| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pothirajpt@gmail.com].
- 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.
- 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. |