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CTRI Number  CTRI/2025/11/097744 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Greater Occipital Nerve Block as a Treatment of Medication Overuse Headache (MOH-GON) Study 
Scientific Title of Study   Greater Occipital Nerve Block For Treatment of Medication Overuse Headache: A Randomized double blind placebo controlled 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  Vimal K Paliwal 
Designation  Professor, Neurology 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Neurology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, UP

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904631  
Fax    
Email  dr_vimalkpaliwal@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vimal K Paliwal 
Designation  Professor, Neurology 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Neurology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, UP

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904631  
Fax    
Email  dr_vimalkpaliwal@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Vimal K Paliwal 
Designation  Professor, Neurology 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Neurology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, UP

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904631  
Fax    
Email  dr_vimalkpaliwal@rediffmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, UP 226014 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vimal K Paliwal  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Department of Neurology, C Block
Lucknow
UTTAR PRADESH 		 8004904631

dr_vimalkpaliwal@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sanjay Gandhi Post Graduate Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G444||Drug-induced headache, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Greater Occipital Nerve Block  Greater Occipital Nerve Block with local anaesthetic drug (Lignocaine 2%) for medication overuse headache. 
Comparator Agent  No intervention  No intervention will be done and patients will be continued on previously taking prophylactic treatment for headache 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age more than 18 years
Patients giving informed consent
Patients fulfilling criteria for medication overuse headache 
 
ExclusionCriteria 
Details  Patients with secondary headache
Known allergy to lignocaine
Arnold chiari malformation or open skull defect
Patients on Oral anticoagulants or bleeding disorder
Pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
50% reduction in headache frequency   Week 4 and week 8 post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
50% reduction in headache severity based on visual analogue scale  Week 4 and week 8 post intervention 
Impact on functional disability based on headache impact test-6 (HIT-6) questionnaire  Week 4 and week 8 post intervention 
 
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   N/A 
Date of First Enrollment (India)   01/12/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr_vimalkpaliwal@rediffmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Medication-overuse headache is also known as analgesic rebound headache, drug-induced headache or medication-misuse headache. When patients with established primary headache disorders like migraine or tension-type headaches overuse medication for their acute headaches, medication-overuse inadvertently increases the frequency and intensity of their headaches, creating a vicious cycle of further drug consumption and increase in their headache frequency eventually transforming their headache from migraine or tension-type headache to medication-overuse headache. Greater occipital nerve blockade (GONB) is postulated to modulate the pain
pathway through its connections at trigemino-cervical complex (TCC). Prior to treatment, subjects will participate in a run-in period where they are instructed to record their pain on a visual analogue scale of 0 to 10 as well as hours of pain free time per day in a paper daily diary for one month (4 weeks) and headache disability assessed by HIT 6 questionnaire to ensure an adequate baseline for comparison. Patient will be continued on any previous prophylaxis medication however any acute treatment taken by patients fulfilling the duration for abuse will be stopped. However, any rescue medication taken by the patient during follow-up period will be noted in
both arms and the frequency and dosage will be analysed at the end of study. Eligible participants will undergo Randomization, and patients will be allocated to groups A or B (1:1) by investigator 1 into case (those who receive GONB 2ml 2% lignocaine bilaterally) and control (those who do not receive intervention) groups. The study will be a prospective study and assessment will be done by investigator 2, unaware of the treatment received by both group (blinded end point) at week 4 and week 8 post GONB with Primary outcome being 50% reduction in headache frequency and Secondary outcome being 50% reduction in headache severity based on VAS score and Impact on functional disability based on HIT-6 questionnaire. 
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