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CTRI Number  CTRI/2024/07/070589 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Repetitive Peripheral Magnetic Stimulation Patients With Knee Osteoarthritis 
Scientific Title of Study   Comparison of Repetitive Peripheral Magnetic Stimulation (rPMS) and Sham-rPMS With supervised exercise on pain and function in Knee Osteoarthritis Patients –A Randomised Sham-Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhuripu 
Designation  Associate Professor 
Affiliation  Srinivas University 
Address  Institute of Physiotherapy, Musculoskeletal Department, Srinivas University, Mangalore, Karnataka, 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9446292852  
Fax    
Email  madhuripu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajasekar S 
Designation  Professor cum Dean 
Affiliation  Srinivas University 
Address  Institute of physiotherapy, Musculoskeletal department, Srinivas university, Mangalore, Karnataka, 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9448156719  
Fax    
Email  rajasekar@srinivasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Rajasekar S 
Designation  PRrofessor Cum Dean 
Affiliation  Srinivas University 
Address  Institute of physiotherapy, Musculoskeletal department, Srinivas university,Mangalore, Karnataka,575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9448156719  
Fax    
Email  rajasekar@srinivasuniversity.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Madhuripu p 
Address  Associate professor, Institute of physiotherapy, Musculoskeletal department, Srinivas university, Mangalore, Karnataka, 575001 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
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 Madhuripu p  INSTITUTE OF PHYSIOTHERAPY  Musculoskeletal department, Srinivas university, Mangalore, Karnataka, 575001
Dakshina Kannada
KARNATAKA 		 9446292852

madhuripu.cpt@srinivasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srinivas University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Repetitive Peripheral Magnetic Stimulation   An intermittent stimulation regimen consists of 10 seconds of activation at 20 Hz accompanied by 20 seconds of rest. Treatment will be given 3 days per week (18 session) 20 minutes. 
Comparator Agent  Sham-Repetitive Peripheral Magnetic Stimulation  The sham rPMS stimulation was performed using the same coil as rPMS, but at a position perpendicular to knee joint at the medial and lateral sides, using an intensity of 5% of the maximum output,Frequncy will be kept at 20 Hz . Treatment will be given 3 days per week (18 session) 20 minutes. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  Bilateral or unilateral OA
American college of rheumatology’ criteria for knee osteoarthritis:
Knee pain plus at least 3 of the following:
1.More than 50 years of age.
2.Stiffness in morning for minimum of 30 minutes .
3.Crepitus on active movements.
4.Tenderness over bone.
5.Bony enlargement.
6.Absence of palpable warmth
 
 
ExclusionCriteria 
Details  •History of any surgery around the knee joint
•History of any ligament or meniscus injury around the knee joint
•Severe physical disability ( unable to walk even with walking aid)
•Seizure or Neurological conditions
•Cardiovascular disorder
•Any contraindicating implants(metal implants, pacemakers, electrical devices)
•Systemic illness RA, SLE, AS
•Infection or open wound
•Major psychiatric illness
•Suspected Malignant tumour and thrombosis

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Knee Injury and Osteoarthritis Outcome Score(KOOS)  0,3,6,12,24 
 
Secondary Outcome  
Outcome  TimePoints 
TAMPA Scale of Kinesiophobia-11  0,3,6,12,24 
The Global Rating of Change   0,3,6 
Step Stair Test   0,3,6,12,24 
Knee flexion and extension ROM  0,3,6,12,24 
Dynamometry of Quadriceps  0,3,6,12,24 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   30/07/2024 
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="2"
Months="0"
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 study compare repitative peripharal magnetic stimulation(rPMS) along withsupervaised exercise and sham  repitative peripharal magnetic stimulation along with supervaised exercise to find out the efectieveness of  rPMS,a total number of 6 weeks treatment duration is taken ,and outcome assed are KOOS,tampa-11,ROM,9 stair step test, GROC,and muscle power by dynamometry.,data will be taken at 0 day, 3dr week ,6th week, 3 months and 6th month.(3dr amd 6th months follow up) 
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