FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077033 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of a multidimensional intervention program on work-related Musculoskeletal symptoms among IT professionals in selected companies; Bangalore 
Scientific Title of Study   A study to assess the Effectiveness of Multidimensional intervention Intervention program on work-related Musculoskeletal symptoms among IT professionals in selected companies Bangalore 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  saranyas 
Designation  Asst professor/ Ph.D. scholar 
Affiliation  Chettinad Academy and Research Institution 
Address  Room No. 1: Chettinad Academy of Research and Education, Chettinad Health city, Rajiv Gandhi salai, OMR, Kelembakkam, Tamil Nadu, India Department: Medical-surgical nursing.
-
Chennai
TAMIL NADU
603103
India 
Phone  9620115345  
Fax    
Email  sara.ramnt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Mayilananthi 
Designation  Professor 
Affiliation  Chettinad Academy & Research Institution 
Address  Room No. 1: Chettinad Academy of Research and Education, Chettinad Health city, Rajiv Gandhi salai, OMR, Kelembakkam, Tamil Nadu, India Department Medical-surgical nursing

Chennai
TAMIL NADU
603103
India 
Phone  9620115345  
Fax    
Email  ananthisuhaa@gmail.com  
 
Details of Contact Person
Public Query  
Name  saranyas 
Designation  Asst professor/ Ph.D. scholar 
Affiliation  Chettinad Academy and Research Institution 
Address  Room No.1: Chettinad Academy of Research and Education, Chettinad Health city, Rajiv Gandhi salai, OMR, Kelembakkam, Tamil Nadu, India Department: Medical-surgical nursing

Chennai
TAMIL NADU
603103
India 
Phone  9620115345  
Fax    
Email  sara.ramnt@gmail.com  
 
Source of Monetary or Material Support  
Room No. 1, Chetinad Academy of Research and Education, Rajiv Gandhi Salai, OMR, Kelembakkam, Tamil Nadu, India, 603103 
 
Primary Sponsor  
Name  saranyaS 
Address  Room No. 1: Chettinad Academy of Research and Education, Chettinad Health city, Rajiv Gandhi salai, OMR, Kelembakkam, Tamil Nadu, India pin- 603103  
Type of Sponsor  Other [self] 
 
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 
MrAmal Raj  NIXSERV IT SOLUTIONS PVT LTD  Room No. 1, E-1 MSM Plaza, 4th floor, Outer Ring Road, Horamavu Service Lane, near Banaswadi Junction, Bangalore. pin-560043
Bangalore
KARNATAKA 		 9739998122

amalrajnixserv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee for Student Research (CARE IHEC -I )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multidimensional interventional program  Experimental group, There are sixty participants. It will be split into three groups, with twenty people in each group. First intervention: Education regarding WRMS; after pretest, Patient immediately undergoes this session (duration: 30 minutes) Education regarding WRMS through a PowerPoint presentation- includes definitions, causes, risk factors, signs and symptoms, and management prevention Life style modification This involves figuring out how many hours one works at an office and at home, and also the mode of transportation (car, bike, and number of hours spent traveling). The researcher will assess this and offer recommendations for changes. second intervention is ergonomic modification (5mts) It contained the modification of the chair height and working desk, the sitting posture, the distance and level between the eyes and the monitor based on recommendations from the rapid office strain assessment. Third intervention: 10 minutes/3 days/week Exercise routine contained certain validated and standardized office-based stretching exercises for office employers in response to shoulders, lower back, and neck pains. The exercise protocol contained seventeen exercises. Upper limb exercise: neck stretch, Tilt head From Front To Back. Neck protraction , Chin Tuck, Cross-Chest Stretch, Shoulder Shrugs, Wrist Extensor and flexor Stretch, Wrist Radial Ulnar Deviation. Finger Flexion Extension, Pectoralis Major Stretch, Side stretching. Lower limb exercise: midback stretch, Standing Quadriceps Stretch, Hip Adductors Stretch, Gluteal Muscles Stretch, dorsiflexion stretch, etc. Total duration of program: 6 month  
Comparator Agent  placebo control  Education on WRMS Duration: 30 minutes There will be sixty participants in the control group. The control group will be split up collectively. There will be 20 people in each group. Using a PowerPoint presentation, the researcher will instruct participants in the WRMS, including definition, causes, risk factor management, and prevention of WRMS. Duration: 30 minutes per group Program duration: 1 hour and 30 minutes. Each control group will receive education regarding WRMS half an hour after pretest.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Working more than 4hours /Day, 20hours/week
Working for more than 2 years in the field of the software profession
Who has any two symptoms from extended Nordic musculoskeletal questionnaire?
 
 
ExclusionCriteria 
Details  Subjects who have musculoskeletal problems because of pre-morbid conditions like accident
The subject has a history of trauma, neurological involvement, spinal fracture, spinal surgery
Subjects suffering from degenerative and inflammatory diseases like osteoarthritis, Rheumatoid arthritis
BMI above 30 kg/m
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
promote ergonomic factors, prevent musculoskeltal discomfort
 
8 weeks-12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
prevent of long term disability promote quality of life  5-10years 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/12/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  results

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  nil
  3. Who will be able to view these files?
    Response (Others) -  researcher

  4. For what types of analyses will this data be available?
    Response (Others) -  nil

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 13-09-2024 and end date provided 13-07-2030?
    Response (Others) -  nil

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   work related musculoskeletal disorder is defined as a widespread  inflammatory and degenerative disease condition that results in pain and functional loss disturbuting the body part especially shoulder,neck,hands and lower back.
 AIm: to identify the prevalence and ergonomic risk factors, create awareness through a multidimensional program.
Methodology; quantitative approach, true experimental design; pretest post-test control group design.
Population IT professionals who work in chipware technology between the ages of 25 and 40 years .subject will be assigned randomly to experimental (60) and control group(60)
Tool: Extended Nordic scale for identify the prevalence, ROSA scale to detect ergonomic risk factors , bishop and corlette disability scale to identify the musculoskeletal disability.
Data collection and a pre-test will be done, followed by the administration of the intervention on WRMS for 6 months with the reinforcement. the post-test will be after 3rd and 6th month
 
Close