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CTRI Number  CTRI/2021/08/035883 [Registered on: 24/08/2021] Trial Registered Prospectively
Last Modified On: 25/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ergonomic Intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of ergonomic intervention among the bankers suffering from low back pain. 
Scientific Title of Study   Effectiveness of Ergonomic Intervention among the Bankers suffering from Low Back Pain. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zahid Bin Sultan Nahid 
Designation  Clinical Physiotherapist 
Affiliation  BRB Hospitals Ltd. 
Address  BRB Hospitals Ltd. 77/A, East Razabazar, West Panthapath. Dhaka-1215.
Village: Bhatpara, Post office: Paghachang, Police station: Brahmanbaria, District: Brahmanbaria


1215
Other 
Phone  1717704776  
Fax    
Email  ranacrpphysio@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Zahid Bin Sultan Nahid 
Designation  Clinical Physiotherapist 
Affiliation  BRB Hospitals Ltd. 
Address  BRB Hospitals Ltd. 77/A, East Razabazar, West Panthapath. Dhaka-1215.
Village: Bhatpara, Post office: Paghachang, Police station: Brahmanbaria, District: Brahmanbaria


1215
Other 
Phone  1717704776  
Fax    
Email  ranacrpphysio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Md. Feroz Kabir (Guide of Post-graduation thesis)) 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology (JUST) 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore Sadar, Bangladesh.



7408
Other 
Phone  1765932545  
Fax    
Email  physioferoz@gmail.com  
 
Source of Monetary or Material Support  
Bangladesh Open University (BOU) 
 
Primary Sponsor  
Name  Zahid Bin Sultan Nahid 
Address  BRB hospitals ltd, 77/A East Razabazar, Dhaka-1215 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Bijoy Das  BRB hospitals ltd, 77/A East Razabazar, Dhaka-1215 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bijoy Das  Head office of Mercantile Bank limited.   Room no: 501, Human Resource Division, Room No. 402 General Servicing Division, Room no: 404, General Banking Division, Room no: 301, Credit Risk management Division, Room no: 302, Public Relation Division, room no 203, mobile Banking Division, 61 Dilkusha Commercial Area, Dhaka 1000, Bangladesh.

 		 1709635869

dr.bjoy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Review Board (IRB) of Institute of Physiotherapy Rehabilitation and Research (the academic institute of BPA)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ergonomic Intervention  1.Education regarding normal siting posture (Try to maintain this posture during work for 02 weeks) 2.Correction of the arrangement of work station: (Adjust monitor height and distance, Adjust Chair height), Should maintain this modification during work for two weeks. 3. Workplace exercises: •Stretching of Calf, hamstrings and back muscles (3 repeatition with 30 seconds hold twice during work for 02 weeks). •Back extension exercises in standing (5 repetition and thrice during work for 02 weeks) •Hourly change posture: Sit to stand (Once hourly for 30 seconds during work for 02 weeks).  
Comparator Agent  No treatment  No treatment 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Bankers who are suffering from LBP and doing job regularly.
2. Age between 30 to 55 years.
3. Male and female both are included.
4. Those who were motivated and given consent to include in the study.
 
 
ExclusionCriteria 
Details  1. Patients with clinical disorders where Ergonomic Intervention is contraindicated.
2. Diagnosed of secondary complications such as fever, weight loss, tumour, TB spine, fracture, dislocation, severe osteoporosis, and Paget‘s disease.
3. Rheumatoid Arthritis, Ankylosing Spondylitis, Cauda-equina lesions, Cord signs and Syndrome, Transverse myelitis and all sorts of infection.
4. LBP patients currently taking medication or any other treatment method.
5. Pregnant women.
6. Medically unstable, mental retardation and unwillingness to participate in the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome Name: Pain on 10 cm VAS score (Score 0 represents no pain and score 10 reprecents highest pain)  Two weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome name: Oswestry Disability Index in percentage (0 perecnt reprents no disability where 100% represents highest disability.  Two weeks. 
Health related Quality of life by Sf-12 questionnaire in percentage (Lower percentage represents low health related quality of life and high score represents high level of Quality of life).  Two weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/09/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   None yet 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be provided through email if required. Email: ranacrpphysio@gmail.com

  6. For how long will this data be available start date provided 07-07-2022 and end date provided 06-07-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, parallel group clinical trial that  will evaluate the effectiveness of Ergonomic Intervention for two weeks among the Bankers with low back pain that will be conducted on two branches of a Bank of Dhaka, Bangladesh. Ergonomic intervention will be applied on Experimental group and no intervention will be given to control group. Outcome will be measure after two weeks of intervention. The primary outcome measure will be Pain on 10 cm VAS score at two weeks. The secondary outcome will be Oswestry Disability index in percentage and health related quality of life by SF-12 score in percentage at two weeks.  
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