| CTRI Number |
CTRI/2025/10/096122 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see whether an injection near the back of the head (greater occipital nerve block) can help reduce pain and headache days in people with chronic migraine |
|
Scientific Title of Study
|
Efficacy of Greater Occipital Nerve Intervention in Managing Chronic Migraine Headache |
| 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 Ravi Shankar Sharma |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Anesthesiology AIIMS Gorakhpur
Uttar pradesh
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9993116929 |
| Fax |
|
| Email |
drravishankarsharma4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AJAY AJAY |
| Designation |
Academic SR Pain Medicine |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Anesthesiology AIIMS Gorakhpur Uttar pradesh 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8053250658 |
| Fax |
|
| Email |
AJAY.PANWAR1307@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
AJAY AJAY |
| Designation |
Academic SR Pain Medicine |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Anesthesiology AIIMS Gorakhpur Uttar pradesh 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8053250658 |
| Fax |
|
| Email |
AJAY.PANWAR1307@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology AIIMS Gorakhpur Uttar pradesh 273008 India |
|
|
Primary Sponsor
|
| Name |
AIIMS Gorakhpur |
| Address |
All India Institute of Medical Science Kunraghat, Gorakhpur, Uttar Pradesh 273008 |
| 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 Ajay |
AIIMS Gorakhpur |
Department of Anaesthesia at first floor OT AIIMS Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
Gorakhpur
UTTAR PRADESH |
08053250658
AJAY.PANWAR1307@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee All india Institute of Medical Sciences, Gorakhpur, India-273008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Greater occipital nerve intervention |
A single session of ultrasound-guided unilateral greater occipital nerve block will be performed on the symptomatic side. Under full aseptic precautions, a high-frequency linear ultrasound probe will be used to identify the greater occipital nerve in the fascial plane between the semispinalis capitis and the inferior oblique capitis muscles.
A total of 3 mL solution containing 2 mL of 1% lignocaine with 8 mg dexamethasone will be injected perineurally around the nerve using an in-plane approach.
If pain reduction is less than 30% at 2 weeks, a repeat block may be administered.
All patients will receive standard migraine education and guidance on the use of acute rescue medications. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18–65 years.
2. Diagnosed with chronic migraine according to ICHD-3 .
3. Willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1.Secondary headache disorders.
2.Local infection at injection site.
3.Coagulopathy or anticoagulant use.
4.Known allergy to lignocaine or corticosteroids.
5.Pregnancy or lactation.
6.Severe psychiatric or cognitive impairment affecting compliance. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in mean pain intensity score after ultrasound-guided unilateral greater occipital nerve block |
Baseline , 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in migraine frequency.
2. Change in medication quantification scale.
3.Improvement in quality of life |
Baseline and 4 weeks post-intervention |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 |
|
Date of First Enrollment (India)
|
13/11/2025 |
| 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="1"
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
|
This study evaluate the efficacy of ultrasound-guided unilateral GON block using 1% lignocaine with 8 mg dexamethasone in chronic migraine.
Methods: Thirty-eight adults (18–65 yrs) with chronic migraine will receive a single ultrasound-guided GON block on the symptomatic side between the semispinalis capitis and inferior oblique capitis muscles.
Outcomes: Primary—Decrease in pain intensity using NRS at 4 weeks. Secondary-Reduction in migraine frequency, change in medication quantification scaleand quality of life.
Design: Single-arm, an interventional pilot study at AIIMS Gorakhpur.
|