| CTRI Number |
CTRI/2019/04/018597 [Registered on: 15/04/2019] Trial Registered Prospectively |
| Last Modified On: |
25/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [radio frequency treatment ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods of radiofrequency treatment in Idiopathic Trigeminal Neuralgia |
|
Scientific Title of Study
|
Conventional Radiofrequency vs Pulsed Radiofrequency for the treatment of Idiopathic Trigeminal Neuralgia- A comparative Prospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anurag Agarwal |
| Designation |
Associate professor |
| Affiliation |
Dr. RMLIMS |
| Address |
Dr. Ram manohar lohia institute of medical sciences, Vibhuti khand, Gomti Nagar, Lucknow
Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007285 |
| Fax |
|
| Email |
dranurag11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anurag Agarwal |
| Designation |
Associate professor |
| Affiliation |
Dr. RMLIMS |
| Address |
Dr. Ram manohar lohia institute of medical sciences, Vibhuti khand, Gomti Nagar, Lucknow
Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007285 |
| Fax |
|
| Email |
dranurag11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjari bansal |
| Designation |
Junior resident |
| Affiliation |
Dr. RMLIMS |
| Address |
Dr. Ram manohar lohia institute of medical sciences, Vibhuti khand, Gomti Nagar, Lucknow
Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9027880255 |
| Fax |
|
| Email |
Mnjrbansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded, Dr Anurag agarwal Dr. RMLIMS,Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr RMLIMS |
| Address |
lucknow |
| 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 Anurag Agarwal |
Dr. RMLIMS, LUCKNOW |
Pain clinic, department of anesthesia
Lucknow
UTTAR PRADESH |
8176007285
dranurag11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicalCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G500||Trigeminal neuralgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CRF |
Conventional radiofrequency of Gasserian ganglion |
| Intervention |
PRF |
Pulsed Radiofrequency ablation of Gasserian Ganglion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
primary trigeminal neuralgia non responsive to medical management |
|
| ExclusionCriteria |
| Details |
refusal to give consent
known coagulopathy
secondary trigeminal neuralgia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain relief |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects |
6 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2019 |
| Date of Study Completion (India) |
27/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
We are planning a study of independent subjects with trigeminal neuralgia, planned to be treated with CRF & PRF with equal number of subjects in both groups. After getting approval from Ethical Committee, Dr.Ram Manohar Lohia Institute of Medical Sciences, Lucknow, UP, this prospective interventional study will be conducted in patients undergoing Radiofrequency treatment of Gasserian Ganglion. Group C- CRF group Conventional radiofrequency lesioning- 3 fractions delivered- (1) 60 degree C for 60 sec (2) 65 degree C for 60 sec (3) 70 degree C for 60 sec • Group P- PRF group Pulsed radiofrequency lesioning will be done @ 50 V with pulse delivered at every 20 msec for 10 mins with tip temperature of equal or less than 42°C |