| CTRI Number |
CTRI/2021/12/038397 [Registered on: 02/12/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of Greater Occipital Nerve Block as a transitional therapy in treatment of cluster headache |
|
Scientific Title of Study
|
A Double-blind Randomized Trial of Greater Occipital Nerve Block (GONB) of Methyl-prednisolone and Lignocaine versus Placebo as a Transitional Preventive Treatment for Episodic Cluster Headache |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debashish Chowdhury |
| Designation |
Director Professor and Head of Department |
| Affiliation |
GB Pant Institute of Post Graduate Medical Education and Research |
| Address |
Department of Neurology,
Maulana Azad Medical College and Associated GB Pant Institute of Post Graduate Medical Education and Research, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9718599306 |
| Fax |
|
| Email |
debuchoke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Rao Kordcal |
| Designation |
Senior Resident |
| Affiliation |
GB Pant Institute of Post Graduate Medical Education and Research |
| Address |
Department of Neurology,
Maulana Azad Medical College and Associated GB Pant Institute of Post Graduate Medical Education and Research, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9902126295 |
| Fax |
|
| Email |
sraokordcal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Rao Kordcal |
| Designation |
Senior Resident |
| Affiliation |
GB Pant Institute of Post Graduate Medical Education and Research |
| Address |
Department of Neurology,
Maulana Azad Medical College and Associated GB Pant Institute of Post Graduate Medical Education and Research, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9902126295 |
| Fax |
|
| Email |
sraokordcal@gmail.com |
|
|
Source of Monetary or Material Support
|
| GB Pant Institute of Post Graduate Medical Education and Research
New Delhi |
|
|
Primary Sponsor
|
| Name |
GB Pant Institute of Post Graduate Medical Education and Research |
| Address |
Jawahar Lal Nehru Marg,
New Delhi - 110002 |
| 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 Sanjay Rao Kordcal |
GB Pant Institute of Post Graduate Medical Education and Research |
Department of Neurology,
Fifth floor,
Academic Block,Jawahar Lal Nehru Marg,
New Delhi - 110002
Central
DELHI |
9902126295
sraokordcal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G440||Cluster headaches and other trigeminal autonomic cephalgias (TAC), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Greater occipital nerve block using methyl-prednisolone and lignocaine |
The site of injection shall be marked i.e. approximately two thirds of the distance on a line drawn from the center of the mastoid to the external occipital protuberance only if these points exhibited conspicious pain sensitivity to pressure. Prior to giving injection of GONB, on the marked point and an area surrounding it with 3cm diameter, lignocaine jelly will be applied topically to mask the effect of numbness following the GONB. Injection will be given on symptomatic side after 10 minutes of topical application of lignocaine. The patient will be positioned properly by slight neck flexion. The injection site will be cleaned with spirit to give GONB under aseptic precaution. One third of the injection will be injected in that area, one third slightly medially and one third slightly laterally. 80 mg of methylprednisolone (2ml) and 2ml of 2% lidocaine shall be injected. |
| Comparator Agent |
Greater occipital nerve block with 0.9% saline |
The site of injection shall be marked i.e. approximately two thirds of the distance on a line drawn from the center of the mastoid to the external occipital protuberance only if these points exhibited conspicious pain sensitivity to pressure. Prior to giving injection of GONB, on the marked point and an area suroounging it with 3cm diameter, lignocaine jelly will be applied topically to mask the effect of numbness following the GONB. Injection will be given on symptomatic side after 10 minutes of topical application of lignocaine. The patient will be positioned properly by slight neck flexion. The injection site will be cleaned with spirit to give GONB under aseptic precaution. One third of the injection will be injected in that area, one third slightly medially and one third slightly laterally. 4ml of 0.9% saline shall be injected. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 18–65 years who meet the international classification of headache disorders-3 (ICHD-3) diagnostic criteria for episodic (3.1.1) cluster headache(ECH).
2.ECH patients must have had atleast 1 cluster period (CP) prior to the current bout.
3.ECH patients should have 1 or more attacks per 24 h in the 7 days preceding the day of inclusion.
4.ECH patients also need to be in their present CP for no more than 2 weeks.
5.ECH patients who are not on preventive medications or who are on stable doses (without any dose change) of preventive medications for more than past 3 months shall be included.
|
|
| ExclusionCriteria |
| Details |
1.All patients who have clinical phenotype fulfilling the diagnostic criteria of ECH but on further investigation were found to have a secondary cause for their headaches will be excluded.
2.ECH patients who have always have CP less than 2 weeks.
3.Patients with ECH phenotype who have consistently headache attacks of less than 30 min duration which occur more than five times daily (as they are likely to be cases of paroxysmal hemicrania and therefore an indomethacin trial should be given).
