| CTRI Number |
CTRI/2025/10/096137 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the pain relief from two radiofrequency nerve treatments-3nerve vs 5 nerve- in people with long term knee osteoarthritis |
|
Scientific Title of Study
|
Comparison of the efficacy of 3 point versus 5 point genicular nerve radiofrequency ablation in patients with chronic knee osteoarthritis: A randomized control 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 |
Ganesh S Nath |
| Designation |
post graduate |
| Affiliation |
lady Hardinge Medical college |
| Address |
Dept of Anaesthesia
Academic Block
Lady Hardinge Medical college
Shaheen Bhagat singh road
Connaught place
Department of Anaesthesia
Academic Block
New Delhi
DELHI
110001
India |
| Phone |
9037556074 |
| Fax |
|
| Email |
ganeshhardy619@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Hayaran |
| Designation |
Director Professor |
| Affiliation |
lady Hardinge Medical college |
| Address |
Department of Anaesthesia
Lady Hardinge Medical College and associated hospitals
Department of Anaesthesia
Central
DELHI
110001
India |
| Phone |
9873903603 |
| Fax |
|
| Email |
nhayaran97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh S Nath |
| Designation |
post graduate |
| Affiliation |
lady Hardinge Medical college |
| Address |
Department of Anaesthesia
Lady Hardinge Medical College and Assosiated Hospital
Connaught Place
Department of Anaesthesia
Central
DELHI
110001
India |
| Phone |
9037556074 |
| Fax |
|
| Email |
ganeshhardy619@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical college Shaheed Bhagat Singh Road, Diz Area, Connaught Place New Delhi - 110001 Delhi NCR, India |
|
|
Primary Sponsor
|
| Name |
lady hardinge medical college |
| Address |
Department of Anaesthesia
Lady hardinge medical college Shaheed Bhagat Singh Road, Diz Area, Connaught Place New Delhi - 110001 Delhi NCR, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ganesh S Nath |
Lady Hardinge Medical College |
Department of Anaesthesia , 5th floor Academic Block
Shaheed Bhagat Singh Marg
New Delhi
DELHI |
9037556074
ganeshhardy619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics comittee for human research LHMC and associated hospitals, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3 Nerve Radiofrequency Ablation |
Thermal lysis of Superolateral ,superomedial and Inferomedial genicular nerves using a thermal probe of 80 to 90 degree celcius for a duration of 90seconds on each nerve. Total duration of procedure lasting 15 to 20minutes |
| Intervention |
5 nerve Radiofrequency Ablation |
thermal lysis of the sensory nerves supplying the knee joint,using a probe of temperature 80-90 degree celcius for a duration of 90 seconds thereby disrupting pain signal transmission. Total duration of procedure can be of 15 to 20 minutes.Conventional targets and added infrapatellar branch of saphenous nerve and recurrent fibular nerve |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group of 40 to 75 years
2. Knee osteoarthritis confirmed by X ray (Kellgren-Lawrence grade 2-4) with pain for at least 3 months and pain intensity of 4 on Numerical Rating Scale (NRS) despite conservative management
3.Patients refusing surgery
4. Positive response to diagnostic genicular nerve block (more than 50 percent pain reduction)
|
|
| ExclusionCriteria |
| Details |
1. Previous knee surgery or knee joint replacement or traumatic knee injury
2. Inflammatory arthritis such as rheumatoid arthritis, gout and psoriatic arthritis
3. Patellofemoral osteoarthritis
4. Patients receiving any other invasive treatment for knee osteoarthritis during the study period
5, Prior radiofrequency treatment of the target knee
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of 3-point versus 5-point genicular nerve radiofrequency ablation in terms of functional improvement by Oxford Knee Score in patients with chronic knee osteoarthritis at three months post-procedure. |
1 week, 1 month and 3 months, months post-procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain reduction by Numerical Rating Scale at 1 week, 1 month, and 3 months post-procedure
2. Procedure-related adverse events and complications
|
1 week, 1 month and 3 months, months post-procedure |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/10/2025 |
| 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="1"
Months="3"
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
|
Knee osteoarthritis is a prevalent cause of chronic pain and disability, and many patients are unsuitable or unwilling for total knee arthroplasty. Radiofrequency ablation of genicular nerves offers a minimally invasive alternative for pain relief. However, the optimal number of target nerves remains unclear. The conventional 3-point RFA may not capture all pain-transmitting genicular branches, whereas the newer 5-point approach could potentially improve efficacy by addressing additional nerve targets. This study aims to provide high-quality comparative evidence on the functional and analgesic outcomes of both techniques, helping define a more effective and standardized RFA protocol for knee osteoarthritis management. This randomized controlled study will be conducted at the Department of Anaesthesiology, Lady Hardinge Medical College, New Delhi, from August 2025 to November 2026. Sixty patients aged 40–75 years with chronic knee osteoarthritis (Kellgren-Lawrence grade II–IV) unresponsive to conservative therapy and showing more than 50 percent pain relief after diagnostic genicular nerve block will be enrolled. Participants will be randomly allocated (block randomization) into two groups:
- Group T: 3-point genicular nerve radiofrequency ablation (RFA)
- Group F: 5-point genicular nerve RFA
All procedures will be performed under ultrasound guidance using standard monitoring. Each target nerve will be confirmed by sensory and motor stimulation before lesioning at 80°C for 90 seconds. Patients will be followed at 1 week, 1 month, and 3 months post-procedure to assess pain (Numerical Rating Scale) and function (Oxford Knee Score). Data will be analyzed using SPSS v23, with statistical significance set at p less than 0.05.
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