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CTRI Number  CTRI/2025/08/092943 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two treatments to reduce long-term knee pain in arthritis patients – nerve blockade by ablation vs steroid injection using ultrasound guidance  
Scientific Title of Study   Comparative study to assess the analgesic efficacy of Cooled Radio Frequency Ablation of genicular nerve and Intra Articular CorticoSteroids, under ultrasound guidance for chronic knee pain from Osteoarthritis knee. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  V Vaishnavi  
Designation  Junior resident- Anaesthesia PG 
Affiliation   
Address  Department of Anaesthesiology New modular OT 1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL KK NAGAR, CHENNAI 600078

Chennai
TAMIL NADU
600078
India 
Phone  9789993988  
Fax    
Email  vaishu.8492@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  V Vaishnavi  
Designation  Junior resident- Anaesthesia PG 
Affiliation   
Address  Department of Anaesthesiology New modular OT 1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL KK NAGAR, CHENNAI 600078

Chennai
TAMIL NADU
600078
India 
Phone  9789993988  
Fax    
Email  vaishu.8492@gmail.com  
 
Details of Contact Person
Public Query
 
Name  V Vaishnavi  
Designation  Junior resident- Anaesthesia PG 
Affiliation   
Address  Department of Anaesthesiology New modular OT 1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL KK NAGAR, CHENNAI 600078

Chennai
TAMIL NADU
600078
India 
Phone  9789993988  
Fax    
Email  vaishu.8492@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College and Hospital,Ashok pillar main road,Kk nagar,Chennai 600078 
 
Primary Sponsor  
Name  ESI medical college and hospital 
Address  Ashok pillar road, Kk nagar, Chennai 600078 
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 Ilango Ganesan  ESI Medical College and Hospital  Department of Anaesthesiology New modular OT 1st floor, B block, ESIC MEDICAL COLLEGE AND HOSPITAL KK NAGAR, CHENNAI 600078
Chennai
TAMIL NADU 
9884149429

gilang@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intra articular steroids  Intra articular corticosteroids to treat OA knee pain 
Intervention  Radio frequency ablation   Cooled radio frequency ablation of genicular nerves to treat OA knee pain 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients diagnosed with ACOR criteria with radiological evidence but not willing for surgery  
 
ExclusionCriteria 
Details  Patient refusal, bleeding diathesis, previous Intra articular injection in last 3 months, previous knee surgeries, rheumatoid arthritis, ligament injuries  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare analgesic efficacy of cooled RFA of genicular nerve and Intra articular cortico steroids under ultrasound guidance for chronic knee pain in OA knee  Time point of pain assessment pre procedure, immediately after procedure, 24 hrs, 1 week, 2 week and 4 week interval 
 
Secondary Outcome  
Outcome  TimePoints 
To assess improvement of knee function  Assessed using WOMAC score 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/08/2025 
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="0"
Months="6"
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  

Osteoarthritis (OA) is one of the most common degenerative disorders among the elderly population. Around 23.46 million individuals in India had OA in 1990; this increased to 62.35 million in 2019. DALY (Disability Adjusted Life Years) due to OA increased from 0.79 million to 2.12 million. OA was the 20th most common cause of YLDs ( Years Lived in Disability) in India in 2019, accounting for 1.48%  of all YLDs; increasing from 23rd most common cause in 1990 . Knee OA was the most common form of OA, followed by hand OA. The prevalence, incidence, and DALYs for OA and knee OA were consistently higher in females than male [1].

 

The current treatment of OA knee consists of conservative management such as exercise, physical therapy, pharmacological agents such as NSAIDS. Intake of analgesics to alleviate pain will cause renal damage, gastritis, peptic ulcers etc. When the conservative management fails to relieve pain, non surgical procedures like Intra Articular Injection of Cortico Steroids[2], Hyaluronic Acid [3][4], Platelet Rich Plasma [5] is widely used.The definitive treatment for OA knee is total Knee replacement surgery.

 

  

Intra Articular CorticoSteroids is one of the most commonly used minimally invasive OPD ( Out Patient Department) procedure where a corticosteroid drug is injected into intra articular space to alleviate pain. IACS decreases joint inflammation there by decreasing the pain for a short duration ( wks to months). 

         The radio frequency ablation is a new treatment methadology for chronic degenerative knee pain. The goal of cooled radio frequency ablation (CRFA) of genicular nerve is to alleviate the knee pain and improve the function and the quality of life of patients with OA knee. It is also a OPD procedure , done without any incision, recovery time is short and the patient can get back soon to their normal day to day activities. Under ultrasound guidance, RF needles will be inserted near the targeted nerves and a gentle electric current  ( cooled)  is passed through it to ablate the nerve. Cooled RFA is better than conventional RFA, as it targets a wider region and chance of ablating the nerve is high. As per previously published articles, the pain relief after RFA procedure may last for 6 month to 1 years duration. Nerves start to regenerate after 6 months and the procedure will provide control over pain long enough for rehabilitation.

 

Both the procedures are well tolerated in office setting under local anaesthesia or done in operating room under conscious sedation using a low dose sedative such as midazolam for anxious patients.

 
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