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CTRI Number  CTRI/2020/05/025363 [Registered on: 26/05/2020] Trial Registered Prospectively
Last Modified On: 09/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Radio frequency ablation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of nerve ablation for pain on knee muscle strength in patients with osteoarthritis 
Scientific Title of Study   Effect of radiofrequency ablation of genicular nerves on the isokinetic muscle strength of knee joint in patients with osteoarthritis knee: A randomised double blind clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayathri Warrier 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9495496025  
Fax    
Email  gayathriwarrier13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jeetinder Kaur Makkar 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009510  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jeetinder Kaur Makkar 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh


CHANDIGARH
160012
India 
Phone  7087009510  
Fax    
Email  jeet1516@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Post Graduate Institute of Medical Education and Research, Chandigarh, 160012 
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 
Jeetinder kaur Makkar  Post Graduate institute for Medical Education and Research  Pain OT, Main OT complex, Level 4, Nehru hospital, Post Graduate Institute for Medical education and Research, Chandigarh
Chandigarh
CHANDIGARH 		 7087009510

jeet1516@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee  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  Patients randomised into the control arm will be taken up in the OT and under LA, RF cannulas will be placed in the approximate anatomical landmarks but the radio frequency ablation will not be carried out. The audio of the procedure being conducted will be played in the background to ensure blinding of the patient 
Intervention  radio frequency ablation to genicular nerves  radio frequency ablation will be delivered to superior medial genicular nerve, inferior medial genicular nerve and superior lateral genicular nerve under fluoroscopic guidance with ultrasound imaging for confirmation. a 10cm, 22G electrode with 10mm active tip will be used to deliver a temperature of 70 degree celsius for 90 seconds 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients having chronic knee osteoarthritis pain having VNRS > 50, KL grading of 2 or more, not responding to physiotherapy or oral analgesics 
 
ExclusionCriteria 
Details  patients with acute knee pain, history of trauma to the knees, prior knee surgery, connective tissue disorders, neurological or psychiatric disorders, received intraarticular injection with steroid or hyaluronic acid within 3 months, radicular leg pain, taking anticoagulant medications 
 
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 
Effects of Radiofrequency ablation of genicular nerves on isokinetic strength of knee joint  Baseline, 2 weeks, 1 month, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in VNRS of knee pain in response to radio frequency ablation  baseline, 2 weeks, 1 month and 3 months 
improvement in functionality assessed by WOMAC scale in response to radio frequency ablation  baseline, 2 weeks, 1 month, 3 months 
patient perception of effect as assessed by GPE scale  2 weeks, 1 month, 3 months 
Compliance to the suggested physiotherapy regimen assessed by a Likert scale  2 weeks, 1 month, 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/07/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A double blinded randomised clinical trial planned for assessing the effect of radio frequency ablation of genicular nerves on the isokinetic muscle strength of knee joint in patients with osteoarthritis knee. Patients with chronic pain from osteoarthritis knee not responding to oral analgesics or physiotherapy will be recruited into the trial. They will be randomised into either the intervention group or the control group based on computer generated random number envelopes.Baseline isokinetic muscle strength of knee, VNRS and WOMAC will be recorded for all patients.Patients belonging to the intervention group will receive thermal radio frequency ablation to SMGN, IMGN, SLGN. Patients in the control group will undergo a sham procedure wherein the radio frequency cannulas will be placed but no ablation will be delivered. Both groups will be followed up after 2 weeks, 1 month and 3 months of procedure. Isokinetic muscle strength, VNRS, WOMAC, Global perceived effects, Likert scale for compliance to physiotherapy will be assessed at each time point. Final data will be analysed to look for any improvement in muscle strength in patients who have received GNRF over those who did not.  
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