| CTRI Number |
CTRI/2025/10/095522 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Body Pain, Tiredness, and Stress Among Truck Drivers and Auto Drivers exposed to Long hours of driving. |
|
Scientific Title of Study
|
Prevalence of Musculoskeletal disorders among Truck drivers and Auto-Rickshaw drivers: 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 |
Kshweth Mayankh Bose |
| Designation |
Undergraduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
2.7, Second Floor, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
7338926895 |
| Fax |
|
| Email |
mayankhkshweth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chrysolyte Mohanan |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty room, Second floor, Sri Ramachandra Faculty of Physiotherapy, SRIHER, Porur, Chennai-116
SRIHER,PORUR,Chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
9444934432 |
| Fax |
|
| Email |
chrysolyte@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chrysolyte Mohanan |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty Room, Second floor, Sri Ramachandra Faculty of Physiotherapy, SRIHER, Porur, Chennai-116
SRIHER,PORUR,Chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
9444934432 |
| Fax |
|
| Email |
chrysolyte@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chrysolyte Mohanan |
Sri Ramachandra Institute of Higher Education and Research |
Sri Ramachandra Faculty of Physiotherapy,
SRIHER,PORUR,Chennai 116
Sri Ramachandra Faculty of Physiotherapy,
SRIHER, PORUR, Chennai 116
Chennai
TAMIL NADU |
9444934432
chrysolyte@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee (for UG and Non-Med PG Students), SRIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal Disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Male drivers, aged between 25 and 45 years, with at least one year of professional driving experience.
2.Participants who can understand and respond to the questionnaires, and are willing to provided informed consent over the study will be included.
|
|
| ExclusionCriteria |
| Details |
1.Drivers with recent fractures, neurological or psychiatric conditions, ongoing musculoskeletal treatment.
2.Drivers with less than one year of driving experience.
3.Drivers who face difficulty in understanding the questions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Fatigue, Psychological impact |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/10/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Truck and auto-rickshaw drivers are exposed to occupational risk factors such as prolonged driving hours, suboptimal ergonomics, and whole-body vibrations, which may increase their risk for musculoskeletal disorders, fatigue, and psychological stress. The health outcomes for this occupational group remain under-investigated within the Indian context. The primary objective is to assess the prevalence of musculoskeletal disorders among truck and auto-rickshaw drivers. |