| CTRI Number |
CTRI/2024/05/067552 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
compare how many farmers growing wheat and vegetables have wrist pain and how bad it is and what things might be causing it. |
|
Scientific Title of Study
|
Comparing prevalence and intensity of wrist pain and associated risk factors among wheat and vegetable growing farmers-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 |
Sudhi Kumari |
| Designation |
BPT Final Year Student |
| Affiliation |
Galgotias Uniiversity |
| Address |
E005 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddha International Circuit
E005 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddha International Circuit
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8340396693 |
| Fax |
|
| Email |
sudhikumari2710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
B-316 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh, India
B-316 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08859957729 |
| Fax |
|
| Email |
Monika0608sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
B-316 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh, India
B-316 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08859957729 |
| Fax |
|
| Email |
Monika0608sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Research And Development Cell Galgotias university |
| Address |
B-316 Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Opposite Buddh International Circuit, Gautam Buddh Nagar, Uttar Pradesh, India |
| Type of Sponsor |
Research institution |
|
|
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 Monika Sharma |
Galgotias University |
Room No E004 Department of Physiotherapy School of Allied
Health Sciences Plot No.2, Sector 17-A
Yamuna Expressway,
Greater Noida, Opposite Buddha International Circuit, Gautam Buddha Nagar,
Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH |
8859957729
Monika0608sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants who are of age group 25-65 including both male and female. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 25-65
2.Farmers
3.Male and Females both
4.Farmers who grow wheats, vegetables
|
|
| ExclusionCriteria |
| Details |
1. Pregnant female
2.Any pathological condition
3.Post surgery
4.Post trauma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient Rated Wrist Evaluation (PRWE) Score will be used to measure the wrist pain and disability in activities of daily living. |
Baseline 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="377"
Sample Size from India="377"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a correlational study. The purpose of this study will be to find out the effect of farming on the wrist joint and how this will affect the daily activities of farmers with doing their work and how this affects the strength of your wrist joint. |