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CTRI Number  CTRI/2025/07/090674 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on Shockwave Therapy for Front Knee Pain 
Scientific Title of Study   Effectiveness of Extracorporeal Shockwave Therapy on Pain and Morphological Characteristics of Patellofemoral Pain Syndrome 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mubashsira Islam Raisa 
Designation  Undergraduate Student 
Affiliation  Jashore University of Science and Technology 
Address  Room No: 304 , Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801737860496  
Fax    
Email  mubashsiraraisa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology 
Address  Room No : 405, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd   
 
Details of Contact Person
Public Query
 
Name  Dr Kazi Md Amran Hossain 
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology 
Address  Room No : 405, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd   
 
Source of Monetary or Material Support  
Dr M R Khan Medical Centre ,Department of Physiotherapy, 3rd floor ,Jashore University of Science and Technology, Jashore-7408 
 
Primary Sponsor  
Name  Dr Ehsanur Rahman 
Address  Room No : 401 ,Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology 
Type of Sponsor  Other [Self] 
 
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 Centre  Level-3, Room :301, Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408

 
8801778315139

kabir2002pt@gmai.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB 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: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Extracorporeal Shockwave Therapy with Quadriceps Isometric Strengthening Exercise  Experimental group will receive on patellar tendon and quadriceps insertion in 8 sessions twice a week , each lasting 15 – 20 minutes for three weeks, with two days gap between sessions using the BTL-6000 Shockwave Therapy device. A total of 2000 pulses were delivered per session at a frequency of 10–15 Hz. The intensity was progressively increased from 0.2 to 0.5 BAR depending on patient tolerance. Receive Quadriceps Isometric Strengthening Exercise which conducted for 10s hold ,2 sets /15 repetitions, 2 min rest between sets. 
Comparator Agent  Ultrasound Therapy with Quadriceps Isometric Strengthening Exercise  Receive Ultrasound Therapy on patellar tendon and quadriceps insertion in 15 sessions every day ,each lasting 15 minutes for three weeks, using Mode : Pulse ; Pulse ratio : 1:1 ; Intensity : 0.8 – 1.0 watts/cm2 ; Frequency : 3MHz – 2.0 mm. Receive Quadriceps Isometric Strengthening Exercise which conducted for 10s hold ,2 sets /15 repetitions, 2 min rest between sets 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Men and women aged between 19 to 60 years.
Individuals with Patellofemoral Pain having a Kujala Score of less than 100.
Presence of any soft tissue lesion or tendinosis in the quadriceps tendon as noted in musculoskeletal ultrasonography (MSK USG).
Presence of any soft tissue lesion or tendinosis in the patellar tendon as noted in musculoskeletal ultrasonography (MSK USG).

Presence of patellofemoral degenerative changes as noted in musculoskeletal ultrasonography (MSK USG).

Able to walk independently without the use of walking aids 
 
ExclusionCriteria 
Details  Patients who contraindicated to ESWT such as pregnant, blood clotting disorders, oral anti coagulants, received steroid injections within 6 weeks, pacemaker fitted, tumor, fracture dislocation, history of tendon rupture (Enfield Osteopathic Field)
Individuals with Infrapatellar bursitis, fat pad impingement, patellar tendinopathy injuries, Osgood Schlatter syndrome. (Enfield Osteopathic Clinic)
History of surgery with past 6 months
Patients with neurological conditions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain which is measured by Pressure Algometer, Anterior Knee Pain Scale , Knee injury and Osteoarthritis Outcome Score - Patellofemoral subscale and Morphological Characteristics which is measured by Musculoskeletal Ultrasonography imaging  4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be Functional Activity which is measured by Lower Extremity Functional Scale  4 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)  26/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
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 [kma.hossain@just.edu.bd].

  6. For how long will this data be available start date provided 15-09-2025 and end date provided 01-02-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
The purpose of this single centered, participant and assessor blinded parallel group Randomized Clinical Trial is to examine the effectiveness of ESWT with isometric exercises against UST with isometric exercises to improve pain and morphological characteristics which are primary outcome that measures through Pressure Algometer or Anterior Knee Pain Scale and USG and functional activity which is secondary outcome that measures through Lower Extremity Functional Scale with the patient of Patellofemoral Pain Syndrome.
The expected result of this study will be the ESWT with isometric exercise will be effective for pain reducing and significant changes can be found in morphological characteristics.
 
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