| CTRI Number |
CTRI/2025/02/080930 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Different Bag Types on Pain, Posture, and Musculoskeletal Health in Working Women |
|
Scientific Title of Study
|
Association Between Pain, Posture and Musculoskeletal Problems Using Different Types of Bags by Working Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanpreet Kaur |
| Designation |
PG Scholar |
| Affiliation |
Department of Physiotherapy Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9868956614 |
| Fax |
|
| Email |
sanpreetkaur0130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1, LGF, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Amity University of Health Allied Sciences, Amity University, Sector 125, Noida, Uttar Pradesh 201313 |
|
|
Primary Sponsor
|
| Name |
Sanpreet Kaur |
| Address |
Department of Physiotherapy, Amity University Health Allied Sciences, Amity University, Sector 125, Noida, Uttar Pradesh 201313 |
| 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 Pragya Kumar |
Amity Institute of Health Allied Sciences, Amity University |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125 Noida, Uttar Pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH |
9878529787
pkumar24@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Above 20 years working women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Female |
| Details |
Female participant
Working women between the ages of 20-59 years.
Women in professions that require the regular use of bags, including office workers, teachers, and healthcare professionals.
|
|
| ExclusionCriteria |
| Details |
Existing Musculoskeletal Disorders
Recent Injuries
Neurological Condition
Non-Bag Carriers
Pregnancy
Previous Surgery
Non-Compliance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Postural changes
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Musculoskeletal problems
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
26/02/2025 |
| 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="4"
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
|
Need of the study: The study aims to explore the relationship between the types of bags by working women and the prevalence of pain, posture and musculoskeletal problems. By examining different types of bags and their impact on posture and musculoskeletal health, this research seeks to provide insights that can inform better ergonomic practices and improve the well-being of working women.
Aim- To determine the association between pain, posture and musculoskeletal problems using different types of bags by working women.
Objectives– To assess pain, postural changes and musculoskeletal problems using different types of bags in working women.
Hypothesis-
Null hypothesis: there will be no significant difference in association between pain, posture and musculoskeletal problems among working women using different types of bags
Alternative hypothesis: there will be significant difference in association between pain, posture and musculoskeletal problems among working women using different types of bags
|