4.ECH patients who have been recently started on preventive treatment in the last 3 months.
5.ECH patients who had a GONB in the last 3 months.
6.Patients who have a contraindication to methylprednisolone or lignocaine.
7.Patients who are on anticoagulants, or have a known bleeding disorder.
8.Pregnant females.
9.Patients who are using steroids for any other systemic or skin diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Mean change in weekly attack frequency from baseline to end of 4 weeks. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. The proportion of patients achieving complete remission of pain (disappearance of attacks) within 4days to 1st week (‘sustained attack- free day 4-1 week’), within 4days to 2nd week (‘sustained attack- free day 4-2 week’) and within 4days to 3rd week (‘sustained attack- free day 4-3 week’), within 4days for the entire 4-week follow-up period (‘sustained attack-free day 4- 4 weeks’). |
1) 4 days to 1st week
2) 4 days to 2nd week
3) 4 days to 3rd week
4) 4 days to 4th week |
| Mean change in weekly attack frequency from baseline to end of 1, 2 and 3 weeks. |
Baseline to end of 1,2 and 3 weeks. |
| Mean change in weekly attack severity and duration from baseline to end of 1, 2, 3 and 4 weeks. |
Baseline to end of 1,2,3 and 4 weeks. |
| Mean total number of attacks between day 1 and day 28 and their mean duration and severity. |
Day 1 to Day 2.
|
| Mean total number of attacks between day 1 and day 3 and their mean duration and severity. |
Day 1 to Day 3 |
| Proportions of patients needing repeat GONB at 4 weeks. |
4 weeks |
| Total number of times the specific acute treatment used during first 4 weeks. |
4 weeks |
| Proportion of patients requiring additional preventive treatment (verapamil, lithium or topiramate) from 1 to 4 weeks. |
1 to 4 weeks |
| Mean verapamil dose at 4 weeks. |
4 weeks |
| Changes in Headache Impact Test-6 (HIT-6) and Headache Disability Inventory (HDI) scores from baseline (at the time of randomization) to 4 weeks. |
Baseline to 4 weeks |
| Changes in the Cluster headache quality of life scale scores from baseline (at the time of randomization) to 4 weeks. |
Baseline to 4 weeks |
| Changes in the rates of cranial autonomic symptoms and restlessness from baseline to 4 weeks. |
Baseline to 4 weeks |
| Total number and type of adverse events and serious adverse events. |
4 weeks |
| Patient’s satisfaction at the end of 4 weeks. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/12/2021 |
| Date of Study Completion (India) |
10/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
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)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [debuchoke@gmail.com].
- For how long will this data be available start date provided 30-06-2023 and end date provided 31-03-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - None
|
|
Brief Summary
|
ANODYNE Study
AIM: To study and compare the efficacy and safety of GONB injections using 2ml methylprednisolone (80mg) and 2ml lignocaine (2%) versus placebo (4 ml saline injections) as a transitional preventive treatment for Episodic Cluster Headache.
LACUNAE: Efficacy and safety of Greater Occipital Nerve Block (GONB) as a transitional preventive treatment for ECH lacks robust evidence.
RESEARCH QUESTION: 1. Is GONB as a transitional preventive treatment for ECH more efficacious than placebo? 2. What is the tolerability profile of GONB in patients of ECH?
Study type: The study will be a double blind placebo controlled trial. Study area: All consecutive patients of episodic cluster headache attending the Headache Clinic at GIPMER, New Delhi will be evaluated for the inclusion in the study. Study period: Overall, the study duration shall be 18 months. Study Population: The subjects will be consecutive episodic cluster headache patients.
Assessment of Patients:
Routine evaluation: All patients will be evaluated as per a detailed structured proforma covering demography and all aspects of clinical characteristics of headache. Detailed assessment of cranial autonomic symptoms and signs and restlessness during the attacks will be made based on a questionnaire. Relevant biochemical (hemogram, kidney, liver and thyroid function tests) and radiological tests (MRI brain) will be done to exclude secondary causes. Impact of headache will be assessed by Headache impact test (HIT6) 7 and headache related disability will be assessed by headache disability inventory (HDI) 8 and VAS scale9 for severity of headache. The cluster headache quality of life scale10 will be used to measure quality of life before and after the intervention. A simple verbal scale will be used to indicate the level of patient satisfaction with treatment: poor, moderate, good, excellent.
Follow-up: There will be a total of 5 visits during the double blind phase and 3 visits in the open label phase as shown in the trial design figure. All the patients will be asked to fill the headache diary and a diary for any adverse events.
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