The proposed study design is a cluster randomized controlled trial with two groups (control and intervention groups) where office workers in the University of Malaya that fulfill a strict inclusion and exclusion criteria was selected into this trial. Each individual faculty or academic center will be considered as an individual cluster. This study will be going on for 12 months with data collection at baseline, sixth month, and twelfth month points. The control group was given a basic occupational health talk while the intervention group was given an active ergonomic training which comprises of several intervention packages.
General information
Acronym
PWRULDCRCT
IRCT registration information
IRCT registration number:IRCT2015102624720N1
Registration date:2015-11-04, 1394/08/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Muhamad Hazizi Muhamad Hasani
Name of organization / entity
University of Malaya
Country
Malaysia
Phone
+60(3)79674756
Email address
muhamadhazizi@siswa.um.edu.my
Recruitment status
Recruitment complete
Funding source
Post-graduate Research Grant, University of Malaya
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
PREVENTION OF WORK RELATED UPPER LIMB MUSCULOSKELETAL DISORDERS: A CLUSTER RANDOMIZED CONTROLLED TRIAL
Public title
Trial Research To Prevent Muscles, Bone, and Nerve Diseases of The Upper Limb Among Workers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion - Computer users of more than 20 hours per week, age 18-65 years old, office workers
Exclusion - pregnant lady, existing upper limb musculoskeletal disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Two-staged cluster sampling that followed guideline for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University Malaya Medical Centre, Medical Ethics Committee
Street address
University Malaya Medical Centre
City
Lembah Pantai
Postal code
59100
Approval date
2014-05-01, 1393/02/11
Ethics committee reference number
20153-1128
2
Ethics committee
Name of ethics committee
National Medical Research Register
Street address
Ministry of Health Malaysia, c/o Institute for Health Management, Jalan Rumah Sakit, Bangsar
City
Kuala Lumpur
Postal code
59000
Approval date
2014-09-01, 1393/06/10
Ethics committee reference number
NMRR-14-131-19723
Health conditions studied
1
Description of health condition studied
Upper Limb Musculoskeletal Disorders
ICD-10 code
M60-M79
ICD-10 code description
Diseases of musculoskeletal system and connective tissues
Primary outcomes
1
Description
Incidence rate
Timepoint
After 1 year
Method of measurement
Diagnosis by clinician
Secondary outcomes
1
Description
Pain and discomfort score
Timepoint
After 1 year
Method of measurement
DASH Questionnaire (Disability of Arm, Shoulder and Hand)
Intervention groups
1
Description
Intervention - Ergonomic training on how to use computer in a healthier way
Control - Current practices
Category
Lifestyle
2
Description
The control group was given a basic occupational health talk
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Malaya
Full name of responsible person
Mr Hishamuddin
Street address
Occupational Safety and Health Unit, University of Malaya
City
Lembah Pantai
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Malaya
Full name of responsible person
University of Malaya
Street address
University of Malaya
City
Lembah Pantai
Grant name
Grant code / Reference number
PG127-2014A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Malaya
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Full name of responsible person
Dr Muhamad Hazizi Bin Muhamad Hasani
Position
Main researcher
Other areas of specialty/work
Street address
University of Malaya
City
Lembah Pantai
Province
Kuala Lumpur
Postal code
59100
Phone
00
Fax
Email
muhamadhazizi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Full name of responsible person
Dr Muhamad Hazizi Bin Muhamad Hasani
Position
Main Researcher
Other areas of specialty/work
Street address
University of Malaya
City
Lembah Pantai
Province
Lembah Pantai
Postal code
59100
Phone
003139364
Fax
Email
muhamadhazizi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya
Full name of responsible person
Dr Muhamad Hazizi Bin Muhamad Hasani
Position
Main researcher
Other areas of specialty/work
Street address
University of Malaya
City
Lembah Pantai
Province
Kuala Lumpur
Postal code
59100
Phone
00
Fax
Email
muhamadhazizi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)