FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062318 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 04/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparing Shockwave and Therapeutic Ultrasound Treatments for Knee Osteoarthritis: What Helps with Pain, Movement, and Strength 
Scientific Title of Study   Effect of Radial Extracorporeal Shockwave Therapy v/s Therapeutic Ultrasound on pain, physical function and strength in patients with Knee Osteoarthritis: An Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Niraj Khandelwal 
Designation  Master of Physiotherapy Student 
Affiliation  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  8208301776  
Fax    
Email  niraj.k@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Annamma Varghese 
Designation  HOD, Musculoskeletal Physiotherapy 
Affiliation  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  9223402046  
Fax    
Email  annamma@somaiya.edu  
 
Details of Contact Person
Public Query  
Name  Dr Annamma Varghese 
Designation  HOD, Musculoskeletal Physiotherapy 
Affiliation  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai Mumbai MAHARASHTRA 400022 India

Mumbai
MAHARASHTRA
400022
India 
Phone  9223402046  
Fax    
Email  annamma@somaiya.edu  
 
Source of Monetary or Material Support  
OPD 4, KJ Somaiya college of physiotherapy 
 
Primary Sponsor  
Name  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya College of Physiotherapy Eastern express highway Sion Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niraj Khandelwal  KJ Somaiya college of physiotherapy  OPD 4 Musculoskeletal Department KJ Somaiya college of physiotherapy Estern express highway Sion Mumbai
Mumbai
MAHARASHTRA 		 8208301776

niraj.k@somaiya.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instutional Ethics Committee KJ Somaiya College of Physiotherapy  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 
Intervention  Radial Extracorporeal Shockwave Therapy  Aqueous gel will be applied to the skin before administering the shockwave to the knee joint. The shockwave probe will be applied directly to the most tender areas of the medial tibial plateau and the patellofemoral border. During each treatment session, a total of 2000 shocks will be delivered, with 1000 shocks specifically targeted at the medial tibial plateau and 1000 shocks focused on the patellofemoral border. These pulses will be administered at a frequency of 5 Hz and air pressure used for the treatment will be set at 3.0 Bar 
Comparator Agent  Theraputic Ultrasound   The ultrasound probe will be applied using an aqueous gel as a coupling medium in circular movements with the probe positioned at right angles to the skin. The treatment area will cover a total of 25cm2 and will extend to both the patellofemoral and tibiofemoral borders of the target knee on both the lateral and medial margins, while avoiding the patella. Continuous ultrasonic waves will be applied with a frequency of 1 MHz and a power of 1 watt/cm2 for 5 minutes, during which the ultrasound waves will be consistently delivered to the targeted knee area. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between 40 to 60 years of age, diagnosed with osteoarthritis of the knee with a Kellgren-Lawrence grading of II or III, having unilateral knee osteoarthritis or more severe symptoms in one knee of bilateral osteoarthritis, experiencing pain in the knee joint with a visual analog scale (VAS) score ranging from 4 to 7, and willing to participate in the study. 
 
ExclusionCriteria 
Details  1)Previous knee surgery (in last 2 years).
2)Knee joint infection.
3)Metal implants.
4)Rheumatoid arthritis or other inflammatory joint diseases.
5)Knee joint instability or ligamentous injury. 6)Contraindication to Shock wave therapy or Therapeutic ultrasound.
7)Any other medical or psychological condition that may interfere with the study procedures or outcome. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Visual analogue scale
2)Western Ontario and McMaster University Osteoarthritis Scale
3)Humac NORM Isokinetic Dynamometer 		 Pre intervention:Baseline assessment
Post intervention:After 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/02/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Approval is obtained from Institutional Ethics Committee. Patients will be selected based on inclusion criteria. Written Informed Consent will be taken from patients and basic demographic data will be collected. Pre-treatment assessment will be done for pain using  Visual Analogue Scale (VAS),  for physical function using  WOMAC scale and  strength using  isokinetic dynamometer. 
Patients will be allocated randomly using computer based software into Group A or Group B. Group A – Radial Extracorporeal Shockwave therapy+ Exercise for 3 weeks. Group B -Therapeutic ultrasound+ Exercises for 3 weeks. Post treatment Assessment will be done after 3 weeks  for pain using Visual Analogue Scale (VAS),  for physical function using WOMAC scale and  strength using  isokinetic.Statistical analysis will be done after data collection.
 
Close