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CTRI Number  CTRI/2024/09/073280 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Behavioral
Other (Specify) [Ergonomic interventions]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Exercise program at workplace for Radiographers and test the influence on pain, muscle function, and quality of life. 
Scientific Title of Study   Effectiveness of a co-designed workplace based intervention on pain, muscle dysfunction, and quality of life among Radiographers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ULLAS U NAYAK 
Designation  PhD scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Division of Anatomy Department of Basic Medical Sciences, MAHE, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  8105099264  
Fax    
Email  ullasnayak98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Mohandas Rao KG 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Division of Anatomy, Department of Basic Medical Sciences, MAHE Manipal- 576104
. .
Udupi
KARNATAKA
576104
India 
Phone  9741988839  
Fax    
Email  mohandas.rao@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Sidhiprada Mohapatra 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy,MCHP,Manipal
. .
Udupi
KARNATAKA
576107
India 
Phone  8050730675  
Fax    
Email  sidhi.mohapatra@manipal.edu  
 
Source of Monetary or Material Support  
Division of Anatomy, DBMS, MAHE, Manipal-576104, Karnataka, India. 
 
Primary Sponsor  
Name  Ullas U Nayak 
Address  Division of Anatomy, DBMS, MAHE, Manipal-576104, Karnataka, India 
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 
Ullas U Nayak  Manipal Academy of Higher Education  Division of Anatomy, Department of Basic Medical Sciences, Room no. 316, 3rd floor, Division of Anatomy Department of Basic Medical Sciences, MMMC Building, MAHE, Manipal-576104
Udupi
KARNATAKA 
8105099264

ullasnayak98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College/Kasturba Hospital Institutional Ethical Committee (KMC/KH IEC)   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, (2) ICD-10 Condition: M998||Other biomechanical lesions, (3) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Co-designed workplace based intervention  Exercise, ergonomic changes, design intervention, postural correction, educational material. The intervention will be updated based on Phases 1 and 2 results. Intervention will be supervised intermittently 2-3 times per week. Intervention has to be performed daily at worksite. Adherence will be monitored.Total duration is 8 weeks 
Comparator Agent  Exercise program   Control will continue with their usual daily activity and the structured exercise program used conventionally will be advised to the group. For Control group, intervention will not be supervised however, participants will be advised to perform daily at worksite. Adherence will be monitored.Total duration is 8 weeks with reminders every 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  56.00 Year(s)
Gender  Both 
Details  1. Radiographers with Work-related musculoskeletal disorder with NPRS score ≥ 3.
2. Radiographers appointed as full-time employees
3. With more than one year of experience
4. Who pass the Physical Activity Readiness Questionnaire (PAR-Q)  
 
ExclusionCriteria 
Details  Supervisors, students, and managers working in Radiography departments. Radiographers who have any history of trauma, generalised inflammatory diseases or degenerative diseases or diagnosed neoplastic conditions or any active infection. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain: Numeric Rating Scale (NPRS) and Algometer for pressure pain threshold.

Body composition: Bioelectrical impedance analyzer (BIA).

Activities: Workplace Activity Limitations Scale.

Participation: Work Ability Index.

Quality of life: Work-Related Quality of Life Scale-2 (WRQoL-2). 
Baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Analgesic use and any therapy taken: Self-reported.
Muscle strength: Hand-held dynamometer for upper limb (shoulder flexors, abductors, elbow flexors) and lower limb (hip flexors, extensors, abductors, knee extensors), and Jamar dynamometer for grip strength.
 
Baseline and 8 weeks 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   03/09/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

Phase 1: Permission will be obtained from institutional ethics committee to conduct cross-sectional study to determine factors affecting work related musculoskeletal disorders among Radiographers. Sample size is 200. Based on the inclusion/ exclusion criteria participants will be enrolled. An informed consent will be taken. A questionnaire will be administered by researcher which will take 15-20 mins using Google Forms. Participants will be approached through the email ids received from hospital authorities, and social media contacts. Sample size for this is 200.

Phase 2: Focus group discussion (FGD) will be conducted with Radiographers and experts. Discussion will be moderated by Researcher with Physiotherapy background who will be accompanied by an assistant moderator a Phd Scholar from DBMS at Department of Basic Medical Sciences, MAHE. Focus group discussion will utilize a semi-structured interview guide with open-ended questions to explore needs and challenges at work practices,strategies obtained to prevent and manage WMSD and preferences for intervention components (e.g. exercise, education, information material, video clip, equipment adjustments).These FGD will last for 30-45 minutes, post FGD refreshments will be provided. Minimum of 2 FGD will be conducted and will be conducted till the point of saturation. The session will be audiotaped and transcribed.Thematic analysis will be done to identify key themes using inductive and deductive coding, insights, and suggestions from participants.

Delphi method: The focus group findings will be shared with experts and stakeholders using Delphi method.10 participants- Physiotherapist with background of Occupational health, Radiographer, Ergonomists, Clinical Psychologists, and Hospital administrators. Academicians and researchers with relevant expertise will be eligible.

Round 1: Experts and stakeholders will be asked to suggest intervention components based on the end-user needs and preferences and provide feedback on the feasibility, effectiveness, and sustainability of proposed components.

Expert and stakeholder suggestions will be summarized and categorized.

Round 2: The revised list of intervention components incorporating expert feedback from Round 1 will be shared with experts and stakeholders and will be asked to rate the importance and feasibility of each component on a 3 point Likert scale and provide further comments and suggestions for refinement.

Rounds will be repeated if necessary until 75 % of consensus is reached on the key components of the intervention program.

Phase 3: A cluster randomized trial will be conducted across 16 hospitals. The hospitals will be randomized to either the intervention or control group. Single stage- Cluster Randomised Controlled Trial using Computer generated random number table. 

For all the 16 hospitals permission will be sought. If the hospital authority specifies the need for Ethics committee approval from their hospital or associated institution, then IEC approval will be taken. Hospitals without an Ethics committee will be covered under the Institution Ethics Committee under Kasturba Hospital since these all are within 60kms of perimeter from Kasturba Hospital. 

Based on inclusion-exclusion criteria and informed consent will be obtained from 112 interested participants. Participants will be recruited from hospitals at their worksite. Individuals will be approached face-to-face for taking consent following which they will be recruited and there will be no travelling involved. The intervention group will receive an intervention program and control will continue with their usual daily activity. The intervention program will be implemented for eight weeks and will include a minimum of two supervised sessions. Outcome measures will be used to assess the program’s effectiveness for Pain-Numeric Rating Scale (NPRS) and Algometer for pressure pain threshold, Muscle strength- Hand-held dynamometer for upper limb (shoulder flexors, abductors, elbow flexors) and lower limb (hip flexors, extensors, abductors, knee extensors), and Jamar dynamometer for grip strength, Bioelectrical impedance analyzer (BIA), Workplace Activity Limitations Scale, Work Ability Index, Work-Related Quality of Life Scale-2 (WRQoL-2). Data will be collected at baseline and again ten weeks after the intervention.

If the intervention is effective, same intervention will be given to control group.

 
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