CTRI

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CTRI Number

CTRI/2023/12/060525 [Registered on: 19/12/2023] Trial Registered Prospectively

Last Modified On:

18/12/2023

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

The occurrence of musculoskeletal troubles in medical laboratory workers- a cross section study

Scientific Title of Study

Prevalence of musculoskeletal disorder in medical laboratory 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	Rina Sharma
Designation	1st year MPT
Affiliation	College of Physiotherapy Sumandeep Vidyapeeth deemed to be University
Address	College of physiotherapy,sumandeep vidhyapeeth deemed to be university, Piparia,Waghodia,Vadodara PG class room no.1, first floor, college of physiotherapy, sumandeep vidyapeeth,Waghodia, vadodara, gujarat Vadodara GUJARAT 391760 India
Phone	9016531481
Fax
Email	sharmarina2500@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Jaykumar Soni
Designation	Associate Professor
Affiliation	College of physiotherapy sumandeep vidhyapeeth deemed to be university
Address	College of physiotherapy,sumandeep vidhyapeeth deemed to be university, Piparia,Waghodia,Vadodara Department of Musculoskeletal and sports, First floor, PG 1 classroom, College of physiotherapy,sumandeep vidhyapeeth deemed to be university, Piparia,Waghodia,Vadodara Vadodara GUJARAT 391760 India
Phone	8866864021
Fax
Email	jaysoni.physio@gmail.com

Details of Contact Person
Public Query

Name	Dr Jaykumar Soni
Designation	Associate Professor
Affiliation	College of physiotherapy sumandeep vidhyapeeth deemed to be university
Address	College of physiotherapy,sumandeep vidhyapeeth deemed to be university, Piparia,Waghodia,Vadodara Department of Musculoskeletal and sports, First floor, PG 1 classroom, College of physiotherapy,sumandeep vidhyapeeth deemed to be university, Piparia,Waghodia,Vadodara Vadodara GUJARAT 391760 India
Phone	8866864021
Fax
Email	jaysoni.physio@gmail.com

Source of Monetary or Material Support

1. Patho care laboratory; 419/430 trivia complex, Natubhai circle, vadodara Gujarat-390007 2.Sterling Accuris laboratory; F-102 first floor shyamal complex, parivar cross road, waghodia road, vadodara-390019

Primary Sponsor

Name	Rina Sharma
Address	College of physiotherapy,sumandeep vidhyapeeth,deemed to be university,piparia,waghodia,vadodara 391760
Type of Sponsor	Other [Self-funded]

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
Rina Sharma	Pathological labs in vadodara	419/430 Trivia complex,natubhai circle vadodara 390007 F102,1st floor shayamal complex,parivaar char rasta,waghodia road, vadodara Vadodara GUJARAT	9016531481 sharmarina2500@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sumandeep Vidhyapeeth Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Medical Laboratory workers

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	Participants in age group of 18 to 45, Both male & female are included, Subjects who work for more than 6 hours in a day in laboratory set-up, Subjects who work in NABL accredited laboratories in Vadodara district, Subjects who work as Phlebotomist and laboratories assistant technician.

ExclusionCriteria

Details

Recent trauma / injuries,
chronic rheumatic diseases,
history of fracture in last 1 year,
any congenital spinal deformities.

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
Nordic questionnaire scale	1 time

Secondary Outcome

Outcome	TimePoints
Neck disability index Disability of arm, shoulder and hand Oswestry disability index Harris hip score Knee injury and osteoarthritis outcome score Foot and Ankle Disability Index	1 time

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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)

28/12/2023

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

In this study the medical laboratory workers will be approached and will be explained about the study. After collecting the personal information, the information will be collected by a modified Nordic questionnaire through self administered interview. As per the interpretation of Nordic questionnaire, the other questionnaires (Neck disability index, DASH, KOOSH, HHS, FADI ) wil be given to the subjects. The questionnaire comprises of multiple answer-type objective questions that whether episodes of pain or discomfort in different anatomical regions of the body four endpoints for each body site were defined.