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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Mean change in weekly attack frequency from baseline to end of 4 weeks.
研究概览
简要总结
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:
-
Is GONB as a transitional preventive treatment for ECH more efficacious than placebo?
-
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1.Mean change in weekly attack frequency from baseline to end of 4 weeks.
时间窗: 4 weeks
次要结局
- Mean total number of attacks between day 1 and day 3 and their mean duration and severity.(Day 1 to Day 3)
- 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)
- 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)
- 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 change in weekly attack frequency from baseline to end of 1, 2 and 3 weeks.(Baseline to end of 1,2 and 3 weeks.)
- 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)
- 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)