| CTRI Number |
CTRI/2024/05/066889 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of various causative factors of work related musculoskeletal injuries in pottery workers. |
|
Scientific Title of Study
|
Analysis of the various risk factors leading to work related musculoskeletal injuries amongst Pottery 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 |
Prathamesh Pol |
| Designation |
Post Graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of Community Physiotherapy,
11/12 Thube Park, Shivajinagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
7045839769 |
| Fax |
|
| Email |
polprathamesh678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suroshree Mitra |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy,Department of Community Physiotherapy,11/12 Thube Park Shivajinagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8087715596 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suroshree Mitra |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of Community Physiotherapy,11/12 Thube Park Shivajinagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8087715596 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube Park Shivajinagar Pune 411005 |
| 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 |
| Prathamesh Pol |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of Community Physiotherapy,11/12 Thube Park Shivajinagar
Pune
MAHARASHTRA |
7045839769
polprathamesh678@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pottery Workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Working Experience more than or equal to 3 years. |
|
| ExclusionCriteria |
| Details |
1. participants with recent infections, systemic disease and inflammatory conditions |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Rapid Entire Body Assessment
|
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Orebro Musculoskeletal Screening Questionnaire
|
At Baseline |
| Validated Self made Questionnaire |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="89"
Sample Size from India="89"
Final Enrollment numbers achieved (Total)= "97"
Final Enrollment numbers achieved (India)="97" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The workers who work in pottery are unaware of the risks involved with the unorganized sector, making them vulnerable to the many occupational risks that are prevalent and unaware of what steps to take to prevent them. The work environment of most of the pottery workshops was found to be inadequate in several studies with lack of practice of safety measures. The pottery workers have to work mostly in awkward sitting posture, and perform different activities that are repetitive leading to muscular pain. The musculoskeletal pain then induce the worker into specific postures and movements. Therefore there is need to analyze the potential risk factors that could negatively affect the Pottery workers for causing work-related musculoskeletal injuries. |