| 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
|
|
|
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
|
|
|
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 |
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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. |