| CTRI Number |
CTRI/2025/01/079348 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [radiofrequency nerve ablation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain relief among patients of chronic knee pain after radiofrequency ablation of genicular nerves through two different techniques. |
|
Scientific Title of Study
|
Comparison of efficacy and safety of conventional vs cooled radiofrequency ablation of genicular nerves in chronic osteoarthritis knee pain :A Randomised 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 |
Dr Shilpa Sinha |
| Designation |
Junior Resident ,Department Of Anaesthesia |
| Affiliation |
Sardar Patel Medical College,Bikaner |
| Address |
Dept of Anaesthesia,Sardar Patel Medical College,Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
07023608168 |
| Fax |
|
| Email |
shipoosinha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd.Yunus Khilji |
| Designation |
Associate Professor ,Department Of Anaesthesia |
| Affiliation |
Sardar Patel Medical College,Bikaner |
| Address |
Department of Anaesthesiology,Sardar Patel Medical College,Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
8587858715 |
| Fax |
|
| Email |
mohammedyunus.khilji@nhs.net |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Sinha |
| Designation |
Junior Resident ,Department Of Anaesthesia |
| Affiliation |
Sardar Patel Medical College,and PBM hospital,Bikaner |
| Address |
Department of Anaesthesia, Sardar Patel Medical College
Bikaner(Rajasthan)
Bikaner
RAJASTHAN
334001
India |
| Phone |
07023608168 |
| Fax |
|
| Email |
shipoosinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Sardar Patel Medical
College,Bikaner(334001),Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical CollegeBikanerRajasthan |
| Address |
Department Of Anaesthesia, Sardar Patel Medical College,Bikaner ,334001,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 Shilpa Sinha |
Sardar Patel Medical College,Bikaner |
Department of Anaesthesiology ,Sardar Patel Medical College,Bikaner
Bikaner
RAJASTHAN |
7023608168
shipoosinha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTIUITIONAL ETHICS AND RESEARCH BOARD |
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 |
| Intervention |
conventional radiofrequency ablation |
conventional radiofrequency ablation of genicular nerves with temperature around 80 degree celcius to 90 degree celcius for 90 seconds |
| Comparator Agent |
cooled radiofrequency ablation |
cooled radiofrequency ablation of genicular nerves with temperature relatively cooler around 60 degree celcius |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
chronic knee pain with grade 3 or 4 osteoarthritis,ready to give consent |
|
| ExclusionCriteria |
| Details |
patients with active infections around knee
patients with bleeding disorders or on anticoagulants
patients with known allergy to RFA material
patients with psychological disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the reduction in pain intensity post procedure following the conventional and cooled radiofrequency groups |
at 1 day,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess and compare functional improvement and patient"s satisfaction between the two groups
to evaluate complications |
day 1,1 month ,3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
03/02/2025 |
| 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="8"
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
|
Chronic knee pain refractory to conventional treatment is very common in osteoarthritic grade 3 and 4 patients. Radiofrequency ablation of genicular nerves offer a very affordable ,easier and compliant alternative for patients not willing to surgery.
Our aim is to compare the outcomes of conventional vs cooled radiofrequency ablation of genicular nerves in patients of chronic nerve pain. |