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CTRI Number  CTRI/2019/05/018892 [Registered on: 01/05/2019] Trial Registered Prospectively
Last Modified On: 30/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Occurrence of joint and muscle pain and evaluation of working posture amongst the sewing machine operators in a garment industry. 
Scientific Title of Study   Prevalence of work related musculoskeletal disorders and analysis of working posture using rapid entire body assessment tool amongst the sewing machine operators in a garment industry: A cross sectional study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pothiraj Pitchai 
Designation  Associate Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of community physiotherapy, MGM College of Physiotherapy, Sector 1, Kamothe, Navi Mumbai.
Sector 1, Kamothe.
Raigarh
MAHARASHTRA
410209
India 
Phone  9769497441  
Fax    
Email  pothirajpt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  pothiraj pitchai 
Designation  Associate Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of Community Physiotherapy, MGM College of Physiotherapy, Sector 1, Kamothe, Navi Mumbai.
Sector 1, Kamothe.
Raigarh
MAHARASHTRA
410209
India 
Phone  09769497441  
Fax    
Email  pothirajpt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kavita Bosmia 
Designation  student 
Affiliation  MGM College of Physiotherapy 
Address  Department of Community Physiotherapy, MGM College of Physiotherapy, Sector 1, Kamothe, Navi Mumbai.
Department of Community Physiotherapy, MGM College of Physiotherapy, Sector 1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India 
Phone  9175666463  
Fax    
Email  kavitabosmia@gmail.com  
 
Source of Monetary or Material Support  
MGM College of Physiotherapy, Kamothe. 
 
Primary Sponsor  
Name  MGM College of Physiotherapy 
Address  Sector 1, Kamothe, Navi Mumbai 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bosmia Kavita Kiritkumar  MGM Hospital  Physiotherapy OPD, Room no 55, MGM Hospital, Sector 1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA 
9175666463

kavitabosmia@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Review Committee, MGM College of Physiotherapy, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Musculoskeletal disorders 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Sewing machine operators having experience of at least 1 year.
2. Motorized pedal sewing machine.
3. Minimum of 8 -10 hours of work per day.
4. Tailors primarily involved in stitching garments.
6. Tailors performing task by sitting on the chair.  
 
ExclusionCriteria 
Details  1. Musculoskeletal pain prior to entering sewing machine operation
profession.
2. Spinal, lower limb and upper limb surgeries.
3. Suffering from inflammatory joint diseases.
4. Pregnant tailors.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Örebro Musculoskeletal pain questionnaire.
2. Rapid entire body assessment
(REBA).
3. Quick exposure Check Tool (QEC)
4.International Physical Activity Questionnaire. 
1 day 
 
Secondary Outcome  
Outcome  TimePoints 
1.International Physical Activity Questionnaire.  1 day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/05/2019 
Date of Study Completion (India) 31/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pothirajpt@gmail.com].

  6. For how long will this data be available start date provided 21-05-2021 and end date provided 21-05-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
This Cross-sectional study aimed to find out the prevalence of WMSDs, the working posture using REBA and secondarily assessed the different level of PA and its influence on development of WMSDs amongst the sewing machine operators. The study was approved by the institutional ethics committee and was conducted in a garment industry consisting of 550 sewing machine operators in garment department working in various units. After explanation of purpose of study those participants who fulfilled the criteria’s were recruited. 100 participants voluntarily participated in the study. Consent was obtained from these participants. Outcome measures used were Örebro Musculoskeletal pain questionnaire (ÖMPQ) for prevalence, Rapid Entire Body Assessment tool (REBA) for posture evaluation, Quick Exposure Check tool (QEC) to identify the exposure risk of body part for development of WMSDs and International Physical Activity Questionnaire (IPAQ) to find the level of PA of workers in their daily routine. Data was collected, coded, tabulated and analyzed using SPSS 24 software. Descriptive statistics - frequency distribution in percentage was calculated, to find out association of WMSDs chi- square was applied and to find out relationship Spearman Rank correlation coefficient (r) was calculated. The study revealed 70% of the participants suffered from WMSDs, low back pain was the commonest complaint and many of participants had anxiety and depression due to their pain. 24.29% also complained of eye discomforts. The study also demonstrated that 33% of participants had varying levels of stress.
The participants had poor posture that needed investigation and immediate change in their workstation, with 55% having high risk posture scoring between 8 – 10 and 44% of them had REBA score ≥11. Neck had very high exposure risk for the development of WMSDs, whereas back, shoulder/arm and hand/wrist had high exposure risk. Lastly, most of the participants had high PA, however no or little positive association was found between PA and WMSDs. The study concluded high prevalence of WMSDs amongst the sewing machine operators and they have poor posture with very high-risk exposure to neck region. Additionally, PA had little or no positive influence in the commencement of WMSDs.
 
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