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CTRI Number  CTRI/2025/02/079979 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Ergonomic Exercises to avoid Musculoskeletal Problems in labor worker 
Scientific Title of Study   Ergonomic Intervention for Preventing Musculoskeletal Disorders among Industrial Labor workers in Anand 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirav Vaghela 
Designation  Professor 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325

Anand
GUJARAT
388325
India 
Phone  9428647304  
Fax    
Email  niravpv@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Riya Patel 
Designation  MPT Student 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325

Anand
GUJARAT
388325
India 
Phone  9316311988  
Fax    
Email  riyap9179@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Riya Patel 
Designation  MPT Student 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325

Anand
GUJARAT
388325
India 
Phone  9316311988  
Fax    
Email  riyap9179@gmail.com  
 
Source of Monetary or Material Support  
Labor workers of GIDC-Gujarat Industrial Development Corporation Vidyanagar Anand Gujarat India 388120 
 
Primary Sponsor  
Name  Dr Riya Patel Self funded 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Nirav Vaghela  K M Patel Institute of Physiotherapy  Shree Krishna Hospital, K M patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India 388325
Anand
GUJARAT 
9428647304

niravpv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE 2 Bhaikaka University, Karamsad, Anand, Gujarat-388325 [DHR Reg. No. EC/NEW/INST/2021/592][OHRP Reg. No. IRB00014178]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physiotherapy Exercise  Data collection will involve GIDC labor workers, who will be informed about the studys purpose, duration, and benefits. Eligible participants meeting inclusion criteria and providing informed consent will be enrolled. Assessment will include the Nordic Musculoskeletal Questionnaire and SF-36 Quality of Life Questionnaire via one-on-one interviews. Workers with pre-existing musculoskeletal conditions or accident histories will be included. Ergonomic interventions in the form of a 4-week Home Exercise Program (HEP) will be provided, focusing on stretching and postural correction. Exercises will target the knee, lumbar, and cervical joints. Exercises for Knee Joint: ankle toe movement, static quadriceps, static hamstrings, straight leg raise, heel slide, VMO strengthening, hamstring stretch, static glutei, hip abduction, knee extension, knee flexion. Exercises for Lumbar Joint: calf stretch, hamstring stretch, piriformis stretch, single knee-to-chest, double knee-to-chest, bridging, static abdominal, static abductors, static adductors, curls-up, prone on elbows, prone on hands, cat and camel exs, trunk rotation, namaz stretch. Exercises for Cervical Joint: cervical flexion, cervical extension, cervical rotation, trapezius stretch, isometric exercise (all directions), scapular retraction, pectoralis stretch, shoulder girdle exercise. On the first day, exercises will be demonstrated and a diary maintained by participants and therapists. Follow-up will be conducted telephonically, and post-intervention evaluation will occur at the industry after 4 weeks. 
Intervention  Physiotherapy Exercise  Exercises for Knee Joint: ankle toe movement, static quadriceps, static hamstrings, straight leg raise, heel slide, VMO strengthening, hamstring stretch, static glutei, hip abduction, knee extension, knee flexion. Exercises for Lumbar Joint: calf stretch, hamstring stretch, piriformis stretch, single knee-to-chest, double knee-to-chest, bridging, static abdominal, static abductors, static adductors, curls-up, prone on elbows, prone on hands, cat and camel exs, trunk rotation, namaz stretch. Exercises for Cervical Joint: cervical flexion, cervical extension, cervical rotation, trapezius stretch, isometric exercise (all directions), scapular retraction, pectoralis stretch, shoulder girdle exercise.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Individuals who were employed for at least one year.
2. Working hours more than 9 hours in a day.
3. Individuals who were lifting maximum weight around 23 kg per day.
4. Individuals with age of 18-40 years. 
 
ExclusionCriteria 
Details  1. Individuals with any Orthopaedic limitations like fracture, degenerative changes.
2. Individuals with any neurological involvement. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Nordic Musculoskeletal Questionnaire  At baseline after enrollment of participants and post intervention at 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
SF-36 Questionnaire  At baseline after enrollment of participants & post-intervention at 4 weeks  
 
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)   15/02/2025 
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="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  
INTRODUCTION: Musculoskeletal disorders (MSDs) are a leading cause of occupational injury globally, affecting workers’ health and causing financial losses for individuals, organizations, and society. MSDs impact muscles, tendons, ligaments, joints, cartilage, and the nervous system, often caused by awkward postures, repetitive motions, heavy lifting, vibrations, and extreme temperatures. Developing nations face high MSD rates due to poor working conditions and lack of preventive programs. Over the past 12 months, more than 75% of respondents reported musculoskeletal issues in the lower back (86.7%), ankle/feet (86.7%), neck (86.0%), shoulders (85.3%), lower legs (85.0%), upper back (84.3%), and knees (77.3%). Moderate prevalence was observed in the thighs (73.7%), hips (66.0%), forearms (61.7%), wrists/hands (63.0%), and elbows (55.0%). Prevention is key to managing MSDs, with strategies including job rotation, work-rest cycles, and ergonomic interventions. Industrial ergonomics aims to align work environments with workers’ physical needs, reducing discomfort and injury risks. Proper workplace design, informed by workers’ body dimensions, minimizes fatigue and accidents while enhancing efficiency. Studies show high MSD prevalence, particularly in the lower back, neck, shoulders, and lower limbs, highlighting the urgent need for ergonomic solutions and effective workplace injury prevention programs.

Therefore, the need of study is to carry out ergonomic intervention which can help employees focus on their tasks by reducing physical strain and stress on the body. 

Methodology: The participants will be screened with the help of which will include all the criteria regarding the inclusion and exclusion of participants in study. All those who meet the criteria for the same will be enrolled in this study. Labor Workers with pre-existing health conditions or those who had experienced occupational or non-occupational accidents affecting the musculoskeletal system will be also include. The participants, who have shown interest voluntarily, will be selected and an informed consent will be taken for the same and after that Assessment will be taken. The Nordic musculoskeletal questionnaire which is addressing musculoskeletal issues in various body regions and SF-36 questionnaire which shows quality of life will be filled. The questionnaires will be completed through one-to-one interviews with the labor workers. According to that ergonomics intervention should be given to the workers for 4 weeks in form of HEP, which include stretching and postural correction advices.
 
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