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CTRI Number  CTRI/2025/11/097165 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Platelet-Rich Plasma Combined with Strengthening Exercise in Knee Osteoarthritis 
Scientific Title of Study   Effect of Platelet-Rich Plasma Combined with Supervised Strengthening Exercise on Pain in Knee Osteoarthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sree Pallob  
Designation  Undergraduate Student 
Affiliation  Jashore University of Science and Technology 
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
Jashore 7408, Bangladesh


7408
Other 
Phone  01853564729  
Fax    
Email  pallobbiswasbiswas@gmail.com  
 
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  01670962775  
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  01670962775  
Fax    
Email  mz.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
Physiotherapy and Rehabilitation Department, Jashore University of Science and Technology, Jashore, Bangladesh 
 
Primary Sponsor  
Name  Sree Pallob  
Address  Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore 7408, Bangladesh 
Type of Sponsor  Other [self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
Jashore University of Science and Technology Jashore Bangladesh  Jashore 7408, Bangladesh 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kazi Md Azman Hossain  M.R Khan Medical Center  301 no room, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore 7408, Bangladesh

 		 01660140833

azmanhossain51@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (IRB) of the Department of Physiotherapy & Rehabilitation at Jashore University of Science & Technology   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group: Supervised Strengthening Exercise Program  The Supervised Strengthening Exercise Program will be conducted over a duration of 8 weeks, with 3 sessions per week. Each session will last for 60 minutes, including a 10-minute warm-up consisting of light walking, marching, and joint mobility exercises. The strengthening exercises will be performed for 40 minutes and will include exercises using a TheraBand: knee flexion-extension, terminal knee extension, leg press, calf raise, and mini-squats. The exercises will progress through three stages: Stage 1 (Yellow band) for 3 sets of 10 repetitions, Stage 2 (Red band) for 3 sets of 15 repetitions, and Stage 3 (Green band) for 3 sets of 20 repetitions. A cool-down of 10 minutes will follow, consisting of light stretching of the hip flexors, outer hip, quadriceps, and hamstrings, with each stretch held for 15 seconds and repeated 3-5 times. During each session, there will be 15 seconds of rest between sets and 1 minute of rest between different exercises. The program will be divided into three stages: Stage 1 (Sessions 1 to 8), Stage 2 (Sessions 9 to 16), and Stage 3 (Sessions 17 to 24), with the intensity and resistance progressing as tolerated by the patient. 
Intervention  Experimental group: Platelet-Rich Plasma + Supervised Strengthening Exercise Program  Participants in this group will receive three intra-articular PRP injections at weekly intervals (Week 0, Week 1, and Week 2). For each session, 32 mL of peripheral venous blood will be drawn aseptically from the antecubital vein using atraumatic techniques to prevent platelet damage. The collected blood will be distributed into eight sterile tubes (4.5 mL each) containing 3.2% sodium citrate as an anticoagulant. The tubes will then be centrifuged once for 10 minutes at 1800 rpm, resulting in three layers: plasma (top), platelet and leukocyte “buffy coat” (middle), and erythrocytes (bottom). Approximately 4 mL of blood will remain after centrifugation, consisting of 2 mL plasma, 0.2 mL buffy coat, and 1.8 mL erythrocytes. To standardize preparation, the entire 0.2 mL buffy coat and the upper 0.8 mL platelet-rich plasma will be collected using a modified Anitua method, while the remaining plasma and erythrocyte layers will be discarded. The combined portion from all tubes will yield approximately 8 mL of PRP, which will be transferred into sterile syringes covered with black tape to protect from light. The prepared PRP will be administered intra-articularly through the anterolateral and inferior portals under aseptic conditions immediately after preparation. The Supervised Strengthening Exercise Program will be conducted over a duration of 8 weeks, with 3 sessions per week. Each session will last for 60 minutes, including a 10-minute warm-up consisting of light walking, marching, and joint mobility exercises. The strengthening exercises will be performed for 40 minutes and will include exercises using a TheraBand: knee flexion-extension, terminal knee extension, leg press, calf raise, and mini-squats. The exercises will progress through three stages: Stage 1 (Yellow band) for 3 sets of 10 repetitions, Stage 2 (Red band) for 3 sets of 15 repetitions, and Stage 3 (Green band) for 3 sets of 20 repetitions. A cool-down of 10 minutes will follow, consisting of light stretching of the hip flexors, outer hip, quadriceps, and hamstrings, with each stretch held for 15 seconds and repeated 3-5 times. During each session, there will be 15 seconds of rest between sets and 1 minute of rest between different exercises. The program will be divided into three stages: Stage 1 (Sessions 1 to 8), Stage 2 (Sessions 9 to 16), and Stage 3 (Sessions 17 to 24), with the intensity and resistance progressing as tolerated by the patient. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Participants aged fifty years or older with a clinical diagnosis of knee osteoarthritis for at least six months according to the American College of Rheumatology criteria will be included. Eligible individuals must report an average knee pain score of four or higher on an eleven-point numerical rating scale over the past week and show mild to moderate radiographic tibiofemoral osteoarthritis defined as Kellgren and Lawrence grade two or three. All participants must provide informed consent and agree to participate in the eight-week study intervention. 
 
ExclusionCriteria 
Details  Participants will be excluded if they show greater lateral than medial joint space narrowing on radiographs. Other exclusion criteria include the presence of systemic or inflammatory diseases, a history of glucocorticoid injection within the past three months, hyaluronic acid injection within the past six months, previous treatment with autologous blood products or stem cell therapy, platelet count one hundred fifty thousand per microliter or lower, bleeding disorders, or ongoing anticoagulant therapy. For bilateral knee osteoarthritis, only the most symptomatic knee will be treated. 
 
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 
Measure pain using the Numeric Pain Rating Scale (NPRS)  At baseline, 8 weeks and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
functional performance using the WOMAC index, range of motion by Goniometer, measure lower limb muscle strength through Hand held digital dynamometer and functional mobility with the Timed Up and Go (TUG).  At baseline, 8 weeks and 6 months 
 
Target Sample Size   Total Sample Size="120"
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)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
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  

This randomized controlled trial investigates the effect of Platelet-Rich Plasma (PRP) combined with a supervised strengthening exercise program on pain and functional outcomes in knee osteoarthritis (OA). The experimental group will receive three intra-articular PRP injections and participate in an 8-week supervised exercise program. The control group will only undergo the exercise program. Primary and secondary outcomes will include pain intensity (Numeric Pain Rating Scale), functional performance (WOMAC), range of motion, muscle strength (digital dynamometer), and functional mobility (Timed Up and Go). Inclusion criteria involve individuals aged 50+ with mild to moderate knee OA.

 
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