
Name  Galgotias University 
Address  Plot No.2 Sector 17-A, Opposite Buddha International Circuit, Yamuna Expressway, Greater Noida, India 
Type of Sponsor  Research institution 
 
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 Mohammad Sidiq  Galgotias University  Room No. B317, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No.2 Sector 17-A, Opposite Buddha International Circuit, Yamuna Expressway, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH 		 6006204628

sidufatima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M654||Radial styloid tenosynovitis [de Quervain],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NIL 
Comparator Agent  NA  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Individual with chronic thumb pain more than 3 months.
2. Adults aged between 20- 45.
3. Individual with lifting and operating rifle for longer duration.
4. Males are included in this study.
 
 
ExclusionCriteria 
Details  1.Patient with any hand and wrist surgery.
2. Patient having other condition like RA, OA, CTS, trigger thumb.
3. Patient with any neurological disorder.
4. Individual who have had surgical release of first dorsal compartment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NPRS
DASH questionnaire 		 At base line. 
 
Secondary Outcome  
Outcome  TimePoints 
SF- 36 questionnaire  At base line 
 
Target Sample Size   Total Sample Size="243"
Sample Size from India="243" 
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)   18/10/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anshika.21SMAS1010040@galgotiasuniversity.edu.in].

  6. For how long will this data be available start date provided 30-12-2024 and end date provided 30-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This cross-sectional research will be conducted to evaluate the prevalence of chronic thumb pain in rifle shooters in the Indian Armed Forces, the related risk factors of chronic thumb pain, and how these variables influence the quality of life. Chronic pain experienced in the thumb is almost universal among shooters who engage in repetitive arm cradling from firearm handling. Chronic thumb pain has the potential to affect the shooters’ well-being and performance. The risk factor section identifies grip pressure, shooting technique, and shooting training intensity that can lead to thumb pain. The shooter research study reviewed these factors and how thumb injured impacted their daily activities, mental health, and job performance. The objective of the study is to contribute to developing preventive measures and therapeutic approaches to promote improved quality of life for shooters in the Indian Armed Forces while using firearms. 
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