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CTRI Number  CTRI/2025/07/092001 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intra-articular injection (Triamcinolone Acetonide)]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on injection and exercise for knee joint pain 
Scientific Title of Study   Effectiveness of Intra-articular Injection with Strengthening Exercise versus Conventional Physiotherapy in Knee Osteoarthritis Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunjana Saima Anesha 
Designation  Undergraduate Student 
Affiliation  Jashore University of Science and Technology 
Address  Room: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801789118985  
Fax    
Email  mz.hossain@just.edu.bd  
 
Details of Contact Person
Scientific Query  
Name  Dr Md Zahid Hossain 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology 
Address  Room: 307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801670962775  
Fax    
Email  mz.hossain@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Md Zahid Hossain 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology 
Address  Room: 307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801670962775  
Fax    
Email  mz.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Level 2 and 3, Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh 
 
Primary Sponsor  
Name  Dr Ehsanur Rahman Department of Physiotherapy and Rehabilitation 
Address  Room: 403, Jashore University of Science and Technology, Jashore-7408, Bangladesh 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Kabir Hossain  Dr. M R Khan Medical Center  Jashore University of Science and Technology, Room: 301

 		 8801778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy and Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Warm up-10 min, strengthening exercise-20 min, balance and stability exercise-10 min, lower limb stretching exercise-5 min, cool down exercise-5 min (8 week, 3 session per week) 
Intervention  Intra-articular injection with strengthening exercise  1st dose intra-articular injection, if pain abolish then no need further intra-articular injection. Pain still then 2nd dosages after 4 weeks, pain still present last dose after 4 weeks, after complete dose 7 days rest then will be started 8 weeks (3 session per week) quadriceps and hamstring strengthening exercise 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The inclusion criteria considered patients aged 40-70 years with knee osteoarthritis confirmed by a rheumatologist (grades I-III in the Kellgren-Lawrence score) who had pain, morning stiffness of shorter than 30 minutes, or knee crepitus. 
 
ExclusionCriteria 
Details  Contraindication for IA injection such as overlying skin and soft tissue infection, uncontrolled bleeding diathesis, IA glucocorticoid injection in the past 3 months, patients with secondary OA due to inflammatory arthritis, trauma or infection or history of knee replacement in the same joint and planning for knee surgery within 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain by Numeric Pain Rating Scale  8 weeks intervention, a follow up will be conducted after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Physical function by Western Ontario and MacMaster Universities Osteoarthritis Index, Range of motion by Standard Goniometer, Lower limb muscle strength by 30 second Sit-to-Stand Test, Functional mobility by Timed Up and Go test  8 weeks intervention, a follow up will be conducted after 6 months 
 
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   Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mz.hossain@just.edu.bd].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled trial compares the effectiveness of intra-articular corticosteroid injection plus strengthening exercise versus conventional physiotherapy in knee osteoarthritis patients aged 40–70 years. The intervention lasts 8 weeks, with injections given based on pain levels. Primary outcome is pain measured by NPRS, and secondary outcomes include WOMAC, TUG test, goniometer, 30 second Sit-to-Stand test. Follow-up will be done at 6 months to assess long-term effects. 
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