| CTRI Number |
CTRI/2023/03/051197 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pulsed Radiofrequency Neuromodulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Greater occipital nerves Radio frequency neuromodulation for occipetal neuralgia. |
|
Scientific Title of Study
|
To study the effect of Pulse Radiofrequency neuromodulation of greater occipital nerve for occipital neuralgia: An Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajit Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
ajitdr.ajit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya Pal Mahiswar |
| Designation |
Senior Resident |
| Affiliation |
AIIMS,Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8962271102 |
| Fax |
|
| Email |
adityamahiswar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Pal Mahiswar |
| Designation |
Senior Resident |
| Affiliation |
AIIMS,Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS, Rishikesh
UTTARANCHAL
249203
India |
| Phone |
8962271102 |
| Fax |
|
| Email |
adityamahiswar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Division of Pain Medicine, Department of Anaesthesiology, AIIMS Rishikesh |
| 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 |
| Aditya Pal Mahiswar |
AIIMS RISHIKESH |
OT COMPLEX,Sixth floor,AIIMS Rishikesh
Dehradun
UTTARANCHAL |
8962271102
adityamahiswar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G588||Other specified mononeuropathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Greater occipital nerve block |
Greater occipital nerve block by 1 ml of 1% lignocaine |
| Intervention |
Pulsed Radiofrequency neuromodulation of greater occipital nerve |
2 cycle of Pulsed RFA of GON for 240 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients 18 to 60 years with diagnosed occipital neuralgia.
2.ASA I and ASA II patients.
3.Patient who gives written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Age < 18 yrs and >60yrs
2.ASA III and more
3.Patients recently undergone surgery (<3 months post-surgery)
4.Patients with bleeding disorders or infection at the site of intervention
5.Pregnant and lactating patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Rating Score (NRS) |
1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount and frequency of drug intake |
1 month and 3 month |
| Neuropathic pain score ( DN4) |
1 month and 3 month |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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
|
Plan for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
By this study we will look out for pian relief on the patients of greater occipetal neuralgia by treating them with PRF neuromodulation. |