| CTRI Number |
CTRI/2024/07/071719 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of work posture and tasks amongst footwear industry workers and its association with musculoskeletal pain
|
|
Scientific Title of Study
|
Correlation of work related task analysis with musculoskeletal pain profile amongst footwear industry workers- 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 Victoria Kuttan |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
Department of Physiotherapy Integrated OPD 1st Floor room number 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka
Panvel Raigarh MAHARASHTRA 410209 India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
victoriak@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhila Natesan |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
Department of Physiotherapy Integrated OPD 1st Floor room number 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka
Panvel Raigarh MAHARASHTRA 410209 India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
anatesan@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Victoria Kuttan |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
Department of Physiotherapy Integrated OPD 1st Floor room number 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka
Panvel Raigarh MAHARASHTRA 410209 India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
victoriak@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
|
Department of Physiotherapy Integrated OPD 1st Floor room number 115 MGM Hospital, MGM School of Physiotherapy MGM Institute of Health Sciences Navi Mumbai, Kamothe , Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA 410209 India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy MGM Institute of Health Sciences Navi Mumbai |
| Address |
Department of Physiotherapy Integrated OPD 1st Floor room number 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka
Panvel Raigarh MAHARASHTRA 410209 India
|
| Type of Sponsor |
Private medical college |
|
|
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 Victoria Kuttan |
MGM School of Physiotherapy MGM Institute of Health Sciences |
Department of Physiotherapy Integrated OPD 1st
Floor room number 115 MGM Hospital Kamothe
Plot no 1 and 2 Navi Mumbai Taluka
Panvel Raigarh MAHARASHTRA 410209 India Plot
1 and 2 Sector 1
Raigarh
MAHARASHTRA |
02227437866
victoriak@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – MGM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Footwear Industry workers voluntarily participating in the study
Footwear industry workers both male and female with more than 5 years of experience in the age group of 18 to 59 years
|
|
| ExclusionCriteria |
| Details |
Workers with fractures, recent surgeries in the past month and neurological disorders
Workers with uncontrolled diabetes and hypertension
Pregnant and Post menopausal Women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Profile
Nordic Questionnaire
Visual Analogue scale
Posture analyis Rapid Upper extremity assessment
Posture analyis Rapid Entire body assessment
Task Analyis Occupational Repetitive Action checklist
Workstation observatory evaluation
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self adminstered checklist for ergonomic workplace observatory evaluation |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
20/08/2024 |
| 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="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
|
This cross sectional study aims to study the correlation between the prevalence of musculoskeletal pain profile and work-related tasks amongst footwear industry workers. Participants will undergo a comprehensive ergonomic assessment, which will include work posture analysis, task analysis, and work station analysis . Pain assessment will be done using Pain profile, Visual Analog Scale, and a Nordic questionnaire. The results of the study will help in formulating ergonomic strategies.
|