| CTRI Number |
CTRI/2024/09/073671 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors causing work-related muscle and joint problems among professional auto-drivers in Udupi district, Karnataka. |
|
Scientific Title of Study
|
Factors associated with work-related musculoskeletal disorders among professional auto-drivers in Udupi district, Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheryl Rachel Mathew |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8921341640 |
| Fax |
|
| Email |
sherylmathew123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shovan Saha |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880059426 |
| Fax |
|
| Email |
shovan.saha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shovan Saha |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880059426 |
| Fax |
|
| Email |
shovan.saha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Sheryl Rachel Mathew |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India - 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Shovan Saha |
Manipal College of Health Professions, Manipal Academy of Higher Education |
Department of Occupational Therapy, 3rd floor, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India - 576104
Udupi
KARNATAKA |
9880059426
shovan.saha@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z579||Occupational exposure to unspecified risk factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Working duration: 8 hours and above
• Ability to read and write |
|
| ExclusionCriteria |
| Details |
• Previous injuries or trauma, such as, slip or fall accidents unrelated to professional driving duties.
• Congenital musculoskeletal abnormalities and prior limb surgery.
• Other neurological and orthopedic conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the factors causing WMSDs among auto drivers. |
5 months from time of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the prevalence of WMSDs among auto-drivers in the Udupi district, Karnataka.
|
5 months from the time of data collection |
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
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)
|
17/09/2024 |
| 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="5"
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
|
Title of the project: Factors associated with work-related musculoskeletal disorders among professional auto-drivers in Udupi district, Karnataka Aims & objectives: AIM: To determine the factors associated with work-related musculoskeletal disorders among auto drivers in Udupi district, Karnataka. OBJECTIVES: -
To identify the factors causing WMSDs among auto drivers. -
To assess the prevalence of WMSDs among auto-drivers in the Udupi district, Karnataka. - To profile the involved joints causing WMSDs among auto-drivers.
Study period: 8 months - July 2024 to March 2025
Sample size: At 5% level of significance with an anticipated prevalence of 50% (p) and a margin of error 5% (d), the minimum sample size required to identify the risk factors for musculoskeletal disorders among auto- drivers in Udupi district, Karnataka is ð§=#ð™ ðŸ (ð©)(ðŸï¿½â€™ð©) %ð¢.ðž.ð§=(ðŸ.ðŸ—ðŸ”)ðŸ (ðŸŽ.ðŸ“)(ðŸï¿½â€™ðŸŽ.ðŸ“)%=�’ðŸ–📠�’�%# ðŸ ðŸ"ðŸ ð # (ðŸŽ.ðŸŽðŸ“)ðŸ However, the population size is presently anticipated to be 650. Incorporating the finite population correction, 20% drop-out, we have. ð¬ð¬ = #(�’ðŸ–ðŸ“)(ðŸ”ðŸ“ðŸŽ) % = #ðŸðŸ“ðŸŽðŸðŸ“🎠= : (ð§)(ð) < = ðŸï¿½â€™ðŸ ~ðŸðŸ–�’ �’ðŸ–ðŸ“+(ðŸ”�’ðŸ—) ðŸðŸŽï¿½â€™ï¿½â€™ % ð§+(ð�’ðŸ) ðŸŽ.ðŸ–ðŸ“
The sample size required for the study is 284 auto-drivers. Methods:
Inclusion and exclusion criteria: Inclusion criteria: - Age–18to65years
- Working duration: 8 hours and above
- Ability to read and write
Exclusion criteria:
-
Previous injuries or trauma, such as, slip or fall accidents unrelated to professional driving duties. -
Congenital musculoskeletal abnormalities and prior limb surgery. -
Other neurological and orthopedic conditions. Statistical methods:
-
• Statistical analysis will be conducted using JAMOVI software (v2.3).
• Frequency tables and percentages will assess musculoskeletal disorder risk prevalence among auto-drivers. Descriptive statistics, mean, standard deviation, median, and interquartile range will be used for quantitative variables, adjusting for skewness.
• Parametric tests like independent t-tests and one-way ANOVA will compare musculoskeletal disorder risks among auto-drivers in Udupi district, Karnataka, across socio-demographic groups. Non-parametric tests will be used if normality and variance homogeneity assumptions
are violated. Correlation and logistic regression will explore socio-demographic factors’ impact on outcome variables. Tools used: Nordic musculoskeletal questionnaire -
Nordic Musculoskeletal Questionnaire (NMQ) (Kuorinka et al., 1987) is a validated and reliable tool, suitable to use in epidemiologic studies. -
The test-retest reliability of the questionnaire used to ascertain the musculoskeletal symptom- related information of the industrial workers fared well by having kappa values of 0.40 to 0.85 or greater, which is good to excellent. -
Along with being repeatable and sensitive, it is also a standardized, recognized, convenient, and cost-effective form of test. -
NMQ contains 2 sections, a general questionnaire having 40 items, body map, supplementary questions and functional impacts due to the musculoskeletal difficulties. Procedure: • After CTRI registration and approval, Union leaders will recruit participants based on screening criteria, distributing consent forms for completion either at the association office or auto stands in Manipal and Udupi. Participants agreeing to join will complete the questionnaire in 15-20 minutes. • Any queries will be addressed with the investigator’s assistance.
• Data collection will continue until the desired sample size is achieved. • Subsequently, data analysis, dissertation writing, submission, manuscript preparation, and submission to a suitable journal will follow.
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